Cleared Traditional

K943599 - CHEM TRAK ACCUMETER

K943599 is an FDA 510(k) clearance for CHEM TRAK ACCUMETER, manufactured by Chemtrak, Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K943599 · Chemtrak, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
258d
Days
Class 1
Risk

K943599 is an FDA 510(k) clearance for the CHEM TRAK ACCUMETER. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Chemtrak, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 21, 1995 after a review of 258 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - 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 - K943599

510(k) Number K943599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1994
Decision Date March 21, 1995
Days to Decision 258 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
170d slower than avg
Panel avg: 88d · This submission: 258d
Pathway characteristics
Predicate-based equivalence.

CHH Device Classification - Class 1, General Controls

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
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 - CHH Enzymatic Esterase--oxidase, Cholesterol

All 187
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K943599.
DMA TOTAL CHOLESTEROL PROCEDURE
K946161 · Data Medical Associates, Inc. · Aug 1995
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY
K952127 · Boehringer Mannheim Corp. · Jul 1995
PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR
K950164 · Abaxis, Inc. · Apr 1995
TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL
K946063 · Cholestech Corp. · Feb 1995
TOTAL CHOLESTEROL CASSETTE
K946064 · Cholestech Corp. · Feb 1995
TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL
K946065 · Cholestech Corp. · Feb 1995