NEPHROCHECK Calibration Verification Kit Package Insert

Transcription

1 NEPHROCHECK Verifiation Kit Pakage Insert Manufatured for Astute Medial, In General Atomis Ct. Building 2 San Diego, CA USA Intended Use The NEPHROCHECK Verifiation (Cal Vers) Materials are to verify alibration of the NEPHROCHECK Test System. Reagents The NEPHROCHECK Verifiation Kit inludes five levels of lyophilized material prepared from human urine (olleted from apparently healthy donors), as well as human TIMP-2 (Tissue Inhibitor of Metalloproteinase 2) and human IGFBP-7 (Insulin-like Growth Fator Binding Protein 7) proteins with protein stabilizers. TIMP-2 and IGFBP-7 proteins have been added to the urine to ahieve speified target onentration levels that evenly span the reportable ranges. The expeted onentrations and standard deviations are printed on the NEPHROCHECK Expeted Values Card enlosed with the NEPHROCHECK Verifiation Kit. Warnings and Preautions The operator should use Standard Preautions when performing the NEPHROCHECK Test or operating the ASTUTE140 Meter. All human soure material used to manufature this produt was non-reative for antigens to Hepatitis B (HBsAg), negative by tests for antibodies to HIV (HIV-1/HIV-s) and Hepatitis C (HCV), non-reative for HIV-1 RNA and HCV RNA by liensed NAT, and non-reative to Serologial Test for Syphilis (STS) using FDA-approved testing methods. For in vitro diagnosti use. Do not use the kit beyond the expiration date printed on the outside of the box. The NEPHROCHECK Verifiation Kit ontains materials of human origin (urine). Handle these materials as if they are potentially infetious. Proper handling and disposal methods in ompliane with federal and loal regulations should be established. The NEPHROCHECK Verifiation Kit is to be used only with the NEPHROCHECK Test and ASTUTE140 Meter. Use only NEPHROCHECK Verifiation Kits with the NEPHROCHECK Test System. Astute Medial, In PN Rev F 2017/02/16

2 NEPHROCHECK Verifiation Kit Pakage Insert 2 The NEPHROCHECK Verifiation Kit requires the use of alibrated preision pipette(s). It is reommended that the users review the proper proedures for the use of these devies in order to ensure aurate dispensing of volumes. Storage and Stability The NEPHROCHECK Verifiation material is lyophilized. Prior to opening the NEPHROCHECK Verifiation Kit, inspet the vials for raks, hips or broken seals. Do not use any vials if you enounter any damage. Prior to opening the NEPHROCHECK Verifiation Kit, verify that the ontents within eah vial appear dry. Do not use any and Verifiation kit vial if the ontents appear to be wet. Ensure the reonstituted NEPHROCHECK Verifiation Material is ompletely dissolved prior to use. Do not use if ontents do not appear to be fully dissolved. One opened and reonstituted, eah NEPHROCHECK Verifiation Kit Vial is stable for 8 hours when stored apped at room temperature C (68 77 F). Eah NEPHROCHECK Verifiation Kit Vial is intended for single use only. Eah NephroChek and Verifiation Kit Vial should not be stored after opening or use. Eah unopened NEPHROCHECK Verifiation Kit Vial is stable until the expiration date printed on the box when stored refrigerated or frozen between -20 C 4 C (-4 F 39.2 F). Materials Provided NEPHROCHECK and Verifiation Kit (part number ) ontaining: NEPHROCHECK Verifiation Vial Level 1 NEPHROCHECK Verifiation Vial Level 2 NEPHROCHECK Verifiation Vial Level 3 NEPHROCHECK Verifiation Vial Level 4 NEPHROCHECK Verifiation Vial Level x 500 µl (lyophilized) NEPHROCHECK Verifiation Kit Pakage Insert... 1 NEPHROCHECK Verifiation Expeted Values Card... 1 Materials Required But Not Provided ASTUTE140 Meter Kit (PN ) NEPHROCHECK Test Kit (PN ) NEPHROCHECK Test Buffer Solution (inluded in the NEPHROCHECK Test Kit) Calibrated preision pipette, apable of dispensing 100 µl and 500 µl Quality Control Considerations Good Laboratory Pratie suggests that the NEPHROCHECK Verifiation Kit should be tested: At least one every 6 months After ASTUTE140 Meter maintenane or serviing In aordane with loal, state, and/or federal regulations or areditation requirements and Verifiation Proedure NOTE: THE NEPHROCHECK Verifiation vials should be prepared following the proedures for preparing and testing patient samples with the NEPHROCHECK Test. (For more details, see the NEPHROCHECK Test Pakage Insert) Prepare eah NEPHROCHECK Verifiation Kit Vial as follows: 1. Configure the ASTUTE140 Meter to test the Verifiation vial (See Testing a Patient Sample in the ASTUTE140 Meter User Manual for detailed instrutions). NOTE: When prompted for Patient ID, enter 001, 002, 003, 004, or 005 orresponding to eah NEPHROCHECK Verifiation Vial level to be run. Astute Medial, In PN Rev F 2017/02/16

