Cleared Traditional

K902678 - LIQUID STABLE CHOLESTEROL REAGENT KIT

K902678 is the FDA 510(k) clearance for LIQUID STABLE CHOLESTEROL REAGENT KIT by Trace Scientific , Ltd.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K902678 · Trace Scientific , Ltd. · Chemistry device
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Sep 1990
Decision
98d
Days
Class 1
Risk

K902678 is an FDA 510(k) clearance for the LIQUID STABLE CHOLESTEROL REAGENT KIT. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Trace Scientific , Ltd. (Clayton, Vic 3168, AU). The FDA issued a Cleared decision on September 25, 1990 after a review of 98 days - within the typical 510(k) review window.

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 Trace Scientific , Ltd. devices

Submission Details

510(k) Number K902678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1990
Decision Date September 25, 1990
Days to Decision 98 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
10d slower than avg
Panel avg: 88d · This submission: 98d
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 126
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K902678.
KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST
K912499 · King Diagnostics, Inc. · Sep 1991
PROACT CHOLESTEROL SYSTEMS
K912212 · Boehringer Mannheim Corp. · Aug 1991
SYNERMED CHOLESTEROL REAGENT KIT
K903015 · Synermed, Inc. · Oct 1990
CHOLESTEROL (RATE) REAGENT
K902098 · Sigma Chemical Co. · Aug 1990
COULTER CHOLESTEROL REAGENT
K897162 · Coulter Electronics, Inc. · Mar 1990
EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410
K900850 · Em Diagnostic Systems, Inc. · Mar 1990