Cleared Traditional

K992665 - MACRA LP(A) ENZYME IMMUNOASSAY KIT

K992665 is the FDA 510(k) clearance for MACRA LP(A) ENZYME IMMUNOASSAY KIT by Trinity Biotech USA. It is a Class 2 Chemistry device (product code DFC) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K992665 · Trinity Biotech USA · Chemistry device
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Nov 1999
Decision
109d
Days
Class 2
Risk

K992665 is an FDA 510(k) clearance for the MACRA LP(A) ENZYME IMMUNOASSAY KIT. Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by Trinity Biotech USA (Jamestown, US). The FDA issued a Cleared decision on November 26, 1999 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5600 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Trinity Biotech USA devices

Submission Details

510(k) Number K992665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1999
Decision Date November 26, 1999
Days to Decision 109 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 88d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFC Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - DFC Lipoprotein, Low-density, Antigen, Antiserum, Control

All 31
Devices cleared under the same product code (DFC) and FDA review panel - the closest regulatory comparables to K992665.
WAKO AUTOKIT LP(A)/EXPRESS 550
K001921 · Wako Chemicals USA, Inc. · Jul 2000
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB
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K001118 · DiaSorin, Inc. · Apr 2000
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
K993669 · DiaSorin, Inc. · Nov 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
K990595 · Roche Diagnostics Corp. · Apr 1999
SPQ TEST SYSTEM
K982708 · DiaSorin, Inc. · Apr 1999