(479 days)
Not Found
No
The device performs a standard immunoassay and calculates a score based on a simple mathematical formula ([TIMP-2] x [IGFBP-7]) / 1000. There is no mention of AI or ML in the description of the technology or the calculation method.
No.
The device is an in-vitro diagnostic test that aids in the risk assessment for acute kidney injury; it does not provide therapy.
Yes
This device is used for the "immunoenzymatic quantitative determination" of specific proteins in human urine to calculate an "AKIRISK™ Score," which serves as an "aid in the risk assessment for moderate or severe acute kidney injury (AKI)." This function directly supports the diagnosis or risk assessment of a medical condition.
No
The device description clearly outlines physical components (reagent strips, solid phase receptacles, controls, calibrators) and a chemical/biological assay technique (ELFA) performed on a specific instrument (VIDAS® 3). While the instrument performs calculations, the core of the device involves physical reagents and a chemical reaction, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "immunoenzymatic quantitative determination of TIMP-2 and IGFBP-7 proteins in human urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body).
- Device Description: The description details the components of the kit (reagent strips, solid phase receptacles, control, calibrator) and the assay principle (ELFA technique) which are typical of laboratory-based diagnostic tests performed on biological samples.
- Performance Studies: The document includes summaries of analytical and clinical performance studies, which are required for IVD devices to demonstrate their accuracy and reliability in a laboratory setting.
- Predicate Device: The mention of a predicate device (NEPHROCHECK Test Kit) with a K number (K171482) indicates that this device is being compared to a previously cleared IVD device.
All these points strongly support the classification of the VIDAS® NEPHROCHECK® as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VIDAS® NEPHROCHECK® is an automated test for use on the VIDAS® 3 instrument for the immunoenzymatic quantitative determination of TIMP-2 (Tissue Inhibitor of Metalloproteinase-2) and IGFBP-7 (Insulin-like Growth Factor-Binding Protein 7) proteins in human urine using the ELFA technique (Enzyme Linked Fluorescent Assay) for calculation of the AKIRISKTM Score.
The VIDAS® NEPHROCHECK® assay 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 VIDAS® NEPHROCHECK® test 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
Each VIDAS® NEPHROCHECK® kit contains: x60 NEPH Reagent Strips, x60 NEPH Solid Phase Receptacles (SPR), 1 NEPH control and 1 NEPH calibrator. The VIDAS® NEPHROCHECK® principle combines an enzyme immunoassay competition method with a final fluorescent detection (ELFA).
The Solid Phase Receptacle (SPR®) serves as the solid phase as well as the pipetting device for the assay. The interior of the NEPH SPR is coated with mouse monoclonal lgG anti-IGFBP-7 andanti-TIMP-2.
The Reagent Strips consist of 10 wells covered with a labeled foil seal. Well 1 is designated for the sample. Six of the wells contain conjugate, wash buffers and substrate. Last well contains the fluorescence substrate.
All of the assay steps are performed automatically by the instrument.
Two detection steps, one for each protein, are performed successively in Well 10.
· The first step is a classical detection step with measurement of the substrate background and incubation of the substrate in the bottom of the SPR®, to generate the first fluorescent signal, which is specific for the IGFBP-7 protein.
· Before the second detection step, the antibodies and proteins in the bottom of the SPR® are removed using the cleaning solution contained in Well 5. The previously used substrate in Well 10 is removed and replaced by fresh substrate contained in Well 9. A new substrate background is then measured, and the substrate is incubated in the top of the SPR® to generate the second fluorescent signal, which is specific for the TIMP-2 protein.
For each protein, the intensity of the fluorescence is proportional to its concentration in the sample. At the end of the test, the protein concentrations are calculated by the instrument in relation to the two calibration curves, one corresponding to each protein, and encoded in the MLE data.
The instrument calculates the AKIRISK™ Score, which is defined as the product of the concentrations of the two proteins, expressed in ng/mL, divided by 1000:
AKIRISK™ Score = ([TIMP-2] x [IGFBP-7]) / 1000
The result of the VIDAS® NEPHROCHECK® assay is reported as the AKIRISK™ Score.
