Cleared Traditional

K904031 - CHEMA CHOL CHOLESTEROL SYSTEM

K904031 is the FDA 510(k) clearance for CHEMA CHOL CHOLESTEROL SYSTEM by Texas Intl. Laboratories, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K904031 · Texas Intl. Laboratories, Inc. · Chemistry device
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Mar 1991
Decision
192d
Days
Class 1
Risk

K904031 is an FDA 510(k) clearance for the CHEMA CHOL CHOLESTEROL SYSTEM. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Texas Intl. Laboratories, Inc. (Houston, US). The FDA issued a Cleared decision on March 11, 1991 after a review of 192 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 Texas Intl. Laboratories, Inc. devices

Submission Details

510(k) Number K904031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1990
Decision Date March 11, 1991
Days to Decision 192 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 88d · This submission: 192d
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 127
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K904031.
ABBOTT QUICKSTART CHOLESTEROL TEST
K913565 · Em Diagnostic Systems, Inc. · Dec 1991
KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST
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PROACT CHOLESTEROL SYSTEMS
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SYNERMED CHOLESTEROL REAGENT KIT
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LIQUID STABLE CHOLESTEROL REAGENT KIT
K902678 · Trace Scientific , Ltd. · Sep 1990
CHOLESTEROL (RATE) REAGENT
K902098 · Sigma Chemical Co. · Aug 1990