Cleared Traditional

K831863 - CHOLESTEROL-ENZYMATIC REAGENT SET

K831863 is the FDA 510(k) clearance for CHOLESTEROL-ENZYMATIC REAGENT SET by Stanbio Laboratory. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K831863 · Stanbio Laboratory · Chemistry device
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Jul 1983
Decision
42d
Days
Class 1
Risk

K831863 is an FDA 510(k) clearance for the CHOLESTEROL-ENZYMATIC REAGENT SET. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Stanbio Laboratory (Mchenry, US). The FDA issued a Cleared decision on July 22, 1983 after a review of 42 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 Stanbio Laboratory devices

Submission Details

510(k) Number K831863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1983
Decision Date July 22, 1983
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
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 108
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K831863.
DURAZYME CHOLESTEROL
K840368 · American Monitor Corp. · Mar 1984
FLOW-PAC SHOLESTEROL REAGENT SET
K832780 · American Research Products Co. · Oct 1983
CHOLESTEROL HIGH PERFORMANCE-K
K832158 · Boehringer Mannheim Corp. · Aug 1983
WAKO CHOLESTEROL CII
K831687 · Wako Chemicals USA, Inc. · Jul 1983
WAKO FREE CHOLESTEROL C TEST
K830761 · Wako Chemicals USA, Inc. · Apr 1983
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA
K830239 · Emd Chemicals, Inc. · Apr 1983