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
patients 21 years of age or older.
Intended User / Care Setting
ICU patients
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)
Analytical specificity:
The study was performed as recommended by CLSI® document EP7-Ed3 "Interference Testing in Clinical Chemistry, 3rd Edition".
The study has been carried out on different lots of VIDAS® NEPHROCHECK® assay tested on the VIDAS® 3 instrument.
Interferences: The measurement procedure for VIDAS® NEPHROCHECK® was found not to interfere from any of the potentially interfering substances except with Phosphate up to 1100 mq/L, with Albumin up to 6900 mg/L and with Hemoglobin up to the concentration of 60 mg/L.
Cross-reactivity of structurally related molecules: All of the potentially cross-reactant substances tested were found not to interfere with the measurement of VIDAS® NEPHROCHECK® assay.
Detection and quantitation limits:
The study was performed as recommended by CLSI® document EP17-A2 "Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures, 2nd Edition".
The claimed Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ ) for the VIDAS® NEPHROCHECK® assay on the VIDAS 3 instrument are: LoB = 0.002, LoD = 0.003, LoQ = 0.003 for AKIRISKTM SCORE.
The study supports the following requirement: LoB
§ 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 8, 2022
bioMérieux SA Julien Thao My Regulatory Affairs Specialist 376 Chemin de l'Orme Marcy l'Etoile, 69280 France
Re: K210793
Trade/Device Name: VIDAS® NEPHROCHECK® Regulation Number: 21 CFR 862.1220 Regulation Name: Acute Kidney Injury Test System Regulatory Class: Class II Product Code: PIG Dated: March 3, 2022 Received: March 7, 2022
Dear Julien Thao My:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiologial Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210793
Device Name VIDAS® NEPHROCHECK®
Indications for Use (Describe)
VIDAS® NEPHROCHECK® is an automated test for use on the VIDAS® 3 instrument for the immunoenzymatic quantitative determination of TIMP-2 (Tissue Inhibitor of Metalloproteinase-2) and IGFBP-7 (Insulin-like Growth Factor-Binding Protein 7) proteins in human urine using the ELFA technique (Enzyme Linked Fluorescent Assay) for calculation of the AKIRISKTM Score.
The VIDAS® NEPHROCHECK® assay 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 VIDAS® NEPHROCHECK® test is intended to be used in patients 21 years of age or older.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirement of Safe Medical Devices Act of 1990 and 21 CFR 807.92.
K210793 - VIDAS® NEPHROCHECK®
A. Submitter Information
| Submitter's Name: | bioMérieux SA |
|---|---|
| Address: | 376 Chemin de l'Orme, 69280 Marcy-l'Étoile, France |
| Contact Person: | Julien THAO MY |
| Phone Number: | +33 4 78 87 70 64 |
| Fax Number: | +33 4 78 87 76 65 |
| Date of Preparation: | 15 March 2021 |
B. Device Name
| Trade Name: | VIDAS® NEPHROCHECK® |
|---|---|
| Common Name | VIDAS NEPH |
| Classification Name: | Acute Kidney Injury test system (21 CFR 862.1220, |
| Product Code PIG) - Class 2 in vitro Diagnostic device |
C. Predicate Device Name
Trade Name: NEPHROCHECK Test Kit, Astute Medical, Inc., K171482
D. Device Description
Each VIDAS® NEPHROCHECK® kit contains: x60 NEPH Reagent Strips, x60 NEPH Solid Phase Receptacles (SPR), 1 NEPH control and 1 NEPH calibrator. The VIDAS® NEPHROCHECK® principle combines an enzyme immunoassay competition method with a final fluorescent detection (ELFA).
The Solid Phase Receptacle (SPR®) serves as the solid phase as well as the pipetting device for the assay. The interior of the NEPH SPR is coated with mouse monoclonal lgG anti-IGFBP-7 andanti-TIMP-2.
4
The Reagent Strips consist of 10 wells covered with a labeled foil seal. Well 1 is designated for the sample. Six of the wells contain conjugate, wash buffers and substrate. Last well contains the fluorescence substrate.
All of the assay steps are performed automatically by the instrument.
