Cleared Traditional

K870246 - REFLOTRON AST (GOT)

K870246 is an FDA 510(k) clearance for REFLOTRON AST (GOT), manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K870246 · Boehringer Mannheim Corp. · Chemistry device
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Feb 1987
Decision
28d
Days
Class 2
Risk

K870246 is an FDA 510(k) clearance for the REFLOTRON(R) AST (GOT). Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 18, 1987 after a review of 28 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K870246

510(k) Number K870246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1987
Decision Date February 18, 1987
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 110
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K870246.
EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010
K874600 · Em Diagnostic Systems, Inc. · Jan 1988
BIOTROL AST/TGO MONOREACTIF
K872829 · Biotrol, USA, Inc. · Aug 1987
ASPARTATE AMINOTRANSFERASE (AST)/(GOT)
K870077 · Catachem, Inc. · Mar 1987
WAKO (TM) AUTOKIT GOT TEST
K864813 · Wako Chemicals USA, Inc. · Feb 1987
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
K864357 · Trace Scientific , Ltd. · Feb 1987
AST S.C.E. (GOT)
K863054 · J. D. Assoc. · Jan 1987