Cleared Traditional

K883205 - ALTLTS ALANINE AMINO TRANSFERASE ALT

K883205 is an FDA 510(k) clearance for ALTLTS ALANINE AMINO TRANSFERASE ALT, manufactured by Electro-Nucleonics, Inc.. The device is a Class 1 Chemistry device with product code CKA cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K883205 · Electro-Nucleonics, Inc. · Chemistry device
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Sep 1988
Decision
43d
Days
Class 1
Risk

K883205 is an FDA 510(k) clearance for the ALTLTS ALANINE AMINO TRANSFERASE ALT. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Electro-Nucleonics, Inc. (Columbia, US). The FDA issued a Cleared decision on September 9, 1988 after a review of 43 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 Electro-Nucleonics, Inc. devices

FDA 510(k) Submission Details - K883205

510(k) Number K883205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1988
Decision Date September 09, 1988
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
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 118
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K883205.
ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652
K884376 · Em Diagnostic Systems, Inc. · Jan 1989
ALANINE AMINOTRANSFERASE
K884936 · Catachem, Inc. · Jan 1989
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
K883181 · Beckman Instruments, Inc. · Sep 1988
MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE
K875079 · Miles Laboratories, Inc. · Apr 1988
ALT (SGPT) REAGENT SET
K880275 · Tech-Neal Scientific, Inc. · Mar 1988
EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017
K874586 · Em Diagnostic Systems, Inc. · Jan 1988