Two detection steps, one for each protein, are performed successively in Well 10.
· The first step is a classical detection step with measurement of the substrate background and incubation of the substrate in the bottom of the SPR®, to generate the first fluorescent signal, which is specific for the IGFBP-7 protein.
· Before the second detection step, the antibodies and proteins in the bottom of the SPR® are removed using the cleaning solution contained in Well 5. The previously used substrate in Well 10 is removed and replaced by fresh substrate contained in Well 9. A new substrate background is then measured, and the substrate is incubated in the top of the SPR® to generate the second fluorescent signal, which is specific for the TIMP-2 protein.
For each protein, the intensity of the fluorescence is proportional to its concentration in the sample. At the end of the test, the protein concentrations are calculated by the instrument in relation to the two calibration curves, one corresponding to each protein, and encoded in the MLE data.
The instrument calculates the AKIRISK™ Score, which is defined as the product of the concentrations of the two proteins, expressed in ng/mL, divided by 1000:
AKIRISK™ Score = ([TIMP-2] x [IGFBP-7]) / 1000
The result of the VIDAS® NEPHROCHECK® assay is reported as the AKIRISK™ Score.
E. Intended Use
VIDAS® NEPHROCHECK® is an automated test for use on the VIDAS® 3 instrument for the immunoenzymatic quantitative determination of TIMP-2 (Tissue Inhibitor of Metalloproteinase-2) and IGFBP-7 (Insulin-like Growth Factor-Binding Protein 7) proteins in human urine using the ELFA technique (Enzyme Linked Fluorescent Assay) for calculation of the AKIRISKTM Score.
The VIDAS® NEPHROCHECK® assay 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 VIDAS® NEPHROCHECK® test is intended to be used in patients 21 years of age or older.
5
F. Technological Characteristics Summary
A general comparison of the similarities and differences of the assays with the predicate is presented in the table below.
| Item | VIDAS® NEPHROCHECK® assay | Astute Medical NEPHROCHECK Test
Kit |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | VIDAS® NEPHROCHECK® is an automated
test for use on the VIDAS® 3 instrument for
the immunoenzymatic quantitative
determination of TIMP-2 (Tissue Inhibitor of
Metalloproteinase-2) and IGFBP-7 (Insulin-
like Growth Factor-Binding Protein 7)
proteins in human urine using the ELFA
technique (Enzyme Linked Fluorescent
Assay).
The VIDAS® NEPHROCHECK® assay 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 VIDAS®
NEPHROCHECK® test is intended to be
used in patients 21 years of age or older. | 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. |
| Specimen | Urine | Urine |
| Analyte | TIMP-2
IGFBP-7 | TIMP-2
IGFBP-7 |
| Automated | Yes | Yes |
| Assay
Technique | Enzyme-linked fluorescent assay
(ELFA) | Lateral flow with fluorescent
detection |
| Assay
principle | Labeled antibody competition method | Same |
G. Nonclinical Testing
A summary of the performance results is presented below.
Analytical specificity
The study was performed as recommended by CLSI® document EP7-Ed3 "Interference Testing in Clinical Chemistry, 3rd Edition".
The study has been carried out on different lots of VIDAS® NEPHROCHECK® assay tested on the VIDAS® 3 instrument.
6
Interferences:
The measurement procedure for VIDAS® NEPHROCHECK® was found not to interfere from any of the potentially interfering substances except with Phosphate up to 1100 mq/L, with Albumin up to 6900 mg/L and with Hemoglobin up to the concentration of 60 mg/L.
Cross-reactivity of structurally related molecules:
All of the potentially cross-reactant substances tested were found not to interfere with the measurement of VIDAS® NEPHROCHECK® assay.
Detection and quantitation limits
The study was performed as recommended by CLSI® document EP17-A2 "Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures, 2nd Edition".
The claimed Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ ) for the VIDAS® NEPHROCHECK® assay on the VIDAS 3 instrument
| | AKIRISKTM
SCORE |
|-----|--------------------|
| LoB | 0.002 |
| LoD | 0.003 |
| LoQ | 0.003 |
The study supports the following requirement:
- . LoB