Cleared Special

K240468 - Alkaline Phosphatase

K240468 is an FDA 510(k) clearance for Alkaline Phosphatase, manufactured by Abbott Laboratories Diagnostics Division. The device is a Class 2 Chemistry device with product code CJE cleared through the Special 510(k) pathway after a 239-day FDA review.

K240468 · Abbott Laboratories Diagnostics Division · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
239d
Days
Class 2
Risk

K240468 is an FDA 510(k) clearance for the Alkaline Phosphatase. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Abbott Laboratories Diagnostics Division (Irving, US). The FDA issued a Cleared decision on October 16, 2024 after a review of 239 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K240468

510(k) Number K240468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2024
Decision Date October 16, 2024
Days to Decision 239 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
150d slower than avg
Panel avg: 89d · This submission: 239d
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

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K240468 · Alkaline Phosphatase
Download PDF FDA Summary Abbott Laboratories D…