(414 days)
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No
The description details a standard automated immunoassay system with automated analysis of results, but there is no mention of AI or ML algorithms being used for interpretation or analysis beyond basic calculation and reporting.
No
The device is an in vitro diagnostic test used to aid in the diagnosis of myocardial infarction by measuring cardiac troponin I levels, rather than directly providing therapy.
Yes
The "Intended Use" section explicitly states that the device "is intended to be used as an aid in the diagnosis of myocardial infarction."
No
The device description clearly outlines hardware components like the VIDAS instrument, Solid Phase Receptacle (SPR), and Reagent Strips, indicating it is not a software-only device.
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 VIDAS® Troponin I Ultra is an "automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin I in human serum or plasma...". This clearly indicates that the device is used to test samples taken from the human body (in vitro) to provide diagnostic information.
- Sample Type: The test is performed on "human serum or plasma," which are biological samples taken from a patient.
- Diagnostic Purpose: The intended use also states it is "intended to be used as an aid in the diagnosis of myocardial infarction." This confirms its role in providing information for a medical diagnosis.
- Device Description: The description details how the assay is performed using biological samples and reagents to measure a specific analyte (cardiac troponin I) for diagnostic purposes.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VIDAS Troponin I Ultra (TNIU) 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.
VIDAS® Troponin I Ultra is an automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin I in human serum or plasma (lithium heparin) using the ELFA (Enzymc-Linked Fluorescent Assay) technique. VIDAS Troponin I Ultra is intended to be used as an aid in the diagnosis of myocardial infarction.
Product codes (comma separated list FDA assigned to the subject device)
MMI
Device Description
The VIDAS Troponin I Ultra (TNIU) 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 TNIU 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 anticardiac 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 TNIU 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing:
Expected Values: 99% of 747 patients with no cardiac symptoms had values of
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for BIOMÉRIEUX. The logo consists of a stylized globe with vertical lines on the left half and a solid black right half. The company name, "BIOMÉRIEUX", is printed in a stylized font below the globe.
DEC 1 4 2007
510(k) SUMMARY
VIDAS® Troponin | Ultra (TNIU) Assay
A. Submitter Information
| Submitter's Name:
Address: | bioMérieux, Inc.
595 Anglum Road
Hazelwood, MO 63042 |
|-------------------------------|------------------------------------------------------------|
| Contact Person: | Nikita S. Mapp |
| Phone Number: | 314-731-7474 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | August 11, 2006 |
B. Device Name
| Trade Name: | VIDAS® Troponin I Ultra (TNIU) Assay |
|---|---|
| Common Name: | Troponin I Enzyme Immunoassay |
| Classification Name: | 21 CFR 862.1215, Product Code MMI |
| Immunoassay method, Troponin Subunit |
C. Predicate Device Name
| Trade Name: | Dimension RxL® Cardiac Troponin I (CTNI) Assay |
|---|---|
| ------------- | ------------------------------------------------ |
D. Device Description
The VIDAS Troponin I Ultra (TNIU) 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 TNIU 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 anticardiac troponin i immunoglobulin coating the interior of the SPR. Unbound sample components are washed away.
1
Image /page/1/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a stylized globe split vertically, with one half shaded with vertical lines and the other half solid black. Below the globe, the company name "bioMérieux" is written in a stylized font with spaces between the letters.
A fluorescent substrate, 4-methylumbellifery| 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 TNIU assay is completed, the results are analyzed automatically by the computer, a test value is generated, and a report is printed for each sample.
E. Intended Use
VIDAS Troponin I Ultra (TNIU) 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.
| Similarities | ||
|---|---|---|
| Item | VIDAS® TNIU | Dimension RxL® CTNI |
| Assay Principle | One-step automated immunoassay based on | |
| sandwich principle | Same | |
| Intended Use | Quantitative determination of human cardiac | |
| troponin I in human serum or plasma (lithium | ||
| heparinate) | Same | |
| Indications for Use | An aid in the diagnosis of mycocardial infarction | Same |
| Sample Type | Human serum or plasma (lithium heparin) | Same |
| Antibody | Capture: mouse monoclonal antibody | |
| Conjugate: mouse monoclonal antibody | ||
| labeled with alkaline phosphatase | Same |
F. Technological Characteristics Summary
| Differences | ||
|---|---|---|
| Item | VIDAS® TNIU | Dimension RxL® CTNI |
| Solid Phase | Solid Phase Receptacle (SPR) | Chrome |
| Final Detection of | ||
| troponin-I antigen | Fluorescence (ELFA) of 4-methyl- | |
| umbelliferyl measured at 450 nm | Colorimetric rate measurement at 510 | |
| nm | ||
| Measurement range | 0.01 to 30 µg/L | 0.04 to 40 µg/L |
| Analytical Detection Limit | 0.01 µg/L | 0.04 µg/L |
| Hook effect | No hook effect found up to | |
| concentrations of 1000 µg/L | No hook effect found up to | |
| concentrations of 1800 µg/L | ||
| Sample Volume | 200 µl | 50 µl |
| Assay Time | ~20 minutes | ~17 minutes |
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Image /page/2/Picture/0 description: The image shows the logo for bioMerieux. The logo consists of a circle that is half black and half white with lines. Below the circle is the name of the company, "bioMerieux".
G. Performance Data
Nonclinical Testing
| Dimension® RxL CTNI | VIDAS® TNIU | |
|---|---|---|
| Expected Values | 97.5% of 101 apparently | |
| healthy patients had values | ||
| of 0.00 -0.05 µg/L | 99% of 747 patients with no | |
| cardiac symptoms had | ||
| values of |