Cleared Traditional

K872829 - BIOTROL AST/TGO MONOREACTIF

K872829 is the FDA 510(k) clearance for BIOTROL AST/TGO MONOREACTIF by Biotrol, USA, Inc.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K872829 · Biotrol, USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1987
Decision
27d
Days
Class 2
Risk

K872829 is an FDA 510(k) clearance for the BIOTROL AST/TGO MONOREACTIF. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Biotrol, USA, Inc. (Berwyn, US). The FDA issued a Cleared decision on August 13, 1987 after a review of 27 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 Biotrol, USA, Inc. devices

Submission Details

510(k) Number K872829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1987
Decision Date August 13, 1987
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 107
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K872829.
ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC)
K880692 · Diagnostic Chemicals, Ltd. (Usa) · May 1988
ASPARTATE AMINOTRANSFERASE AST/SGOT
K875071 · Tech-Co, Inc. · Feb 1988
EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010
K874600 · Em Diagnostic Systems, Inc. · Jan 1988
ASPARTATE AMINOTRANSFERASE (AST)/(GOT)
K870077 · Catachem, Inc. · Mar 1987
REFLOTRON(R) AST (GOT)
K870246 · Boehringer Mannheim Corp. · Feb 1987
WAKO (TM) AUTOKIT GOT TEST
K864813 · Wako Chemicals USA, Inc. · Feb 1987