Cleared Traditional

T-CHO REAGENT (K852009) - FDA 510(k) Clearance

Class I Chemistry device.

K852009 · Alpkem Corp. · Chemistry device
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May 1985
Decision
23d
Days
Class 1
Risk

K852009 is an FDA 510(k) clearance for the T-CHO 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 30, 1985 after a review of 23 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 Alpkem Corp. devices

Submission Details

510(k) Number K852009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1985
Decision Date May 30, 1985
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
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 K852009.
KODAK EKTACHEM HDL CHOLESTEROL KIT
K854426 · Eastman Kodak Company · Jan 1986
ASTRA SYSTEMS CHOLESTEROL REAGENT
K853854 · Beckman Instruments, Inc. · Oct 1985
QCA ENZYMATIC CHOLESTEROL
K853871 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1985
PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE
K844655 · Boehringer Mannheim Corp. · Jan 1985
PDA CHOLESTEROL
K843510 · Abbott Laboratories · Sep 1984
SYSTEMATE CHOLESTEROL 67222
K843327 · Em Diagnostic Systems, Inc. · Sep 1984