Cleared Traditional

K864850 - WAKO(TM) AUTOKIT GPT

K864850 is the FDA 510(k) clearance for WAKO(TM) AUTOKIT GPT by Wako Chemicals USA, Inc.. It is a Class 1 Chemistry device (product code CKA) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K864850 · Wako Chemicals USA, Inc. · Chemistry device
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Jan 1987
Decision
30d
Days
Class 1
Risk

K864850 is an FDA 510(k) clearance for the WAKO(TM) AUTOKIT GPT. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on January 9, 1987 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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 K864850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1986
Decision Date January 09, 1987
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CKA Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CKA Nadh Oxidation/nad Reduction, Alt/sgpt

All 97
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K864850.
MODIFIED ALT (GPT) REAGENT
K872483 · Trace Scientific , Ltd. · Aug 1987
BIOTROL ALT/TGP MONOREACTIF
K872830 · Biotrol, USA, Inc. · Aug 1987
ALANINE AMINOTRANSFERASE (ALT)/(GPT)
K870086 · Catachem, Inc. · Mar 1987
ALANINE AMINO TRANSFERASE ALT/SGPT
K864906 · Tech-Co, Inc. · Dec 1986
WAKO GPT II - HA
K864335 · Wako Chemicals USA, Inc. · Dec 1986
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95
K863962 · Em Diagnostic Systems, Inc. · Nov 1986