Cleared Traditional

K943279 - ACCUMETER HDL CHOLESTEROL TEST

K943279 is the FDA 510(k) clearance for ACCUMETER HDL CHOLESTEROL TEST by Chemtrak, Inc.. It is a Class 1 Chemistry device (product code LBS) cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K943279 · Chemtrak, Inc. · Chemistry device
Download Printable Device Report (PDF)
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May 1995
Decision
298d
Days
Class 1
Risk

K943279 is an FDA 510(k) clearance for the ACCUMETER HDL CHOLESTEROL TEST. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Chemtrak, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 1, 1995 after a review of 298 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 Chemtrak, Inc. devices

Submission Details

510(k) Number K943279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1994
Decision Date May 01, 1995
Days to Decision 298 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 88d · This submission: 298d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, 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 - LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

All 48
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K943279.
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
K971902 · Roche Diagnostic Systems, Inc. · Jun 1997
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K970735 · Randox Laboratories, Ltd. · Jun 1997
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K963213 · Boehringer Mannheim Corp. · Oct 1996
BECKMAN HDL CHOLESTEROL REAGENT
K934045 · Beckman Instruments, Inc. · Oct 1993
TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL
K914511 · Technicon Instruments Corp. · Nov 1991
IMMUNOTECH HDL-CHOLESTEROL TEST
K900036 · Immunotech Corp. · Mar 1990