(212 days)
Not Found
No
The device description focuses on immunoassay technology and a calculation to derive a risk score based on biomarker concentrations, with no mention of AI or ML algorithms.
No
Explanation: The device is intended as an aid in risk assessment for acute kidney injury (AKI) by measuring biomarkers, not for treating or preventing disease.
Yes
The device is intended "as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment," which serves a diagnostic purpose.
No
The device description clearly outlines multiple hardware components including a test kit (cartridge, buffer, conjugate vial), a meter (bench-top analyzer with LCD screen and printer), liquid controls, and calibration verification kits. It is a system that includes both hardware and software components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is used "in conjunction with clinical evaluation" and as an "aid in the risk assessment" for acute kidney injury. This indicates that it is used to provide information about a patient's health status based on a biological sample.
- Device Description: The description details a "Test Kit" that performs "immunoassays for the protein biomarkers, insulin-like growth factor-binding protein (IGFBP7) and tissue-inhibitor of metalloproteinases 2 (TIMP-2) on a membrane test strip." It also mentions applying a "clinical urine sample" to the cartridge. This clearly describes a test performed on a sample taken from the human body to detect specific substances.
- Sample Type: The device uses a "clinical urine sample." Urine is a biological specimen.
- Measurement: The system measures the concentrations of specific protein biomarkers (TIMP-2 and IGFBP-7) in the urine sample.
- Result Interpretation: The concentrations of these proteins are used to derive an "AKIRISK™ Score," which is used as an aid in risk assessment for AKI. This score is a diagnostic output based on the in vitro test.
- Controls and Calibration: The description mentions "Liquid Controls Kit" and "Calibration Verification (Cal Vers) Kit," which are standard components of IVD systems used to ensure the accuracy and reliability of the test results.
Based on these points, the Astute Medical NEPHROCHECK® Test System fits the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of transfusions, or concerning the selection of blood donors to assess the safety of transfused blood.
N/A
Intended Use / Indications for Use
The Astute Medical NEPHROCHECK® Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK® Test System is intended to be used in patients 21 years of age or older.
Product codes (comma separated list FDA assigned to the subject device)
PIG
Device Description
The Astute NEPHROCHECK® Test System is comprised of the NEPHROCHECK® Test Kit, the ASTUTE140® Meter Kit, NEPHROCHECK® Liquid Controls Kit and the NEPHROCHECK® Calibration Verification (Cal Vers) Kit. The system is designed to be used by trained medical professionals in the central laboratory.
The NEPHROCHECK® Test Kit, includes the NEPHROCHECK® Test which is a single-use cartridge comprised of two immunoassays for the protein biomarkers, insulin-like growth factor-binding protein (IGFBP7) and tissue-inhibitor of metalloproteinases 2 (TIMP-2) on a membrane test strip enclosed in a plastic housing. The concentrations of the TIMP-2 and IGFBP-7 proteins are used to derive an AKIRISK™ Score. The test procedure involves the operator applying a clinical urine sample mixed with labeled fluorescent conjugate to the NEPHROCHECK® Test cartridge, and then inserting the Test cartridge into the ASTUTE140® Meter for incubation, reading, result calculation and result display. Internal positive and negative procedural controls in each NEPHROCHECK® Test cartridge monitor the function of each test cartridge. If the automatic check of these procedural controls shows that the control value results are not within pre-defined limits, the ASTUTE140® Meter will display an error message and the Test result will not be reported.
Included in the NEPHROCHECK® Test is test buffer and the NEPHROCHECK® Test Conjugate Vial which contains murine monoclonal and goat polyclonal antibodies against TIMP-2 and IGFBP-7, fluorescent dye, stabilizers and excipients. Each Kit has the materials necessary to perform 25 tests. Each NEPHROCHECK® Test Kit also contains a lot-specific radio-frequency identification (RFID) card containing lot and calibration information. The RFID card information must be loaded prior to using a new Test kit lot.
The AsTUTE140® Meter is a bench-top analyzer that converts the fluorescent signal from each of the two immunoassays (TIMP-2 and IGFBP7) contained within the NEPHROCHECK® Test cartridge into the AKIRISK™ Score. The NEPHROCHECK® Test result is displayed on the Meter LCD screen in approximately 20 minutes from the addition of the specimen. Only the AKIRISK™ Score appears on the Meter display. The AsTUTE140® Meter contains an internal printer that can print the AKIRisk score.
