Cleared Traditional

CHEMTRAK ACCUMETER CHOLESTEROL TEST (K905405) - FDA 510(k) Clearance

Class I Chemistry device.

K905405 · Chemtrak, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Mar 1991
Decision
106d
Days
Class 1
Risk

K905405 is an FDA 510(k) clearance for the CHEMTRAK ACCUMETER CHOLESTEROL TEST. 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 19, 1991 after a review of 106 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K905405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1990
Decision Date March 19, 1991
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 88d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 229
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K905405.
Lipids
K251091 · Truvian Health · Dec 2025
CHOLESTEROL
K232404 · Medicon Hellas S.A · Aug 2024
Cholesterol2
K203597 · Abbott Ireland Diagnostics Division · Jun 2022
VITROS XT Chemistry Products TRIG-CHOL Slides
K190490 · Ortho-Clinical Diagnostics, Inc. · Mar 2019
Extended Lipid Panel Assay
K181373 · Laboratory Corporation of America Holdings · Oct 2018
Mission Lipid Panel Monitoring System
K180504 · ACON Laboratories, Inc. · Mar 2018