Cleared Traditional

K853854 - ASTRA SYSTEMS CHOLESTEROL REAGENT

K853854 is an FDA 510(k) clearance for ASTRA SYSTEMS CHOLESTEROL REAGENT, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K853854 · Beckman Instruments, Inc. · Chemistry device
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Oct 1985
Decision
42d
Days
Class 1
Risk

K853854 is an FDA 510(k) clearance for the ASTRA SYSTEMS CHOLESTEROL REAGENT. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Fullerton, US). The FDA issued a Cleared decision on October 28, 1985 after a review of 42 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K853854

510(k) Number K853854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1985
Decision Date October 28, 1985
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
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 137
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K853854.
TOTAL CHOLESTEROL REAGENT SET
K855028 · Sterling Diagnostics, Inc. · Jan 1986
KODAK EKTACHEM HDL CHOLESTEROL KIT
K854426 · Eastman Kodak Company · Jan 1986
IN-VITRO TEST FOR THE DETERMINATION OF CHOLESTEROL
K854179 · Clinical Data, Inc. · Nov 1985
QCA ENZYMATIC CHOLESTEROL
K853871 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1985
CHOLESTEROL METHOD
K852863 · Catachem, Inc. · Jul 1985
T-CHO REAGENT
K852009 · Alpkem Corp. · May 1985