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K Number
K972094
Device Name
TARGET CARDIAC TROPONIN I TEST
Manufacturer
TEXAS IMMUNOLOGY, INC.
Date Cleared
1997-07-23

(49 days)

Product Code
MMI
Regulation Number
862.1215
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

A rapid enzyme immunoasay test for the quantitative detection of cardiac troponin-I in serum and heparinized plaama as an aid in the diagnosis of acute myocardial infarction. This test is to be used in clinical and hospital laboratories and is not for Doctor's offices use.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for the "Tarqet Cardiac Troponin-I Test." Such letters primarily convey regulatory approval and substantial equivalence findings. They do not typically contain detailed descriptions of acceptance criteria, study designs, sample sizes, or ground truth establishment.

Therefore, the requested information regarding acceptance criteria, study specifics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in the provided document.

The document only states the device's indications for use: "A rapid enzyme immunoassay test for the quantitative detection of cardiac troponin-I in serum and heparinized plasma as an aid in the diagnosis of acute myocardial infarction. This test is to be used in clinical and hospital laboratories and is not for Doctor's offices use."

To obtain the requested information, one would need to consult the original 510(k) submission document (K972094) from Texas Immunology, Inc., which would have included the performance data and study details that the FDA reviewed to make its substantial equivalence determination.

§ 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.