Cleared Traditional

K981245 - ALKALINE PHOSPHATASE (ALKP)

K981245 is an FDA 510(k) clearance for ALKALINE PHOSPHATASE (ALKP), manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K981245 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
44d
Days
Class 2
Risk

K981245 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE (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 May 20, 1998 after a review of 44 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

FDA 510(k) Submission Details - K981245

510(k) Number K981245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1998
Decision Date May 20, 1998
Days to Decision 44 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
44d faster than avg
Panel avg: 88d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJE Device Classification - Class 2, Special Controls

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 89
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K981245.
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
K000067 · Teco Diagnostics · Jan 2000
ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE
K981897 · Roche Diagnostic Systems, Inc. · Aug 1998
ALKP
K981806 · Abbott Laboratories · Jun 1998
ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30
K980316 · Diagnostic Chemicals , Ltd. · Feb 1998
LIQUID ALKALINE PHOSHATASE REAGENT SET
K973588 · Pointe Scientific, Inc., · Oct 1997
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245
K954840 · Sigma Diagnostics, Inc. · Feb 1996