Cleared Traditional

K811760 - CHOLESTEROL DETERMINATION

K811760 is the FDA 510(k) clearance for CHOLESTEROL DETERMINATION by Biorent Diagnostic, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K811760 · Biorent Diagnostic, Inc. · Chemistry device
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Jul 1981
Decision
18d
Days
Class 1
Risk

K811760 is an FDA 510(k) clearance for the CHOLESTEROL DETERMINATION. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Biorent Diagnostic, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981 after a review of 18 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 Biorent Diagnostic, Inc. devices

Submission Details

510(k) Number K811760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1981
Decision Date July 10, 1981
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 88d · This submission: 18d
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 130
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K811760.
ULTRACHEM E-CHOL, ITEM #65025
K813039 · Harleco · Nov 1981
FAST CHOLES-CINET
K812091 · Sclavo, Inc. · Aug 1981
SERALYZER
K812100 · Miles Laboratories, Inc. · Aug 1981
ENZYMATIC CHOLESTEROL
K810673 · Pointe Scientific, Inc., · Mar 1981
CHOLESTEROL REAGENT
K810405 · Gilford Diagnostics · Feb 1981
LIQUID-STAT REAGENT FOR ASSAY OF CHOLES.
K803254 · Beckman Instruments, Inc. · Jan 1981