STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY

K965213 · Dade Intl., Inc. · DDR · Feb 10, 1997 · Immunology

Device Facts

• Record ID: K965213
• Device Name: STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY
• Applicant: Dade Intl., Inc.
• Product Code: DDR · Immunology
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5680
• Device Class: Class 2

Indications for Use

The Stratus® Myoglobin Fluorometric Enzyme Immunoassay is an in vitro diagnostic test for the quantitative measurement of myoglobin in human serum and heparinized plasma. Myoglobin measurements are used in the diagnosis and treatment of myocardial infarction.

Device Story

Fluorometric enzyme immunoassay for quantitative myoglobin measurement in human serum and heparinized plasma; used to aid myocardial infarction diagnosis. Device utilizes Stratus® system platform. Modification from predicate (K922125/A) involves addition of heparinized plasma as validated sample type. Clinicians use results to assess cardiac injury. Testing performed in laboratory setting.

Clinical Evidence

Bench testing only. Comparative performance study analyzed 101 patient samples in duplicate (serum vs. heparinized plasma). Results: correlation coefficient 0.98; regression equation y = 0.94x + 7.09. Performance deemed acceptable.

Technological Characteristics

Fluorometric enzyme immunoassay; quantitative measurement; compatible with Stratus® system instrumentation. Sample types: serum and heparinized plasma.

Indications for Use

Indicated for the quantitative measurement of myoglobin in human serum and heparinized plasma to aid in the diagnosis and treatment of myocardial infarction.

Regulatory Classification

Identification

A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

Predicate Devices

• Stratus® Myoglobin Fluorometric Enzyme Immunoassay (K922125/A)

Submission Summary (Full Text)

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K965213 FEB 10 1997

# 510(k) Summary of Safety and Effectiveness Information
## Stratus® Myoglobin Fluorometric Enzyme Immunoassay
### December 27, 1996

Dade International Inc.
2173 N.W. 99th Avenue
Miami, FL 33172
Contact Person: Radha Goolabsingh at 305-392-5621 or Radames Riesgo at 305-5615, or by facsimile at 305-392-5622.

**Trade or Proprietary Name:** Stratus® Myoglobin Fluorometric Enzyme Immunoassay
**Common or Usual Name:** Myoglobin immunological test system
**Classification Name:** None
**Registration Number:** *Manufacturer*

Dade International Inc.
2173 N.W. 99th Avenue
Miami, FL 33172 1025506
(formerly at 9750 N.W. 25 Street, Miami, FL 33172)

Dade International Inc.
1851 Delaware Parkway
Miami, Florida 33125 1017272

The proposed Stratus® Myoglobin Fluorometric Enzyme Immunoassay is substantially equivalent in intended use and technological characteristics to the current Stratus® Myoglobin Fluorometric Enzyme Immunoassay, manufactured by Dade International Inc., Miami, FL, previously cleared under Document Control No., K922125/A. The proposed device is being modified to include heparinized plasma as a sample type.

During an in-house comparative performance study, 101 patient samples were analyzed in duplicate for both serum and heparinized plasma samples using the Stratus® Myoglobin Assay procedure. The correlation coefficient was calculated at 0.98 and the regression equation was $$y = 0.94x + 7.09$$, where $$y =$$ plasma samples. The correlation coefficient and the regression equation were found to be acceptable.

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