Cleared Traditional

K962723 - TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN

K962723 is an FDA 510(k) clearance for TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN, manufactured by Trace America, Inc.. The device is a Class 1 Chemistry device with product code LBR cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K962723 · Trace America, Inc. · Chemistry device
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Mar 1997
Decision
241d
Days
Class 1
Risk

K962723 is an FDA 510(k) clearance for the TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on March 13, 1997 after a review of 241 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 Trace America, Inc. devices

FDA 510(k) Submission Details - K962723

510(k) Number K962723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1996
Decision Date March 13, 1997
Days to Decision 241 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 88d · This submission: 241d
Pathway characteristics
Predicate-based equivalence.

LBR Device Classification - Class 1, General Controls

Product Code LBR Ldl & Vldl Precipitation, Hdl
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LBR Ldl & Vldl Precipitation, Hdl

All 53
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K962723.
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
K974733 · Boehringer Mannheim Corp. · Jan 1998
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
K973369 · Roche Diagnostic Systems, Inc. · Nov 1997
N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
K971573 · Genzyme Corp. · Jun 1997
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
K962186 · Genzyme Corp. · Aug 1996
HDL PRECIPITATING REAGENT
K954179 · Schiapparelli Biosystems, Inc. · Dec 1995
MAGNETIC HDL CHOLESTEROL TEST
K944975 · Reference Diagnostics, Inc. · Aug 1995