Cleared Traditional

K771152 - DYNAZYME II GPT 340

K771152 is an FDA 510(k) clearance for DYNAZYME II GPT 340, manufactured by J.T. Baker Chemical Co.. The device is a Class 1 Chemistry device with product code CKA cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K771152 · J.T. Baker Chemical Co. · Chemistry device
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Nov 1977
Decision
129d
Days
Class 1
Risk

K771152 is an FDA 510(k) clearance for the DYNAZYME II GPT 340. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1977 after a review of 129 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all J.T. Baker Chemical Co. devices

FDA 510(k) Submission Details - K771152

510(k) Number K771152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1977
Decision Date November 03, 1977
Days to Decision 129 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
41d slower than avg
Panel avg: 88d · This submission: 129d
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 K771152.
ULTRAZYME PLUS GPT
K780102 · Harleco · Feb 1978
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K780040 · Beckman Instruments, Inc. · Jan 1978
GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT
K772030 · Harleco · Nov 1977
MULTISTAT III ALANINE AMINOTRANSFERASE
K771466 · Instrumentation Laboratory CO · Sep 1977
SERUM GLUTAMIC PYRUVIC TRANSAMINASE
K770991 · Macomb Chemical Co. · Aug 1977
ULTRAZYME PLUS GPT
K770882 · Harleco · Jul 1977