Cleared Traditional

K923504 - CHOLESTEROL ENZYMATIC ENDPOINT

K923504 is the FDA 510(k) clearance for CHOLESTEROL ENZYMATIC ENDPOINT by Randox Laboratories, Ltd.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 544-day FDA review.

K923504 · Randox Laboratories, Ltd. · Chemistry device
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Jan 1994
Decision
544d
Days
Class 1
Risk

K923504 is an FDA 510(k) clearance for the CHOLESTEROL ENZYMATIC ENDPOINT. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Randox Laboratories, Ltd. (Antrim, N. Ireland, IR). The FDA issued a Cleared decision on January 10, 1994 after a review of 544 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K923504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1992
Decision Date January 10, 1994
Days to Decision 544 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
456d slower than avg
Panel avg: 88d · This submission: 544d
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 K923504.
DMA TOTAL CHOLESTEROL PROCEDURE
K946161 · Data Medical Associates, Inc. · Aug 1995
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY
K952127 · Boehringer Mannheim Corp. · Jul 1995
ROCHE REAGENT
K941573 · Roche Diagnostic Systems, Inc. · Oct 1994
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