Cleared Traditional

ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55) (K890698) - FDA 510(k) Clearance

Class I Chemistry device.

K890698 · Abbott Laboratories · Chemistry device
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Apr 1989
Decision
59d
Days
Class 1
Risk

K890698 is an FDA 510(k) clearance for the ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55). Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on April 10, 1989 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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 K890698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1989
Decision Date April 10, 1989
Days to Decision 59 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
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CKA Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CKA Nadh Oxidation/nad Reduction, Alt/sgpt

All 49
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K890698.
TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES
K892930 · Technicon Instruments Corp. · Jul 1989
ALT REAGENT (PROCEDURE NUMBER 159)
K893560 · Sigma Chemical Co. · Jul 1989
ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403
K893752 · Em Diagnostic Systems, Inc. · Jul 1989
CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN
K885144 · Heraeus Kulzer, Inc. · Feb 1989
ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652
K884376 · Em Diagnostic Systems, Inc. · Jan 1989
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
K883181 · Beckman Instruments, Inc. · Sep 1988