Cleared Traditional

K864302 - WAKO(TM) GOT II - HA

K864302 is the FDA 510(k) clearance for WAKO(TM) GOT II - HA by Wako Chemicals USA, Inc.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K864302 · Wako Chemicals USA, Inc. · Chemistry device
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Dec 1986
Decision
46d
Days
Class 2
Risk

K864302 is an FDA 510(k) clearance for the WAKO(TM) GOT II - HA. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on December 16, 1986 after a review of 46 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 Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K864302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1986
Decision Date December 16, 1986
Days to Decision 46 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
42d faster than avg
Panel avg: 88d · This submission: 46d
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 104
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K864302.
REFLOTRON(R) AST (GOT)
K870246 · Boehringer Mannheim Corp. · Feb 1987
WAKO (TM) AUTOKIT GOT TEST
K864813 · Wako Chemicals USA, Inc. · Feb 1987
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT
K864357 · Trace Scientific , Ltd. · Feb 1987
EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95
K863963 · Em Diagnostic Systems, Inc. · Nov 1986
AST/GOT PROCEDURE
K863257 · Data Medical Associates, Inc. · Sep 1986
SYSTEMATE (TM) ALANINE TRANSFERASE (ALT)
K863094 · Em Diagnostic Systems, Inc. · Aug 1986