Cleared Traditional

K991663 - AST/SGOT

K991663 is an FDA 510(k) clearance for AST/SGOT, manufactured by A.P. Total Care, Inc.. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K991663 · A.P. Total Care, Inc. · Chemistry device
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Jun 1999
Decision
47d
Days
Class 2
Risk

K991663 is an FDA 510(k) clearance for the AST/SGOT. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by A.P. Total Care, Inc. (Bridgeport, US). The FDA issued a Cleared decision on June 30, 1999 after a review of 47 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 A.P. Total Care, Inc. devices

FDA 510(k) Submission Details - K991663

510(k) Number K991663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1999
Decision Date June 30, 1999
Days to Decision 47 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
41d faster than avg
Panel avg: 88d · This submission: 47d
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 K991663.
WAKO L-TYPE GOT TEST
K993468 · Wako Chemicals USA, Inc. · Dec 1999
BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
K992136 · Bayer Corp. · Nov 1999
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/SGOT LIQUID REAGENT - KINETIC METHOD
K981650 · Teco Diagnostics · Jun 1998