Cleared Traditional

CHOLESTEROL TEST KIT (K895951) - FDA 510(k) Clearance

Class I Chemistry device.

K895951 · Elite Technology, Inc. · Chemistry device
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Feb 1990
Decision
128d
Days
Class 1
Risk

K895951 is an FDA 510(k) clearance for the CHOLESTEROL TEST KIT. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Elite Technology, Inc. (Canada M9w 5p1, CA). The FDA issued a Cleared decision on February 16, 1990 after a review of 128 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 Elite Technology, Inc. devices

Submission Details

510(k) Number K895951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1989
Decision Date February 16, 1990
Days to Decision 128 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 88d · This submission: 128d
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 53
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K895951.
PROACT CHOLESTEROL SYSTEMS
K912212 · Boehringer Mannheim Corp. · Aug 1991
CHOLESTEROL (RATE) REAGENT
K902098 · Sigma Chemical Co. · Aug 1990
EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410
K900850 · Em Diagnostic Systems, Inc. · Mar 1990
COBAS READY CHOLESTEROL REAGENT
K896239 · Roche Diagnostic Systems, Inc. · Feb 1990
VISION WHOLE BLOOD HDL CHOLESTEROL
K895158 · Abbott Laboratories · Oct 1989
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410
K893916 · Em Diagnostic Systems, Inc. · Aug 1989