3 NEPHROCHECK Verifiation Kit Pakage Insert 3 2. Remove the ap from a single NEPHROCHECK Verifiation Vial (Level 1, 2, 3, 4 or 5). 3. Add 500 µl deionized water using a alibrated, preision pipette. 4. Reap the vial and invert the vial three times to mix. 5. Visually onfirm the lyophilized material is ompletely dissolved before use. 6. Remove a new NEPHROCHECK Test Cartridge and NEPHROCHECK Test Conjugate Vial from the foil pouh and plae on a flat surfae. 7. Eah NEPHROCHECK Test Conjugate Vial ontains a single onjugate bead. Remove the ap from the NEPHROCHECK Test Conjugate Vial. Visually inspet the ap and vial to ensure that the onjugate bead has not adhered to the ap and is present in the vial. If the bead has adhered to the ap, plae the ap on the vial and tap three times. Repeat if neessary until the bead drops into the vial. Do not touh the bead or attempt to remove the bead from the ap by any other means. 8. Pipette 100 µl of NEPHROCHECK Test Buffer Solution (inluded in the NEPHROCHECK Test Kit) into the onjugate vial ontaining the onjugate bead. This will result in reonstitution of the onjugate bead into solution. 9. Pipette 100 µl of reonstituted NEPHROCHECK Verifiation solution into the NEPHROCHECK Test Conjugate Vial that now ontains the reonstituted onjugate bead solution. Mix thoroughly (mix at least three times using the pipette tip). 10. Pipette 100 µl of mixed Conjugate Vial solution into the designated sample port on the NEPHROCHECK Test artridge. Wait approximately one minute for the sample to be absorbed into the round well. 11. Using the grips on the side of the NEPHROCHECK Test artridge, position the artridge inside the ASTUTE140 Meter drawer with the Astute Medial logo towards the inside of the meter drawer. Keep the NEPHROCHECK Test artridge horizontal and avoid tipping the test artridge during plaement into the ASTUTE140 Meter drawer. 12. Close the ASTUTE140 Meter drawer. In approximately 20 minutes the and Verifiation result will be displayed (The NEPHROCHECK Test inubation time must be 25 minutes from the sample inubation time set in the ASTUTE140 Meter). The ASTUTE140 Meter will display a single numerial value per level run. 13. Press the key to open the ASTUTE140 Meter drawer. Eah alibration verifiation vial and onjugate vial is intended for single use only. Remove the NEPHROCHECK Test artridge and disard the artridge, the Verifiation Vial, and the onjugate vial in aordane with loal regulations. The NEPHROCHECK Verifiation Kit Vial is intended for single use only. 14. Repeat steps 1 13 for the remaining four levels of NEPHROCHECK Verifiation Kit Vials. Astute Medial, In PN Rev F 2017/02/16

