Cleared Traditional

K952743 - ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM

K952743 is an FDA 510(k) clearance for ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM, manufactured by Medical Diagnostic Technologies, Inc.. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K952743 · Medical Diagnostic Technologies, Inc. · Chemistry device
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Sep 1995
Decision
105d
Days
Class 2
Risk

K952743 is an FDA 510(k) clearance for the ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on September 29, 1995 after a review of 105 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Diagnostic Technologies, Inc. devices

FDA 510(k) Submission Details - K952743

510(k) Number K952743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1995
Decision Date September 29, 1995
Days to Decision 105 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
17d slower than avg
Panel avg: 88d · This submission: 105d
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 132
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K952743.
AST INCORPORATING DST
K961114 · Trace Scientific , Ltd. · May 1996
ROCHE COBAS INTEGRA REAGENT CASSETTES
K954992 · Roche Diagnostic Systems, Inc. · Jan 1996
ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV
K954839 · Sigma Diagnostics, Inc. · Jan 1996
HICHEM AST REAGENT KIT
K951751 · Hichem Diagnostics · Aug 1995
AST QVET
K944102 · Prisma Systems · Dec 1994
LIQUID AST (SGOT)REAGENT SET
K941132 · Pointe Scientific, Inc., · May 1994