Cleared Traditional

K771152 - DYNAZYME II GPT 340

K771152 is the FDA 510(k) clearance for DYNAZYME II GPT 340 by J.T. Baker Chemical Co.. It is a Class 1 Chemistry device (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

Submission Details

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.

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 99
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
ALANINE TRANSAMINASE
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
ULTRAZYME PLUS GPT
K770882 · Harleco · Jul 1977
GEMENI GPT (ALT) ASSAY
K761269 · Electro-Nucleonics Laboratories, Inc. · Dec 1976