Cleared Traditional

K871676 - ENZYMATIC CHOLESTEROL REAGENT SET

K871676 is an FDA 510(k) clearance for ENZYMATIC CHOLESTEROL REAGENT SET, manufactured by Michclone Associates, Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K871676 · Michclone Associates, Inc. · Chemistry device
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May 1987
Decision
20d
Days
Class 1
Risk

K871676 is an FDA 510(k) clearance for the ENZYMATIC CHOLESTEROL REAGENT SET. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Michclone Associates, Inc. (Detroit, US). The FDA issued a Cleared decision on May 18, 1987 after a review of 20 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Michclone Associates, Inc. devices

FDA 510(k) Submission Details - K871676

510(k) Number K871676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1987
Decision Date May 18, 1987
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
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 188
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K871676.
BIOTROL CHOLESTEROL ENZYMATIQUE COLOR
K872930 · Biotrol, USA, Inc. · Aug 1987
CHOLESTEROL REAGENT
K872295 · Sigma Diagnostics, Inc. · Jul 1987
HDL CHOLESTEROL REAGENT
K872575 · Sigma Chemical Co. · Jul 1987
CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS
K870928 · Electro-Nucleonics Laboratories, Inc. · Apr 1987
CHOLESTEROL DETERMINATION
K871260 · Biochemical Trade, Inc. · Apr 1987
INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT
K870828 · Intersect Systems, Inc. · Mar 1987