Cleared Traditional

CHOLESTEROL TEST SYSTEM (K850390) - FDA 510(k) Clearance

Class I Hematology device.

K850390 · Hans J. Brouwers & Assoc. · Hematology device
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Jul 1985
Decision
158d
Days
Class 1
Risk

K850390 is an FDA 510(k) clearance for the CHOLESTEROL TEST SYSTEM. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Hans J. Brouwers & Assoc. (Mount Prospect, US). The FDA issued a Cleared decision on July 9, 1985 after a review of 158 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1175 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hans J. Brouwers & Assoc. devices

Submission Details

510(k) Number K850390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1985
Decision Date July 09, 1985
Days to Decision 158 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 113d · This submission: 158d
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 K850390.
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