Cleared Traditional

TOTAL CHOLESTEROL REAGENT SET (K840189) - FDA 510(k) Clearance

Class I Chemistry device.

K840189 · Preventive Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
65d
Days
Class 1
Risk

K840189 is an FDA 510(k) clearance for the TOTAL CHOLESTEROL REAGENT SET. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Preventive Diagnostics Corp. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 65 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 Preventive Diagnostics Corp. devices

Submission Details

510(k) Number K840189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1984
Decision Date March 23, 1984
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 88d · This submission: 65d
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 K840189.
SYSTEMATE CHOLESTEROL 67222
K843327 · Em Diagnostic Systems, Inc. · Sep 1984
TDX REA CHOLESTEROL
K842320 · Abbott Laboratories · Aug 1984
MULTIPLE CHEM. MODULE FOR ANALYSIS
K841182 · Beckman Instruments, Inc. · May 1984
CHOLESTEROL HIGH PERFORMANCE-K
K832158 · Boehringer Mannheim Corp. · Aug 1983
CHOLESTEROL CHOD-PAP TEST
K823302 · Boehringer Mannheim Corp. · Dec 1982
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K820263 · Eastman Kodak Company · Feb 1982