ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329

K963934 · Bio-Rad Laboratories, Inc. · MMI · Dec 16, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963934
• Device Name: ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Dec 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The ACCESS® Troponin I assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I levels in human serum, using the ACCESS® Immunoassay System.

Device Story

ACCESS® Troponin I assay is a paramagnetic-particle, chemiluminescent immunoassay used on the ACCESS® Immunoassay System. Input: human serum samples. Principle: two-site 'sandwich' immunoassay using monoclonal antibodies conjugated to alkaline phosphatase and a dioxetane-based chemiluminescent substrate. Output: quantitative cardiac troponin I levels. Used in clinical laboratory settings by trained personnel. Healthcare providers use results to aid in diagnosing acute myocardial infarction (AMI). Benefits: provides diagnostic information for patients with chest pain, including those with confounding conditions like skeletal muscle injury or renal disease.

Clinical Evidence

Multi-site prospective study of 289 subjects with chest pain. 45 subjects confirmed with AMI. Optimal cutoff 0.15 ng/ml yielded 89% clinical sensitivity and 91% clinical specificity. 90% concordance with predicate Stratus® assay (n=201) and 90% concordance with CK-MB (n=208). Specificity in skeletal injury patients (n=58) was 86%; specificity in renal disease patients (n=81) was 96%.

Technological Characteristics

Paramagnetic-particle, chemiluminescent immunoassay. Utilizes monoclonal antibodies and alkaline phosphatase enzyme conjugate. Substrate: dioxetane-based. Form factor: reagent kit for use with ACCESS® Immunoassay System. Detection: chemiluminescence measurement.

Indications for Use

Indicated for the quantitative determination of cardiac troponin I in human serum to aid in the diagnosis of acute myocardial infarction (AMI) in patients presenting with chest pain.

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

• Baxter Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay

Submission Summary (Full Text)

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K963934

# Summary of 510(k) Safety and Effectiveness

## 1. General Information

Device Generic Name: Enzyme Immunoassay, Troponin I
Device Trade Name: ACCESS® Troponin I assay
Applicant's Name and Address: Sanofi Diagnostics Pasteur, Inc.
1000 Lake Hazeltine Drive
Chaska, MN 55318

DEC 16 1996

## 2. Predicate Device

Baxter Stratus® Cardiac Troponin-I Fluorometric Enzyme Immunoassay
Baxter Diagnostics, Inc.
Deerfield, IL 60015-4633

## 3. Device Description

The ACCESS® Troponin I assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I levels in human serum, using the ACCESS® Immunoassay System.

## 4. Comparison of Technological Characteristics

The ACCESS® Troponin I test and the Stratus® Cardiac Troponin-I test are for the measurement of cardiac Troponin I in human serum. Both tests utilize the binding of cardiac Troponin I to specific monoclonal antibodies in a two site "sandwich" immunoassay. Both tests utilize alkaline phosphatase enzyme conjugated to monoclonal antibody.

The ACCESS® Troponin I test uses a dioxetane-based chemiluminescent substrate, while the Stratus® Cardiac Troponin I test uses 4-Methylumberliferyl Phosphate as the substrate. The ACCESS® Troponin I test measures light production from a chemiluminescent reaction while the Stratus® Cardiac Troponin I test measures front surface fluorescence. The ACCESS® Troponin I test uses lyophilized calibrators prepared from buffered human serum matrix with human cardiac troponin I at specified levels, while the Stratus® Cardiac Troponin I test uses liquid calibrators (shipped frozen on dry ice) prepared from buffered bovine protein matrix and human cardiac troponin I at specified levels.

## 5. Summary of Analytical Studies

Precision study: Total imprecision ranges from 5.97% CV (high human serum based control) to 13.53% CV (low human serum based control).

Dilution Recovery: Linearity studies performed by diluting four human serum samples containing Troponin I with Troponin I Diluent gives an average recovery of 93.5%.

Correlation: A comparison of serum Troponin I values from 189 samples run in both the ACCESS® Troponin I assay and the Stratus® Cardiac Troponin I test gives the following statistical data: r = 0.87, y = 0.136x -0.088.

Analytical Sensitivity: The lowest detectable level of troponin I distinguishable from zero (Troponin Calibrator S0) with 95% confidence is 0.03 ng/ml.

## 6. Summary of Clinical Performance

The purpose of this multi-site prospective study was to 1) establish the clinical performance characteristics of the ACCESS® Troponin I assay, and 2) demonstrate substantially equivalent performance to a previously cleared troponin I assay and to the current gold standard biochemical marker, CK-MB.

For this study, 289 subjects presenting to the emergency department with chest pain of 20 minutes duration were followed serially to rule-in or rule-out AMI. Each patient contributed a minimum of two serum samples to establish the diagnosis. Forty five (45) subjects ruled-in for AMIs.

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# Summary of 510(k) Safety and Effectiveness (con't)

ROC curve analysis of all subject results demonstrated an optimal cutoff of 0.15 ng/ml for this clinical indication. Using 0.15 ng/ml as a decision level, the ACCESS® Troponin I assay demonstrated a clinical sensitivity of 89% and a clinical specificity of 91%. Results from 201 patients in which both the ACCESS® Troponin I and the Stratus® Troponin I assays were used, demonstrate 90% concordance. ACCESS® Troponin I assay results were 90% concordant with CK-MB results in 208 subjects tested with both devices.

The sensitivity and specificity of the ACCESS® Troponin I assay was similar to both CK-MB and Stratus® Troponin I when analyzed as a function of time. All assays showed peak sensitivity at 5-11 hours after the onset of chest pain. Both troponin I assays demonstrated peak specificity at 12-23 hours after the onset of chest pain.

ACCESS® Troponin I demonstrated a high degree of specificity in subjects with skeletal muscle injuries and renal disease, two clinical groups that can confound the diagnosis of AMI. The specificity of ACCESS® Troponin I in 58 skeletal injury patients was 86%, which is similar to that of Stratus® Troponin I. For renal disease patients, the specificity of ACCESS® Troponin I assay was 96% for 81 subjects tested.

In conclusion the data demonstrate acceptable diagnostic efficiency of the ACCESS® Troponin I assay reagents when utilized with the ACCESS® Immunoassay Analyzer.

## 7. Conclusion

The ACCESS® Troponin I reagents when utilized with the ACCESS® Immunoassay Analyzer are substantially equivalent to another test currently in commercial distribution for the measurement of cardiac Troponin I.