Cleared Traditional

TOTAL CHOLESTEROL REAGENT (K890334) - FDA 510(k) Clearance

Class I Chemistry device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 88d · This submission: 100d
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 53
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K890334.
VISION WHOLE BLOOD HDL CHOLESTEROL
K895158 · Abbott Laboratories · Oct 1989
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410
K893916 · Em Diagnostic Systems, Inc. · Aug 1989
CLA 200 CHEMPRO(R) LIPID ANALYZER
K892238 · Johnson & Johnson Professionals, Inc. · Jun 1989
CHOLESTEROL TEST ITEM NUMBER: SR1011
K885023 · Em Diagnostic Systems, Inc. · Feb 1989
HDL CHOLESTEROL REAGENT
K872575 · Sigma Chemical Co. · Jul 1987
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607
K870407 · Em Diagnostic Systems, Inc. · Mar 1987