Cleared Traditional

TOTAL CHOLESTEROL REAGENT SET (K820950) - FDA 510(k) Clearance

Class I Chemistry device.

K820950 · Sterling Biochemical, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1982
Decision
20d
Days
Class 1
Risk

K820950 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 Sterling Biochemical, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 26, 1982 after a review of 20 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 Sterling Biochemical, Inc. devices

Submission Details

510(k) Number K820950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1982
Decision Date April 26, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
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 K820950.
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
SERALYZER
K812100 · Miles Laboratories, Inc. · Aug 1981
LIQUID-STAT REAGENT FOR ASSAY OF CHOLES.
K803254 · Beckman Instruments, Inc. · Jan 1981