Cleared Traditional

K880276 - AST (SGOT) REAGENT SET

K880276 is an FDA 510(k) clearance for AST (SGOT) REAGENT SET, manufactured by Tech-Neal Scientific, Inc.. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K880276 · Tech-Neal Scientific, Inc. · Chemistry device
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Mar 1988
Decision
42d
Days
Class 2
Risk

K880276 is an FDA 510(k) clearance for the AST (SGOT) REAGENT SET. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Tech-Neal Scientific, Inc. (Westmont, US). The FDA issued a Cleared decision on March 3, 1988 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1100 - 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

FDA 510(k) Submission Details - K880276

510(k) Number K880276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1988
Decision Date March 03, 1988
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIT Device Classification - Class 2, Special Controls

Product Code CIT Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CIT Nadh Oxidation/nad Reduction, Ast/sgot

All 130
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K880276.
CLINISTAT SGOT (AST) REAGENT TEST
K885156 · Heraeus Kulzer, Inc. · Feb 1989
ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654
K884377 · Em Diagnostic Systems, Inc. · Dec 1988
ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC)
K880692 · Diagnostic Chemicals, Ltd. (Usa) · May 1988
ASPARTATE AMINOTRANSFERASE AST/SGOT
K875071 · Tech-Co, Inc. · Feb 1988
EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010
K874600 · Em Diagnostic Systems, Inc. · Jan 1988
BIOTROL AST/TGO MONOREACTIF
K872829 · Biotrol, USA, Inc. · Aug 1987