VIDAS Troponin I Assay is an automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin 1 in serum or plasma (lithium heparinate) using the ELFA (Enzyme-Linked Fluorescent Assay) technique

Device Description

The VIDAS Troponin I (TNI) Assay is an enzyme-linked fluorescent immunoassay (ELFA) performed in an automated VIDAS® instrument. All assay steps and assay temperature are controlled by the instrument. A pipette tip-like disposable device, the Solid Phase Receptacle (SPR), serves as the solid phase as well as a pipettor for the assay. Reagents for the assay are in the sealed TNI Reagent Strips.

The sample is transferred into the wells containing anti-cardiac troponin I antibodies labeled with alkaline phosphatase (conjugate). The sample/conjugate mixture is cycled in and out of the SPR for a specified length of time. Troponin I present in the specimen will bind to the anti-cardiac troponin I immunoglobulin coating the interior of the SPR. Unbound sample components are washed away.

A fluorescent substrate, 4-methylumbelliferyl phosphate, is introduced into the SPR. Enzyme remaining on the SPR wall will catalyze the conversion of the substrate to the fluorescent product 4-methylumbelliferone. The optical scanner in the instrument measures the intensity of fluorescence. When the VIDAS TNI assay is completed, the results are analyzed automatically by the computer, a test value is generated, and a report is printed for each sample.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the VIDAS Troponin I (TNI) Assay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined column. Instead, it presents performance data for both the VIDAS TNI assay and its predicate device, the Stratus CS Cardiac Troponin I Testpak, implying that the VIDAS TNI assay needed to demonstrate comparable performance to the predicate. The "Reported Device Performance" column reflects the performance of the VIDAS TNI assay.

Performance Characteristic	Predicate Device (SCS cTnl) Performance	VIDAS TNI Assay Performance
Nonclinical Testing
Within-run precision (% CV)	2.7 - 4.3	1.3 - 2.5
Dilution % Recovery	98.1 - 102.0	97 - 111
Analytical Sensitivity	0.03 µg/l	< 0.01 µg/l
Expected Values	95% of 101 apparently healthy patients had values of 0.00 - 0.06 µg/l	99.4% of 496 clinically healthy patients had values below 0.1 µg/l
Interference - Bilirubin	No significant interference from: 1026 µmol/L	No significant interference from: 491 µmol/L
Interference - Hemoglobin	No significant interference from: 1000 mg/dL	No significant interference from: 300 µmol/L
Interference - Triglycerides	No significant interference from: 3000 mg/dL	No significant interference from: 30 mg/ml
Specificity - Troponin-C	1000 µg/l: 0.01%	1000 µg/l: < 0.001%
Specificity - Cardiac Troponin T	1000 µg/l: 0.04%	60 µg/l: 1.6%
Specificity - Skeletal Muscle Troponin T	1000 µg/l: 0.04%	1000 µg/l: < 0.001%
Specificity - Skeletal Muscle Troponin I	280 µg/l: 0.04%	1000 µg/l: < 0.001%
Clinical Testing
Plasma Sample Correlation (vs. predicate)	N/A (Pred: X)	Y = 1.016 X = 0.013, r = 0.92
Serum Sample Correlation (vs. predicate)	N/A (Pred: SCS Cardiac Troponin I)	VIDAS TNI = 7.33 SCS Cardiac Troponin I, r = 0.92

2. Sample Size Used for the Test Set and Data Provenance:

Plasma samples: 107 samples.
Serum samples: 32 samples.
Provenance: Not explicitly stated. The document refers to "apparently healthy patients" and "clinically healthy patients" for expected values, but no geographical origin or retrospective/prospective nature is specified for the clinical correlation studies. This suggests that these samples were likely collected for the purpose of the study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement of a biomarker. The "ground truth" for the test set is established by the values obtained from the predicate device (SCS Cardiac Troponin I) and direct analytical measurements (e.g., for precision, sensitivity, interference). Expert judgment in the way it's used for image-based diagnostics with human interpretation is not relevant here.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is an IVD device. The comparison is between the quantitative results of the new device and the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is an IVD test, not an AI-assisted diagnostic device that involves human readers interpreting results.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device itself is an automated instrument performing an Enzyme-Linked Fluorescent Immunoassay (ELFA). Its performance is inherently "standalone" in the sense that the instrument performs all assay steps and analysis automatically, generating a test value for each sample. There is no human-in-the-loop interpretation or intervention in the generation of the quantitative result.

7. The Type of Ground Truth Used:

Clinical Testing (Correlation): The "ground truth" for the clinical correlation studies was the result obtained from the predicate device, the Stratus CS Cardiac Troponin I Testpak. The study compared the VIDAS TNI results directly to those of the predicate.
Nonclinical Testing (Analytical Performance): For analytical performance characteristics like precision, sensitivity, dilution recovery, and interference, the ground truth is established through controlled laboratory experiments and reference materials/methods (e.g., known concentrations for sensitivity and recovery, spiked samples for interference). For "Expected Values," the ground truth was observational data from a cohort of apparently/clinically healthy individuals.

