Cleared Traditional

K896000 - ASPARTATE AMINOTRANFERASE (AST)

K896000 is an FDA 510(k) clearance for ASPARTATE AMINOTRANFERASE (AST), manufactured by American Monitor Corp.. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K896000 · American Monitor Corp. · Chemistry device
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Jan 1990
Decision
90d
Days
Class 2
Risk

K896000 is an FDA 510(k) clearance for the ASPARTATE AMINOTRANFERASE (AST). Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by American Monitor Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 11, 1990 after a review of 90 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 American Monitor Corp. devices

FDA 510(k) Submission Details - K896000

510(k) Number K896000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1989
Decision Date January 11, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
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 K896000.
COBAS READY CARDIO PROFILE REAGENT STRIP
K896228 · Roche Diagnostic Systems, Inc. · Feb 1990
COBAS READY PROFILE 1 REAGENT STRIP
K896229 · Roche Diagnostic Systems, Inc. · Feb 1990
COBAS READY LIVER PROFILE REAGENT STRIP
K896233 · Roche Diagnostic Systems, Inc. · Feb 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