Cleared Traditional

K892238 - CLA 200 CHEMPRO LIPID ANALYZER

K892238 is the FDA 510(k) clearance for CLA 200 CHEMPRO LIPID ANALYZER by Johnson & Johnson Professionals, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K892238 · Johnson & Johnson Professionals, Inc. · Chemistry device
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Jun 1989
Decision
64d
Days
Class 1
Risk

K892238 is an FDA 510(k) clearance for the CLA 200 CHEMPRO(R) LIPID ANALYZER. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Roseville, US). The FDA issued a Cleared decision on June 7, 1989 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K892238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1989
Decision Date June 07, 1989
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
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 130
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K892238.
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410
K893916 · Em Diagnostic Systems, Inc. · Aug 1989
CHOLESTEROL REAGENT SET
K893479 · American Monitor Corp. · Jun 1989
AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325
K891922 · American Research Products Co. · Jun 1989
TOTAL CHOLESTEROL REAGENT
K890334 · Alpkem Corp. · May 1989
EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE
K890990 · Hichem Diagnostics · Apr 1989
CLINISTAT CHOLESTEROL REAGENT TEST
K884757 · Heraeus Kulzer, Inc. · Mar 1989