Cleared Traditional

ENZYMATIC CHOLESTROL REAGENT SET (K855187) - FDA 510(k) Clearance

Class I Chemistry device.

K855187 · Technostics Intl. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1986
Decision
19d
Days
Class 1
Risk

K855187 is an FDA 510(k) clearance for the ENZYMATIC CHOLESTROL REAGENT SET. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Technostics Intl. (Washington, US). The FDA issued a Cleared decision on January 14, 1986 after a review of 19 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 Technostics Intl. devices

Submission Details

510(k) Number K855187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date January 14, 1986
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 88d · This submission: 19d
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 58
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K855187.
EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95
K862707 · Em Diagnostic Systems, Inc. · Aug 1986
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
K861700 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1986
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