Cleared Traditional

K935181 - ASPARTATE AMINOTRANSFERASE (AST) TEST (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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.