Cleared Special

K023807 - MODIFICATION TO ALKP

K023807 is an FDA 510(k) clearance for MODIFICATION TO ALKP, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CJE cleared through the Special 510(k) pathway after a 42-day FDA review.

K023807 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
42d
Days
Class 2
Risk

K023807 is an FDA 510(k) clearance for the MODIFICATION TO 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 December 26, 2002 after a review of 42 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K023807

510(k) Number K023807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2002
Decision Date December 26, 2002
Days to Decision 42 days
Submission Type Special
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
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

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 118
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K023807.
ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL
K073191 · Thermofisher Scientific OY · Feb 2008
GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K060205 · Horiba Abx · Jul 2006
COBAS INTEGRA ALP IFCC GEN.2
K033185 · Roche Diagnostics Corp. · Oct 2003
WIENER LAB. ALP 405
K013983 · Wiener Laboratories Saic · Jan 2002
TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113
K012518 · Thermo Dma, Inc. · Oct 2001
ALKALINE PHOSPHATASE LIQUID REAGENT
K011599 · Jas Diagnostics, Inc. · Jul 2001