Cleared Traditional

OLYMPUS CHOLESTEROL REAGENT (K922231) - FDA 510(k) Clearance

Class I Chemistry device.

K922231 · Olympus Corp. · Chemistry device
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Nov 1992
Decision
190d
Days
Class 1
Risk

K922231 is an FDA 510(k) clearance for the OLYMPUS CHOLESTEROL REAGENT. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on November 18, 1992 after a review of 190 days - an extended review 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: 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 Olympus Corp. devices

Submission Details

510(k) Number K922231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1992
Decision Date November 18, 1992
Days to Decision 190 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 88d · This submission: 190d
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 61
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K922231.
CHOLESTEROL (CHOL) TEST ITEM NO. 65410
K935136 · Em Diagnostic Systems, Inc. · Dec 1993
OLYMPUS CHOLESTEROL REAGENT
K925603 · Olympus Corp. · Feb 1993
CHOLESTEROL TEST ITEM# 42374/93, 42322/R1
K924508 · Em Diagnostic Systems, Inc. · Jan 1993
CHOLESTEROL TEST
K923733 · Em Diagnostic Systems, Inc. · Oct 1992
ABBOTT QUICKSTART CHOLESTEROL TEST
K913565 · Em Diagnostic Systems, Inc. · Dec 1991
PROACT CHOLESTEROL SYSTEMS
K912212 · Boehringer Mannheim Corp. · Aug 1991