Cleared Traditional

ALT (SGPT) REAGENT SET (K880275) - FDA 510(k) Clearance

Class I Chemistry device.

K880275 · Tech-Neal Scientific, Inc. · Chemistry device
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Mar 1988
Decision
40d
Days
Class 1
Risk

K880275 is an FDA 510(k) clearance for the ALT (SGPT) REAGENT SET. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Tech-Neal Scientific, Inc. (Westmont, US). The FDA issued a Cleared decision on March 1, 1988 after a review of 40 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 Tech-Neal Scientific, Inc. devices

Submission Details

510(k) Number K880275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1988
Decision Date March 01, 1988
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
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 33
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K880275.
ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)
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ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652
K884376 · Em Diagnostic Systems, Inc. · Jan 1989
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
K883181 · Beckman Instruments, Inc. · Sep 1988
EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017
K874586 · Em Diagnostic Systems, Inc. · Jan 1988
PYRIDOXAL-5-PHOSPHATE TABLETS
K874835 · Boehringer Mannheim Corp. · Jan 1988
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95
K863962 · Em Diagnostic Systems, Inc. · Nov 1986