Cleared Traditional

K780040 - ALANINE TRANSAMINASE

K780040 is an FDA 510(k) clearance for ALANINE TRANSAMINASE, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code CKA cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K780040 · Beckman Instruments, Inc. · Chemistry device
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Jan 1978
Decision
22d
Days
Class 1
Risk

K780040 is an FDA 510(k) clearance for the ALANINE TRANSAMINASE. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 31, 1978 after a review of 22 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K780040

510(k) Number K780040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1978
Decision Date January 31, 1978
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
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 102
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K780040.
ALT(GPT) UNI-UV, SGPT
K780462 · Sclavo, Inc. · May 1978
STAC SYSTEM
K780373 · Technicon Instruments Corp. · Apr 1978
ULTRAZYME PLUS GPT
K780102 · Harleco · Feb 1978
GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT
K772030 · Harleco · Nov 1977
DYNAZYME II GPT 340
K771152 · J.T. Baker Chemical Co. · Nov 1977
MULTISTAT III ALANINE AMINOTRANSFERASE
K771466 · Instrumentation Laboratory CO · Sep 1977