# K981806: ALKP

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 22, 1998 after 32 days
- Product code: CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K823213 (1982). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K823213: Diagnostics Alkaline Phosphatase Optimi, Boehringer Mannheim Corp. (1982) Summary page 1.

## Most influential descendants
- K023807: Modification to Alkp (2002), 2 descendants of its own
- K240468: Alkaline Phosphatase (2024), 0 descendants of its own
- K223317: Alkaline Phosphatase2 (2023), 0 descendants of its own

## Recalls of this device
- Aug 26, 2011 · Not classified · Z-3278-2011: The reagent has the potential to be contaminated with mold, the Cladosporium fungal species.

## Indications for use
The Alkaline Phosphatase assay is intended to measure alkaline phosphatase in serum or plasma. Measurement of alkaline phosphatase is used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Source page: https://510kreport.com/device/K981806
Methodology: https://510kreport.com/methodology