Cleared Traditional

K864335 - WAKO GPT II - HA

K864335 is an FDA 510(k) clearance for WAKO GPT II - HA, manufactured by Wako Chemicals USA, Inc.. The device is a Class 1 Chemistry device with product code CKA cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K864335 · Wako Chemicals USA, Inc. · Chemistry device
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Dec 1986
Decision
42d
Days
Class 1
Risk

K864335 is an FDA 510(k) clearance for the WAKO GPT II - HA. 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 December 16, 1986 after a review of 42 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

FDA 510(k) Submission Details - K864335

510(k) Number K864335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1986
Decision Date December 16, 1986
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

CKA Device Classification - Class 1, General Controls

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 117
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K864335.
ALANINE AMINOTRANSFERASE (ALT)/(GPT)
K870086 · Catachem, Inc. · Mar 1987
WAKO(TM) AUTOKIT GPT
K864850 · Wako Chemicals USA, Inc. · Jan 1987
ALANINE AMINO TRANSFERASE ALT/SGPT
K864906 · Tech-Co, Inc. · Dec 1986
ALT S.C.E. (GPT)
K863053 · J. D. Assoc. · Dec 1986
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95
K863962 · Em Diagnostic Systems, Inc. · Nov 1986
ALT/GPT PROCEDURE
K863253 · Data Medical Associates, Inc. · Sep 1986