4 NEPHROCHECK Verifiation Kit Pakage Insert 4 NEPHROCHECK Verifiation Preparation Proess Results The ASTUTE140 Meter automatially alulates a single numerial risk result for eah NEPHROCHECK Verifiation level that is tested. This result is displayed on the ASTUTE140 Meter sreen after the NEPHROCHECK Test proedure is ompleted; results for the individual markers are not displayed. Compare the displayed result with the information provided on the bak of the NEPHROCHECK Expeted Values Card to ensure the results fall within the published ranges. If any of the levels fall outside the aeptable range, test that speifi level again using a new NEPHROCHECK Test Kit. If it does not fall into the assigned range after re-testing, ontat Astute Medial Tehnial Support. The NEPHROCHECK Test results are also stored in the ASTUTE140 Meter memory and may be aessed at any time (See Review and Management of Test Results in the ASTUTE140 Meter User Manual). Expeted Results Expeted values are determined by testing the NEPHROCHECK Verifiation materials with the NEPHROCHECK Test during produt manufaturing. The expeted value ranges are determined from the average and standard deviation of these testing results. Standardization The NEPHROCHECK Verifiation Kit is traeable to referene standard solutions that ontain defined mass (onentration) of TIMP-2 and IGFBP-7 proteins, in aordane with EN ISO The NEPHROCHECK Verifiation materials and NEPHROCHECK Test artridges are traeable to the same referene standard solutions. Limitations of the Proedure The ranges given for the expeted values are intended only as guidelines. Laboratories should determine their ranges and standard deviations based on their own testing poliies and tolerane limits. Ordering and Contat Information NEPHROCHECK Verifiation Kit (PN ) For questions regarding the use or performane of the NEPHROCHECK Verifiation Kit or any Astute Medial, In. produt, please ontat Astute Tehnial Support. Contat Information Astute Medial, In General Atomis Ct. Building 2 San Diego, CA USA Phone: +1 (855) (Monday thru Friday, 8am 5pm PST) Fax: +1 (858) tehnialsupport@astutemedial.om Website: Astute Medial, In PN Rev F 2017/02/16

5 NEPHROCHECK Verifiation Kit Pakage Insert 5 s Glossary Standard Referene Title Referene Number a Manufaturer a Consult instrutions for use a Catalogue number a Bath ode a In vitro diagnosti medial devie a Use-by date a Do not re-use a Temperature limit a Biologial risks b Average, Sample mean 1.15 Desription as Provided by the Referened Standard Indiates the medial devie manufaturer, as defined in EU Diretives 90/385/EEC, 93/42/EEC and 98/79/EC. Indiates the need for the user to onsult the instrutions for use. Indiates the manufaturer's atalogue number so that the medial devie an be identified. Indiates the manufaturer's bath ode so that the bath or lot an be identified. Indiates a medial devie that is intended to be used as an in vitro diagnosti medial devie. Indiates the date after whih the medial devie is not to be used. Indiates a medial devie that is intended for one use, or for use on a single patient during a single proedure. Indiates the temperature limits to whih the medial devie an be safely exposed. Indiates that there are potential biologial risks assoiated with the medial devie. Arithmeti mean; sum of random variables in a random sample divided by the number of terms in the sum b Standard Deviation 2.37 Positive square root of the variane Kit Contents -- Kit Contents Expeted values -- Expeted values Expeted Values Card Verifiation (Cal Vers) Kit Verifiation Vial 1 Verifiation Vial 2 Verifiation Vial 3 -- Expeted Values Card -- Verifiation (Cal Vers) Kit -- Verifiation Vial 1 -- Verifiation Vial 2 -- Verifiation Vial 3 Astute Medial, In PN Rev F 2017/02/16

