Cleared Traditional

K904031 - CHEMA CHOL CHOLESTEROL SYSTEM

K904031 is an FDA 510(k) clearance for CHEMA CHOL CHOLESTEROL SYSTEM, manufactured by Texas Intl. Laboratories, Inc.. The device is a Class 1 Chemistry device with 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.

FDA 510(k) Submission Details - K904031

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 89d · This submission: 192d
Pathway characteristics
Predicate-based equivalence.

CHH Device Classification - Class 1, General Controls

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 229
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K904031.
CHOLESTECH LIPID MONITORING SYS.
K912136 · Cholestech Corp. · Jul 1991
CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION
K911578 · Cholestech Corp. · May 1991
CHEMTRAK ACCUMETER CHOLESTEROL TEST
K905405 · Chemtrak, Inc. · Mar 1991
CRP LIPID REAGENT TEST PACK
K905648 · Cirrus Diagnostics, Inc. · Mar 1991
ECLIPSE ICA CHOLESTEROL
K905145 · Biotope, Inc. · Feb 1991
CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST
K910240 · Crystal Diagnostics, Inc. · Feb 1991
K904031 · CHEMA CHOL CHOLESTEROL SYSTEM
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