8. The Sample Size for the Training Set:

Not explicitly stated. This document describes a 510(k) submission, which focuses on demonstrating substantial equivalence, primarily through verification and validation testing, rather than explicit "training set" size for a machine learning model. For an IVD device like this, the development likely involved:

Pre-clinical testing to optimize reagents and assay parameters (which could be considered analogous to training/optimization).
Clinical validation studies for the 510(k) submission.

The reported sample sizes (107 plasma, 32 serum, 496 healthy patients, 101 healthy patients) are those used for the validation/test phase presented in the submission.

9. How the Ground Truth for the Training Set Was Established:

Not explicitly stated. Given that this is an immunoassay, the "training" phase would involve traditional assay development and optimization (e.g., optimizing antibody concentrations, incubation times, wash steps) using characterized samples or reference materials. The "ground truth" during this development would be based on established analytical chemistry principles, known concentrations of analytes, and comparisons to existing reference methods or the performance targets of an already existing predicate device.

Summary

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JUN 1 6 2003

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510(k) SUMMARY

VIDAS Troponin I (TNI) Assay

A. Submitter Information:

Submitter's Name:Address:	bioMérieux, Inc.595 Anglum RoadHazelwood, MO 63042
Contact Person:	Nancy Weaver
Phone Number:	314-731-8695
Fax Number:	314-731-8689
Date of Preparation:	January 17, 2003
B. Device Name:
Trade Name:	VIDAS Troponin I (TNI) Assay
Common Name:	Enzyme-linked Fluorescent Immunoassay (ELFA) for

the quantitative detection of human cardiac troponin I.

Classification Name:	21 CFR 862.1215,Immunoassay method, Troponin Subunit
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C. Predicate Device Name:

Trade Name: Stratus CS Cardiac Troponin I Testpak

D. Device Description:

bioMérieux, Inc.

595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700 http://www.biomerieux-usa.com

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bind to the anti-cardiac troponin I immunoglobulin coating the interior of the SPR. Unbound sample components are washed away.

E. Intended Use:

VIDAS Troponin I Assay is an automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin I in serum or plasma (lithium heparinate) using the ELFA (Enzyme-Linked Fluorescent Assay) technique.

F. Technological Characteristics Summary:

Major Similarities Include:

1. Both tests are run on automated immunoassay systems.
1. Both assays are quantitative tests for the detection of cardiac troponin I in human plasma. The VIDAS assay can also be used with serum.
1. Both test use reagent test strips or packs.
1. Both tests use mouse monoclonal antibodies for antigen capture and in the coniugate.
1. Both assays use 4-methylumbelliferyl phosphate as a fluorescent substrate.

Major Differences Include:

1. The VIDAS TNI assay is a one-step immunoassay sandwich method.
  The SCS cTnl assay is two-site sandwich assay based on solid phase Radial Partition Immunoassay technology.
1. The VIDAS TNI assay uses a Solid Phase Receptacle (SPR) to capture the antigen.
  The SCS cTnl assay uses glass fiber paper to capture the antigen.

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G. Performance Data:

Nonclinical Testing:

	SCS cTnl	VIDAS TNI
Within-run precision:% CV	2.7 - 4.3	1.3 - 2.5
Dilution % Recovery	98.1 - 102.0	97 - 111
Analytical Sensitivity:	0.03 µg/l	< 0.01 µg/l
Expected Values	95% of 101 apparently healthypatients had values of 0.00 -0.06 µg/l	99.4% of 496 clinically healthypatients had values below 0.1µg/l
Interference	No significant interference from:Bilirubin 1026 µmol/LHemoglobin 1000 mg/dLTriglycerides 3000 mg/dL	No significant interference from:Bilirubin 491 µmol/LHemoglobin 300 µmol/LTriglycerides 30 mg/ml
Specificity:	Troponin-C (cardiac)1000 µg/l:0.01%	Troponin C1000 µg/l:< 0.001%
	Troponin-T (cardiac)1000 µg/l:0.04%	Cardiac Troponin T60 µg/l:1.6%
	Troponin-T (skeletal)1000 µg/l:0.04%	Skeletal Muscle Troponin T1000 µg/l:< 0.001%
	Troponin-l (skeletal)280 µg/l:0.04%	Skeletal Muscle Troponin I1000 µg/l:< 0.001%

Clinical Testing:

One hundred and seven plasma samples were tested with both the VIDAS TNI (Y) and the SCS Cardiac Troponin I (X). The results are as follows: Y = 1.016 X = 0.013 with a correlation coefficient of 0.92.

Thirty-two serum samples were tested with both the VIDAS TNI and the SCS Cardiac Troponin I assay. The results are as follows: VIDAS TNI = 7.33 SCS Cardiac Troponin I Correlation coefficient = 0.92

H. Conclusion:

The VIDAS Troponin I (TNI) Assay is substantially equivalent to the Stratus CS Cardiac Troponin I Testpak.

bioMérieux, Inc.

595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700 http://www.biomerieux-usa.com

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JUN 1 6 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nancy Weaver Staff Regulatory Specialist BioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320

Re: K030950

Trade/Device Name: VIDAS Troponin I Assay Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: March 12, 2003 Received: March 26, 2003

Dear Ms. Weaver:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: VIDAS Troponin I Assay

Indications for Use:

Sean Cooley

Division Sign-Off

Óffice of In Vitro Diagnostic Device Evaluation and Safety

510(k) K030950

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.

(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.