Cleared Traditional

K890334 - TOTAL CHOLESTEROL REAGENT

K890334 is an FDA 510(k) clearance for TOTAL CHOLESTEROL REAGENT, manufactured by Alpkem Corp.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K890334 · Alpkem Corp. · Chemistry device
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May 1989
Decision
100d
Days
Class 1
Risk

K890334 is an FDA 510(k) clearance for the TOTAL CHOLESTEROL REAGENT. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on May 3, 1989 after a review of 100 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 Alpkem Corp. devices

FDA 510(k) Submission Details - K890334

510(k) Number K890334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date May 03, 1989
Days to Decision 100 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
12d slower than avg
Panel avg: 88d · This submission: 100d
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 187
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K890334.
CHOLESTEROL REAGENT SET
K893479 · American Monitor Corp. · Jun 1989
AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325
K891922 · American Research Products Co. · Jun 1989
CLA 200 CHEMPRO(R) LIPID ANALYZER
K892238 · Johnson & Johnson Professionals, Inc. · Jun 1989
EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE
K890990 · Hichem Diagnostics · Apr 1989
CLINISTAT CHOLESTEROL REAGENT TEST
K884757 · Heraeus Kulzer, Inc. · Mar 1989
CHOLESTEROL TEST ITEM NUMBER: SR1011
K885023 · Em Diagnostic Systems, Inc. · Feb 1989