Cleared Traditional

K820768 - COLORIMETRIC LDH REAGENT SET

K820768 is an FDA 510(k) clearance for COLORIMETRIC LDH REAGENT SET, manufactured by Biorent Diagnostic, Inc.. The device is a Class 2 Chemistry device with product code CFH cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K820768 · Biorent Diagnostic, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1982
Decision
23d
Days
Class 2
Risk

K820768 is an FDA 510(k) clearance for the COLORIMETRIC LDH REAGENT SET. Classified as Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase (product code CFH), Class II - Special Controls.

Submitted by Biorent Diagnostic, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1982 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1440 - 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

FDA 510(k) Submission Details - K820768

510(k) Number K820768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1982
Decision Date April 14, 1982
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFH Device Classification - Class 2, Special Controls

Product Code CFH Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CFH Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase

All 12
Devices cleared under the same product code (CFH) and FDA review panel - the closest regulatory comparables to K820768.
LACTATE DEHYDROGENASE (LDH) REAGENT SET
K860349 · Sterling Diagnostics, Inc. · Feb 1986
EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE
K852391 · Helena Laboratories · Oct 1985
WAKO LDH CII TEST
K842452 · Wako Chemicals USA, Inc. · Aug 1984
LDH REAGENT SET
K812836 · Anco Medical Reagents & Assoc. · Oct 1981
HYCEL LDH-INT TEST
K782176 · Hycel, Inc. · Jan 1979
LDH-INT TEST
K771343 · Hycel, Inc. · Aug 1977