Cleared Traditional

K822493 - OPTIMIZED UV-GOT REAGENT SET

K822493 is an FDA 510(k) clearance for OPTIMIZED UV-GOT REAGENT SET, manufactured by Biorent Diagnostic, Inc.. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K822493 · Biorent Diagnostic, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1982
Decision
34d
Days
Class 2
Risk

K822493 is an FDA 510(k) clearance for the OPTIMIZED UV-GOT REAGENT SET. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Biorent Diagnostic, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1982 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1100 - 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 - K822493

510(k) Number K822493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1982
Decision Date September 21, 1982
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIT Device Classification - Class 2, Special Controls

Product Code CIT Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1100
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 - CIT Nadh Oxidation/nad Reduction, Ast/sgot

All 134
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K822493.
SGOT-UV REAGENT SET
K841066 · Medical Specialties, Inc. · May 1984
ASPARTATE AMINOTRANSFERASE REAGENT
K840706 · American Dade · Apr 1984
FLOW-PAC SGOT REAGENT
K830958 · Amresco, Inc. · May 1983
SGOT-UV REAGENT SET
K821208 · Omega Medical Electronics · Jul 1982
ULTRAZYME PLUS GOT
K821876 · Harleco Diagnostics · Jul 1982
BECKMAN LIQUID-STAT AST-UV LIQUID
K821433 · Beckman Instruments, Inc. · Jun 1982