Cleared Traditional

K883844 - HI CHEM KINETIC CHOLESTEROL REAGENT #88218

K883844 is the FDA 510(k) clearance for HI CHEM KINETIC CHOLESTEROL REAGENT #88218 by Hichem Diagnostics. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K883844 · Hichem Diagnostics · Chemistry device
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Oct 1988
Decision
49d
Days
Class 1
Risk

K883844 is an FDA 510(k) clearance for the HI CHEM KINETIC CHOLESTEROL REAGENT #88218. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on October 31, 1988 after a review of 49 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 Hichem Diagnostics devices

Submission Details

510(k) Number K883844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1988
Decision Date October 31, 1988
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
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 128
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K883844.
CLINISTAT CHOLESTEROL REAGENT TEST
K884757 · Heraeus Kulzer, Inc. · Mar 1989
CHOLESTEROL TEST ITEM NUMBER: SR1011
K885023 · Em Diagnostic Systems, Inc. · Feb 1989
HDL-CHOLESTEROL PRECIPITATING REAGENT
K883543 · Medical Analysis Systems, Inc. · Dec 1988
(SKD) CHOLESTEROL TEST KIT
K875131 · Smithkline Diagnostics, Inc. · Mar 1988
WAKO(TM) AUTOKIT CHOLESTEROL
K880311 · Wako Chemicals USA, Inc. · Mar 1988
BIOTROL CHOLESTEROL ENZYMATIQUE COLOR
K872930 · Biotrol, USA, Inc. · Aug 1987