6 NEPHROCHECK Verifiation Kit Pakage Insert 6 Standard Referene Title Referene Number Desription as Provided by the Referened Standard Verifiation Vial 4 -- Verifiation Vial 4 Verifiation Vial 5 -- Verifiation Vial 5 Legend for Standard Referene (designation number and title): a) ANSI/AAMI/ISO :2012 & ISO Seond edition, Medial Devies to be used with medial devie labels, labeling and information to be supplied Part 1: General requirements b) ISO :2006 Seond Edition Statistis Voabulary and symbols Part 1: General statistial terms and terms used in probability ) ontaining explanatory text for larity End User Liense Agreement PURCHASE AND/OR USE OF THIS PRODUCT SHALL CONSTITUTE ACKNOWLEDGMENT AND ACCEPTANCE OF THE TERMS AND CONDITIONS OF THIS END USER LICENSE AGREEMENT Astute Medial, In. (together with its affiliates, Astute ) hereby grants to the purhaser/user ( you, your ) of this produt the limited liense to use this produt solely for the purpose as speified on the approved label therefor. You hereby agree that you shall use this produt solely for suh purpose and for no other purpose. If you do not agree with eah of the terms and onditions set forth in this End User Liense Agreement, please ontat Astute within ten (10) days after reeipt of this produt to return the unused and unopened produt for a full refund. LIMITED WARRANTY. FOR THE APPLICABLE WARRANTY PERIOD, ASTUTE WARRANTS THAT THIS PRODUCT SHALL BE (A) OF GOOD QUALITY AND FREE OF MATERIAL DEFECTS, (B) FUNCTION IN ACCORDANCE WITH THE MATERIAL SPECIFICATIONS REFERENCED IN THE PRODUCT MANUAL, AND (C) APPROVED BY THE PROPER GOVERNMENTAL AGENCIES REQUIRED FOR THE SALE OF PRODUCTS FOR THEIR INTENDED USE AS DESCRIBED IN THE APPLICABLE PRODUCT MANUAL OR INSERT THROUGHOUT THE PRINTED EXPIRATION DATE, OR IN THE CASE OF THE ASTUTE140 METER FOR A PERIOD OF TWELVE (12) MONTHS FROM THE DATE OF SHIPMENT (THE LIMITED WARRANTY ). IF THIS PRODUCT FAILS TO MEET THE REQUIREMENTS OF THIS LIMITED WARRANTY, THEN AS YOUR SOLE REMEDY, ASTUTE SHALL EITHER REPAIR OR REPLACE, AT ASTUTE DISCRETION, THIS PRODUCT. EXCEPT FOR THE LIMITED WARRANTY STATED IN THIS SECTION, TO THE EXTENT PERMITTED UNDER APPLICABLE LAW, ASTUTE DISCLAIMS ANY AND ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT REGARDING THIS PRODUCT. ASTUTE S MAXIMUM LIABILITY FOR ANY CUSTOMER CLAIM SHALL NOT EXCEED THE NET PRODUCT PRICE PAID THEREFOR. NO PARTY SHALL BE LIABLE TO ANY OTHER PARTY FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, OR LOSS OF BUSINESS, PROFITS, DATA OR REVENUE, EVEN IF A PARTY RECEIVES NOTICE IN ADVANCE THAT THESE KINDS OF DAMAGES MIGHT RESULT. The Limited Warranty above shall not apply if this produt has been subjeted to physial abuse, misuse, abnormal use, use inonsistent with the produt manual or insert, fraud, tampering, unusual physial stress, negligene or aidents. Any warranty laim pursuant to the Limited Warranty shall be made in writing within the appliable Limited Warranty period. You agree to use this produt in strit aordane with all appliable loal, state and federal laws, regulations and guidelines, and industry praties. You further agree that you shall not resell or otherwise transfer this produt to any other person or entity, without the prior express written approval of Astute Medial, In. Information about ommerial resale or distribution of the produts of Astute Medial, In. may be obtained by ing us at info@astutemedial.om or by writing to us at Astute Medial In., General Atomis Court, MS 02/641, San Diego, CA, 92121, USA. No amendment or addition to this End User Liense Agreement shall be binding upon the parties unless redued to writing and signed by the respetive authorized offiers of the parties Astute Medial, In. Astute Medial, the AM logo, Astute140, NephroChek, the NephroChek logo and AKIRISK are registered trademarks of Astute Medial, In. in the United States. For information regarding trademarks and other intelletual property appliable to this produt, please see AstuteMedial.om/US/About/IntelletualProperty. PN 0311 Rev B 2017/02/14 Astute Medial, In PN Rev F 2017/02/16