Cleared Traditional

K981650 - AST/SGOT LIQUID REAGENT - KINETIC METHOD

K981650 is an FDA 510(k) clearance for AST/SGOT LIQUID REAGENT - KINETIC METHOD, manufactured by Teco Diagnostics. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K981650 · Teco Diagnostics · Chemistry device
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Jun 1998
Decision
49d
Days
Class 2
Risk

K981650 is an FDA 510(k) clearance for the AST/SGOT LIQUID REAGENT - KINETIC METHOD. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on June 29, 1998 after a review of 49 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 Teco Diagnostics devices

FDA 510(k) Submission Details - K981650

510(k) Number K981650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1998
Decision Date June 29, 1998
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
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 128
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K981650.
SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5
K992801 · Sigma Diagnostics, Inc. · Sep 1999
CARESIDE AST
K990009 · Careside, Inc. · Mar 1999
AST
K983131 · Abbott Laboratories · Sep 1998
AST
K981843 · Abbott Laboratories · Jun 1998
ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)
K981221 · Abbott Laboratories · Apr 1998
ASPARTATE AMINOTRANSFERASE (AST)
K981225 · Abbott Laboratories · Apr 1998