K Number

Device Name

VIDAS TROPONIN I (TNI), MODEL 30 445

Manufacturer

BIOMERIEUX, INC.

Date Cleared

2003-06-16

(82 days)

Product Code

MMI

Regulation Number

862.1215

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K030950

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard automated immunoassay process with automated data analysis, which is typical for laboratory instruments and does not indicate the use of AI or ML.

Therapeutic

No
The device is an automated quantitative test that determines human cardiac troponin I in serum or plasma. It is used for diagnostic purposes, not for treating any condition.

Diagnostic

Yes
Explanation: The device is used for the "determination of human cardiac troponin 1 in serum or plasma," which is a quantitative test to measure a specific biomarker for diagnostic purposes, specifically in relation to cardiac conditions.

SaMD (Software as a Medical Device)

The device description clearly outlines hardware components like the VIDAS instrument, Solid Phase Receptacle (SPR), and Reagent Strips, which are integral to the assay's function. While software is used for analysis and reporting, the device is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for the "determination of human cardiac troponin 1 in serum or plasma". This indicates that it is used to test samples taken from the human body (in vitro) to provide diagnostic information.
Device Description: The description details a laboratory assay performed on biological samples (serum or plasma) using reagents and an automated instrument. This is characteristic of an in vitro diagnostic test.
Performance Studies: The document includes performance data such as analytical sensitivity, specificity, and correlation with a predicate device, which are standard evaluations for IVD devices.
Predicate Device: The mention of a "Predicate Device(s)" (Stratus CS Cardiac Troponin I Testpak) is a strong indicator that this device is being compared to an existing, legally marketed IVD.

All these elements align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

MMI

Device Description

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.

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

Not Found

Intended User / Care Setting

Not Found

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)

Nonclinical Testing:
Within-run precision: VIDAS TNI % CV 1.3 - 2.5
Dilution % Recovery: VIDAS TNI 97 - 111
Analytical Sensitivity: VIDAS TNI

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.

Summary

JUN 1 6 2003

Image /page/0/Picture/1 description: The image shows a handwritten string of characters, which appears to be an alphanumeric code. The code reads 'K030950'. The characters are written in a clear, legible style, with each digit and letter distinctly formed. The writing is dark and stands out against the background.

510(k) SUMMARY

VIDAS Troponin I (TNI) Assay

A. Submitter Information:

| Submitter's Name:
Address: | bioMérieux, Inc.
595 Anglum Road
Hazelwood, 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 |

----------------------	----------------------------------------------------------

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

Image /page/1/Picture/0 description: The image shows the logo for bioMerieux. The logo consists of the company name in all caps, with a stylized sphere above it. A thin, curved line extends from the top and bottom of the sphere.

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

E. Intended Use:

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.

Image /page/2/Picture/0 description: The image shows the logo for bioMerieux. The logo consists of the company name in all caps, with a stylized circle above it. A curved line bisects the circle and the company name.

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