Cleared Traditional

ACCESSORY HDL CHOLESTEROL REAGENT SET (K780638) - FDA 510(k) Clearance

Class I Chemistry device.

K780638 · The Dow Chemical Co. · Chemistry device
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May 1978
Decision
38d
Days
Class 1
Risk

K780638 is an FDA 510(k) clearance for the ACCESSORY HDL CHOLESTEROL REAGENT SET. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by The Dow Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on May 26, 1978 after a review of 38 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 The Dow Chemical Co. devices

Submission Details

510(k) Number K780638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1978
Decision Date May 26, 1978
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
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 K780638.
ACA HIGH DENSITY LIPOPROTEIN CHOLES.
K792509 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1980
ENZYMATIC DETERMINATION
K790724 · Sigma Chemical Co. · May 1979
REAGENT SYSTEM #350HDL, SIGMA PROCEDURE
K790760 · Sigma Chemical Co. · May 1979
REAGENT SET HDL CHOLESTEROL
K780635 · Boehringer Mannheim Corp. · May 1978
MULTISTAT III CHOLESTEROL TEST
K771508 · Instrumentation Laboratory CO · Sep 1977
HOLESTEROL DELTA TEST ASSAY
K771582 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1977