Cleared Traditional

K935181 - ASPARTATE AMINOTRANSFERASE (AST) TEST

K935181 is an FDA 510(k) clearance for ASPARTATE AMINOTRANSFERASE (AST) TEST, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K935181 · Em Diagnostic Systems, Inc. · Chemistry device
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Jan 1994
Decision
93d
Days
Class 2
Risk

K935181 is an FDA 510(k) clearance for the ASPARTATE AMINOTRANSFERASE (AST) TEST. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 93 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 Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K935181

510(k) Number K935181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1993
Decision Date January 27, 1994
Days to Decision 93 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
5d slower than avg
Panel avg: 88d · This submission: 93d
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 K935181.
AST QVET
K944102 · Prisma Systems · Dec 1994
LIQUID AST (SGOT)REAGENT SET
K941132 · Pointe Scientific, Inc., · May 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE
K934413 · Eastman Kodak Company · Apr 1994
STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020
K932049 · Stanbio Laboratory · Nov 1993
OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT
K925155 · Olympus Corp. · Jan 1993
ROCHE REAGENT FOR AST
K924244 · Roche Diagnostic Systems, Inc. · Jan 1993