Cleared Traditional

ALKP (K981806) - FDA 510(k) Clearance

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

K981806 · Abbott Laboratories · Chemistry device
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Optimized for regulatory review, auditing and printing
Jun 1998
Decision
32d
Days
Class 2
Risk

K981806 is an FDA 510(k) clearance for the ALKP. 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 June 22, 1998 after a review of 32 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 K981806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1998
Decision Date June 22, 1998
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
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 K981806.
COBAS INTEGRA ALP IFCC GEN.2
K033185 · Roche Diagnostics Corp. · Oct 2003
MODIFICATION TO ALKP
K023807 · Abbott Laboratories · Dec 2002
ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE
K981897 · Roche Diagnostic Systems, Inc. · Aug 1998
ALKALINE PHOSPHATASE (ALKP)
K981245 · Abbott Laboratories · May 1998
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245
K954840 · Sigma Diagnostics, Inc. · Feb 1996
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
K951584 · Sigma Diagnostics, Inc. · Aug 1995