The NEPHROCHECK® Low Liquid Control and NEPHROCHECK® High Liquid Control are bi-level, lyophilized control materials prepared from human urine containing human TIMP-2 and human IGFBP7 proteins with protein stabilizers. TIMP-2 and IGFBP-7 proteins have been added to the urine to achieve specified target concentration levels. Each NEPHROCHECK® Liquid Controls Kit also contains a high and low RFID encoded with the Liquid Control Kit lot number, expiration date, and the expected range of concentration values based on + two standard deviations in the measurement of each protein biomarker (TIMP-2 and IGFBP-7) in each Liquid Control level. Each NEPHROCHECK® Liquid Control Kit Vial is intended for single use only.
The NEPHROCHECK® Calibration Verification Kit includes five levels of lyophilized material prepared from human urine, containing TIMP-2 and human IGFBP-7 to achieve specified target concentration levels that evenly span the reportable range of the AKIRISK™ Score. The expected concentrations and standard deviations of the individual biomarkers are printed on an enclosed Expected Values Card.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
21 years of age or older
Intended User / Care Setting
trained medical professionals in the central laboratory.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The modified NEPHROCHECK® Test Kit was tested to verify its' performance for the following parameters:
- NEPHROCHECK® Test Kit - Interfering Substances - Myoglobin
- NEPHROCHECK® Test Kit - Shelf-Life 2-8°C Storage and Ambient Shipping
- NEPHROCHECK® Test Kit – Buffer Open-Bottle Shelf-Life
- NEPHROCHECK® Test Kit – Manufacturing and End-User Room Temperature Handling (Post 2-8°C Storage)
- NEPHROCHECK® Test Kit – Effect of Cycling Between 2-8°C Storage and Room Temperature
- Time of the NEPHROCHECK® Test Cartridge to Reach Operating Temperature After 2-8°C Storage
- NEPHROCHECK® Test Kit - Zero Equilibration Time Study
- NEPHROCHECK® Test Kit - Packaging Material Environmental Cycling Study
- Addition of a second supplier for anti-IGFBP-7
The NEPHROCHECK® Test Kit met its specifications. No new risks were introduced by the minor modifications described in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1220 Acute kidney injury test system.
(a)
Identification. An acute kidney injury test system is a device that is intended to measure one or more analytes in human samples as an aid in the assessment of a patient's risk for developing acute kidney injury. Test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must detail an appropriate end user device training program that will be offered while marketing the device as part of your efforts to mitigate the risk of incorrect interpretation of test results.
(2) As part of the risk management activities performed as part of your 21 CFR 820.30 design controls, you must document the appropriate end user device training program provided in your premarket notification submission to satisfy special control 21 CFR 862.1220(b)(1) that will be offered while marketing the device as part of your efforts to mitigate the risk of incorrect interpretation of test results.
(3) Robust clinical data demonstrating the positive predictive value, negative predictive value, sensitivity and specificity of the test in the intended use population must be submitted as part of the premarket notification submission.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an image of three stylized human profiles facing to the right, stacked on top of each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ASTUTE MEDICAL, INC. C/O JANICE HOGAN, PARTNER HOGAN LOVELLS US LLP 1835 MARKET STREET, 29TH FLOOR PHILADELPHIA PA 19103
June 9, 2016
Re: K153165
Trade/Device Name: NEPHROCHECK Test System Regulation Number: 21 CFR 862.1220 Regulation Name: Acute Kidney Injury Test System Regulatory Class: II Product Code: PIG Dated: May 3, 2016 Received: May 3. 2016
Dear Janice Hogan:
This letter corrects our substantially equivalent letter of June 1, 2016.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For :
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known) K153165
Device Name NEPHROCHECK® Test System
Indications for Use (Describe)
The Astute Medical NEPHROCHECK® Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK® Test System is intended to be used in patients 21 years of age or older.
| Type of Use (Select one or both, as applicable) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including |
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
Page 1 of 1 FDA
PSC Publishing Services (301) 443-6740 EF
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510(k) SUMMARY
Astute Medical Inc.'s Modified NEPHROCHECK® Test System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Astute Medical, Inc.
3550 General Atomics Ct.
Building 2
San Diego, CA 92121
- Phone: +1.858.500.7044
- Facsimile: +1.858.882.0449
- Contact Person: Karin A. Hughes, Ph.D.
- Date Prepared: May 13, 2016
Name of Device:
NEPHROCHECK® Test System
Common or Usual Name:
NEPHROCHECK® Test System
Classification Name:
Acute Kidney Injury Test System (21 C.F.R. 862.1220, Product Code PIG)
Panel:
Clinical Chemistry
Device Classification:
Class II
Predicate Device:
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Name: NEPHROCHECK® Test System
Device Company: Astute Medical, Inc.
510(k) Number: K131650
De Novo Number: DEN130031
Purpose of the Special 510(k) Notice:
The modified NEPHROCHECK® Test System is a modification to the previously cleared NEPHROCHECK® Test System. Modifications included in this Special 510(k) submission include:
- Labeling changes to the NEPHROCHECK® Test instructions for use add myoglobin as a . substance that does not exhibit interference with the AKIRisk Score in the "Interfering Substances" section of the Performance Characteristics section.
