Cleared Traditional

K943279 - ACCUMETER HDL CHOLESTEROL TEST

K943279 is an FDA 510(k) clearance for ACCUMETER HDL CHOLESTEROL TEST, manufactured by Chemtrak, Inc.. The device is a Class 1 Chemistry device with 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)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K943279

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.

LBS Device Classification - Class 1, General Controls

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 72
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K943279.
ACE HDL-C REAGENT
K971526 · Schiapparelli Biosystems, Inc. · May 1997
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K963213 · Boehringer Mannheim Corp. · Oct 1996
CHOLESTECH LDX SYSTEM
K954778 · Cholestech Corp. · Nov 1995
HDL QVET
K943028 · Prisma Systems · Dec 1994
BECKMAN HDL CHOLESTEROL REAGENT
K934045 · Beckman Instruments, Inc. · Oct 1993
TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL
K914511 · Technicon Instruments Corp. · Nov 1991