Cleared Traditional

K872575 - HDL CHOLESTEROL REAGENT

K872575 is the FDA 510(k) clearance for HDL CHOLESTEROL REAGENT by Sigma Chemical Co.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K872575 · Sigma Chemical Co. · Chemistry device
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Jul 1987
Decision
16d
Days
Class 1
Risk

K872575 is an FDA 510(k) clearance for the HDL CHOLESTEROL REAGENT. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on July 16, 1987 after a review of 16 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 Sigma Chemical Co. devices

Submission Details

510(k) Number K872575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1987
Decision Date July 16, 1987
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 88d · This submission: 16d
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 121
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K872575.
WAKO(TM) AUTOKIT CHOLESTEROL
K880311 · Wako Chemicals USA, Inc. · Mar 1988
BIOTROL CHOLESTEROL ENZYMATIQUE COLOR
K872930 · Biotrol, USA, Inc. · Aug 1987
CHOLESTEROL REAGENT
K872295 · Sigma Diagnostics, Inc. · Jul 1987
CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS
K870928 · Electro-Nucleonics Laboratories, Inc. · Apr 1987
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607
K870407 · Em Diagnostic Systems, Inc. · Mar 1987
CHOLESTEROL
K863927 · Tech-Co, Inc. · Nov 1986