Cleared Traditional

ABBOTT CLINICAL CHEMISTRY REAGENT ALP (K890521) - FDA 510(k) Clearance

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

K890521 · Abbott Laboratories · Chemistry device
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Mar 1989
Decision
50d
Days
Class 2
Risk

K890521 is an FDA 510(k) clearance for the ABBOTT CLINICAL CHEMISTRY REAGENT ALP. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on March 24, 1989 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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 K890521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1989
Decision Date March 24, 1989
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 - CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 41
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K890521.
SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483
K910639 · Em Diagnostic Systems, Inc. · Apr 1991
ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT
K902560 · Roche Diagnostic Systems, Inc. · Jul 1990
SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402
K895250 · Em Diagnostic Systems, Inc. · Oct 1989
ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651
K884549 · Em Diagnostic Systems, Inc. · Nov 1988
EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021
K873635 · Em Diagnostic Systems, Inc. · Oct 1987
WAKO(TM) AUTOKIT ALP
K873333 · Wako Chemicals USA, Inc. · Oct 1987