CARDIAC T TROPONIN T RAPID ASSAY

K964372 · Boehringer Mannheim Corp. · MMI · Feb 10, 1997 · Clinical Chemistry

Device Facts

• Record ID: K964372
• Device Name: CARDIAC T TROPONIN T RAPID ASSAY
• Applicant: Boehringer Mannheim Corp.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The CARDIAC T Rapid Assay is intended for the qualitative determination of cardiac troponin T in anticoagulated venous or arterial whole blood. The measurement of cardiac troponin T has been shown to aid in the diagnosis of acute myocardial infarction (injury).

Device Story

The CARDIAC T® Troponin T Rapid Assay is a qualitative diagnostic test for cardiac troponin T. It utilizes a dual monoclonal antibody sandwich principle with a poly(streptavidin)-biotin capture system and gold sol particle label. The user applies whole blood (130-160 μL) to the device, which separates red blood cells from plasma. The assay provides a qualitative result within 15-30 minutes. It is intended for use by healthcare professionals to aid in the diagnosis of acute myocardial infarction. The device output is a visual qualitative determination based on a cut-off of ≥ 0.08 ng/mL, which informs clinical decision-making regarding potential cardiac injury.

Clinical Evidence

Bench testing only. Method comparison performed on 335 individual patient samples comparing the 2nd generation assay to the 1st generation predicate, demonstrating agreement in 156 of 179 cases. Interference testing evaluated hemolysis, icterus, biotin, Intralipid, and 31 common pharmaceutical compounds, showing no interference at tested levels.

Technological Characteristics

Dual monoclonal antibody sandwich immunoassay; poly(streptavidin)-biotin capture system; gold sol particle label. Sample volume 130-160 μL. Cut-off ≥ 0.08 ng/mL. Read time 15-30 minutes. Compatible with EDTA or Heparin anticoagulated whole blood.

Indications for Use

Indicated for qualitative determination of cardiac troponin T in anticoagulated venous or arterial whole blood to aid in the diagnosis of acute myocardial infarction.

Regulatory Classification

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.

Predicate Devices

• CARDIAC T® Troponin T Rapid Assay (K964372)

Submission Summary (Full Text)

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K964372
FEB 10 1997

# 510(k) Summary CARDIAC T® Troponin T Rapid Assay Modification

Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

1) Submitter name, address, contact
Boehringer Mannheim Corporation
9115 Hague Rd.
Indianapolis, IN 46250
[phone]

Contact Person: John D. Stevens
Date Prepared: October 29, 1996

2) Device name
Proprietary name: CARDIAC T® Troponin T Rapid Assay

Common name: troponin test

Classification name: Immunoassay method, troponin subunit

3) Predicate device
We claim substantial equivalence to the currently marketed CARDIAC T® Troponin T Rapid Assay.

4) Device Description
The CARDIAC T® Troponin T Rapid Assay (2nd generation) test principle is based on the dual monoclonal antibody “sandwich” principle using a poly(streptavidan)-biotin capture system with a gold sol particle label. The test is initiated by the addition of whole blood to the CARDIAC T Rapid Assay, which separates red blood cells from plasma.

5) Intended use
The CARDIAC T Rapid Assay is intended for the qualitative determination of cardiac troponin T in anticoagulated venous or arterial whole blood. The measurement of cardiac troponin T has been shown to aid in the diagnosis of acute myocardial infarction (injury).

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# 510(k) Summary, CARDIAC T® Troponin T Rapid Assay Modification, Continued

## 6) Comparison to predicate device

The Boehringer Mannheim CARDIAC T® Troponin T Rapid Assay (2nd generation) is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed CARDIAC T® Troponin T Rapid Assay.

The following table compares the CARDIAC T® Troponin T Rapid Assay (2nd generation) with the predicate device, CARDIAC T® Troponin T Rapid Assay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device is provided in attachment 6.

### Similarities:

| Feature | 2nd generation Rapid Assay | 1st generation Rapid Assay |
| --- | --- | --- |
| Intended use | Aid in the diagnosis of acute myocardial infarction (injury) | Same |
| Sample type | Whole blood containing EDTA or Heparin | Same |
| Sample volume | 130 - 160 μL | Same |
| Reaction test principle | Dual monoclonal antibody “sandwich” principle | Same |

### Differences:

| Feature | 2nd generation Rapid Assay | 1st generation Rapid Assay |
| --- | --- | --- |
| antibodies | MAK M11-7 and MAK M-7 | MAK 1B10 and MAK M-7 |
| Cut - off | ≥ 0.08 ng/mL | ≥ 0.20 ng/mL |
| Read time | 15 - 30 minutes | 20 - 45 minutes |

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# 510(k) Summary, CARDIAC T® Troponin T Rapid Assay Modification, Continued

## 6) Comparison to predicate device, (cont.)

### Performance Characteristics:

| Feature | 2nd generation Rapid Assay | 1st generation Rapid Assay |
| --- | --- | --- |
| Cut-off | ≥0.08 ng/mL | ≥0.20 ng/mL |
| Method Comparison | 335 individual patient results were compared between the the assays demonstrating agreement in 156 of 179 cases | |
| Interfering substances | Evaluated for hemolysis, icterus, biotin, Intralipid and 31 common pharmaceutical compounds. No interference at the levels tested | Evaluated for interference from hemolysis, icterus, biotin, Intralipid and 31 common pharmaceutical compounds. No interference at the levels tested |