Cleared Traditional

ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54) (K894180) - FDA 510(k) Clearance

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

K894180 · Abbott Laboratories · Chemistry device
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Sep 1989
Decision
89d
Days
Class 2
Risk

K894180 is an FDA 510(k) clearance for the ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54). Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on September 13, 1989 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

Submission Details

510(k) Number K894180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1989
Decision Date September 13, 1989
Days to Decision 89 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
1d slower than avg
Panel avg: 88d · This submission: 89d
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.

Regulatory Peers - CIT Nadh Oxidation/nad Reduction, Ast/sgot

All 51
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K894180.
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K896233 · Roche Diagnostic Systems, Inc. · Feb 1990
AST REAGENT (PROCEDURE NUMBER 158)
K892844 · Sigma Chemical Co. · Jun 1989
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K885156 · Heraeus Kulzer, Inc. · Feb 1989
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K884377 · Em Diagnostic Systems, Inc. · Dec 1988