Cleared Traditional

K893692 - EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405

K893692 is an FDA 510(k) clearance for EMDS ASPARTATE AMINOTRANSFERASE ITEM NU..., manufactured by Diagnostic Systems. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K893692 · Diagnostic Systems · Chemistry device
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Aug 1989
Decision
97d
Days
Class 2
Risk

K893692 is an FDA 510(k) clearance for the EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Diagnostic Systems (Gibbstown, US). The FDA issued a Cleared decision on August 21, 1989 after a review of 97 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 Diagnostic Systems devices

FDA 510(k) Submission Details - K893692

510(k) Number K893692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1989
Decision Date August 21, 1989
Days to Decision 97 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 88d · This submission: 97d
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 133
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K893692.
COBAS READY LIVER PROFILE REAGENT STRIP
K896233 · Roche Diagnostic Systems, Inc. · Feb 1990
ASPARTATE AMINOTRANFERASE (AST)
K896000 · American Monitor Corp. · Jan 1990
ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54)
K894180 · Abbott Laboratories · Sep 1989
AST REAGENT (PROCEDURE NUMBER 158)
K892844 · Sigma Chemical Co. · Jun 1989
AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT
K891468 · Trace Scientific , Ltd. · May 1989
ASPARTATE AMINOTRANSFERASE (AST)
K884724 · Catachem, Inc. · Mar 1989