- . Labeling changes to the "Storage and Handling Requirements" section of the NEPHROCHECK® Test instructions for use to describe the stability of the NEPHROCHECK® Test Kit when stored refrigerated.
- Addition of a second supplier for anti-IGFBP-7 .
Indication for Use:
The Astute Medical NEPHROCHECK® Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK® Test System is intended to be used in patients 21 years of age or older.
Device Description:
The Astute NEPHROCHECK® Test System is comprised of the NEPHROCHECK® Test Kit, the ASTUTE140® Meter Kit, NEPHROCHECK® Liquid Controls Kit and the NEPHROCHECK® Calibration Verification (Cal Vers) Kit. The system is designed to be used by trained medical professionals in the central laboratory.
The NEPHROCHECK® Test Kit, includes the NEPHROCHECK® Test which is a single-use cartridge comprised of two immunoassays for the protein biomarkers, insulin-like growth factor-binding protein (IGFBP7) and tissue-inhibitor of metalloproteinases 2 (TIMP-2) on a membrane test strip enclosed in a plastic housing. The concentrations of the TIMP-2 and IGFBP-7 proteins are used to derive an AKIRISK™ Score. The test procedure involves the operator applying a clinical urine sample mixed with labeled fluorescent conjugate to the NEPHROCHECK® Test cartridge, and then inserting the Test cartridge into the ASTUTE140® Meter for incubation, reading, result calculation and result display. Internal positive and negative procedural controls in each NEPHROCHECK® Test cartridge monitor the function of each test cartridge. If the automatic check of these procedural controls shows that the control value results are not within pre-defined limits, the ASTUTE140® Meter will display an error message and the Test result will not be reported.
5
Included in the NEPHROCHECK® Test is test buffer and the NEPHROCHECK® Test Conjugate Vial which contains murine monoclonal and goat polyclonal antibodies against TIMP-2 and IGFBP-7, fluorescent dye, stabilizers and excipients. Each Kit has the materials necessary to perform 25 tests. Each NEPHROCHECK® Test Kit also contains a lot-specific radio-frequency identification (RFID) card containing lot and calibration information. The RFID card information must be loaded prior to using a new Test kit lot.
The AsTUTE140® Meter is a bench-top analyzer that converts the fluorescent signal from each of the two immunoassays (TIMP-2 and IGFBP7) contained within the NEPHROCHECK® Test cartridge into the AKIRISK™ Score. The NEPHROCHECK® Test result is displayed on the Meter LCD screen in approximately 20 minutes from the addition of the specimen. Only the AKIRISK™ Score appears on the Meter display. The AsTUTE140® Meter contains an internal printer that can print the AKIRisk score.
The NEPHROCHECK® Low Liquid Control and NEPHROCHECK® High Liquid Control are bi-level, lyophilized control materials prepared from human urine containing human TIMP-2 and human IGFBP7 proteins with protein stabilizers. TIMP-2 and IGFBP-7 proteins have been added to the urine to achieve specified target concentration levels. Each NEPHROCHECK® Liquid Controls Kit also contains a high and low RFID encoded with the Liquid Control Kit lot number, expiration date, and the expected range of concentration values based on + two standard deviations in the measurement of each protein biomarker (TIMP-2 and IGFBP-7) in each Liquid Control level. Each NEPHROCHECK® Liquid Control Kit Vial is intended for single use only.
The NEPHROCHECK® Calibration Verification Kit includes five levels of lyophilized material prepared from human urine, containing TIMP-2 and human IGFBP-7 to achieve specified target concentration levels that evenly span the reportable range of the AKIRISK™ Score. The expected concentrations and standard deviations of the individual biomarkers are printed on an enclosed Expected Values Card.
Technological Characteristics:
The modified NEPHROCHECK® Test System has very similar technological characteristics as the previously cleared NEPHROCHECK® Test System, to which it is a modification. There have been no changes to the technological features between the modified NEPHROCHECK® Test System and the previously cleared NEPHROCHECK® Test System; the minor differences between the modified NEPHROCHECK® Test System and the previously cleared NEPHROCHECK® Test System do not raise any new questions of safety or effectiveness. The NEPHROCHECK® Test System final release specifications as cleared in DEN130031/K131650 are not impacted by these minor changes. Bench testing was conducted and the results from this testing demonstrate that the modified NEPHROCHECK® Test System is substantially equivalent to the previously cleared NEPHROCHECK® Test System ("predicate device").
Modifications included in this Special 510(k) submission include:
- . Labeling changes to the NEPHROCHECK® Test instructions for use to add myoglobin as a substance that does not exhibit interference with the AKIRisk™ Score in the "Interfering Substances" section of the Performance Characteristics section.
6
- . Labeling changes to the "Storage and Handling Requirements" section of the NEPHROCHECK® Test instructions for use to describe the stability of the NEPHROCHECK® Test Kit and components.
- Addition of a second supplier for anti-IGFBP-7 antibody .
Performance Data:
The modified NEPHROCHECK® Test Kit was tested to verify its' performance for the following parameters:
| Study | Standards Referenced |
|---|---|
| NEPHROCHECK® Test Kit - Interfering | |
| Substances - Myoglobin | CLSI EP07-A2:2005, Interference |
| Testing in Clinical Chemistry; Approved | |
| Guideline- 2nd Edition | |
| NEPHROCHECK® Test Kit - Shelf-Life 2-8°C | |
| Storage and Ambient Shipping | CLSI EP25-A:2009 Evaluation of |
| Stability of In Vitro Diagnostic Reagents; | |
| Approved Guideline; BS EN ISO 23640:2013 Stability testing | |
| of in vitro diagnostic reagent; ASTM D4332-13 Standard Practice for | |
| Conditioning Containers, Packages, or | |
| Packaging Components for Testing; ISTA 7E:2010 Testing Standard for | |
| Thermal Transport Packaging Used in | |
| Parcel Delivery System Shipment | |
| NEPHROCHECK® Test Kit – Buffer Open-Bottle | |
| Shelf-Life | CLSI EP25-A:2009 Evaluation of |
| Stability of In Vitro Diagnostic Reagents; | |
| Approved Guideline; BS EN ISO 23640:2013 Stability testing | |
| of in vitro diagnostic reagent; ASTM D4332-13 Standard Practice for | |
| Conditioning Containers, Packages, or | |
| Packaging Components for Testing; ISTA 7E:2010 Testing Standard for | |
| Thermal Transport Packaging Used in | |
| Parcel Delivery System Shipment | |
| NEPHROCHECK® Test Kit – Manufacturing and | |
| End-User Room Temperature Handling (Post | |
| 2-8°C Storage) | CLSI EP25-A:2009 Evaluation of |
| Stability of In Vitro Diagnostic Reagents; | |
| Approved Guideline; BS EN ISO 23640:2013 Stability testing | |
| of in vitro diagnostic reagent; ASTM D4332-13 Standard Practice for | |
| Conditioning Containers, Packages, or | |
| Packaging Components for Testing; ISTA 7E:2010 Testing Standard for | |
| Thermal Transport Packaging Used in | |
| Parcel Delivery System Shipment | |
| Study | Standards Referenced |
| NEPHROCHECK® Test Kit – Effect of Cycling | |
| Between 2-8°C Storage and Room | |
| Temperature | • EP07-A2:2005 Interference Testing in |
| Clinical Chemistry; Approved Guideline- | |
| 2nd Edition. | |
| Time of the NEPHROCHECK® Test Cartridge to | |
| Reach Operating Temperature After 2-8°C | |
| Storage | • EP07-A2:2005 Interference Testing in |
| Clinical Chemistry; Approved Guideline- | |
| 2nd Edition. | |
| NEPHROCHECK® Test Kit - Zero Equilibration | |
| Time Study | • EP07-A2:2005 Interference Testing in |
| Clinical Chemistry; Approved Guideline- | |
| 2nd Edition. | |
| NEPHROCHECK® Test Kit - Packaging Material | |
| Environmental Cycling Study | • ASTM D4332-13 Standard Practice for |
| Conditioning Containers, Packages, or | |
| Packaging Components for Testing | |
| Addition of a second supplier for anti-IGFBP-7 | • CLSI EP17-A2, Evaluation of Detection |
| Capability for Clinical Laboratory | |
| Measurement Procedures; Approved | |
| Guideline—Second Edition |
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The NEPHROCHECK® Test Kit met its specifications. No new risks were introduced by the minor modifications described in this submission.
Substantial Equivalence
The company's modified NEPHROCHECK® Test System is a modification to the previously cleared NEPHROCHECK® Test System (DEN130031/K131650), which was cleared in September 2014. The modified NEPHROCHECK® Test System has the same intended use and indications for use, similar principles of operation, and similar technological characteristics as the previously cleared predicate NEPHROCHECK® Test System. The only labeling modifications that are being implemented for the modified device are minor updates to indicate that myoglobin is not a potential interferent, and to modify the storage conditions to specify refrigeration. None of these changes impact the indications, contraindications, warnings or precautions for the device. Thus, the modified NEPHROCHECK® Test System is substantially equivalent to its predicate.
Conclusions
The modified NEPHROCHECK® Test System is substantially equivalent to the predicate NEPHROCHECK® Test System.