# K973588: Liquid Alkaline Phoshatase Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: Oct 22, 1997 after 30 days
- Product code: CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Feb 7, 2008 · Not classified · Z-1355-2008: May be contaminated with microorganisms.
- Feb 7, 2008 · Not classified · Z-1360-2008: May be contaminated with microorganisms.
- Feb 7, 2008 · Not classified · Z-1356-2008: May be contaminated with microorganisms.
- Feb 7, 2008 · Not classified · Z-1358-2008: May be contaminated with microorganisms.
- Feb 7, 2008 · Not classified · Z-1354-2008: May be contaminated with microorganisms.
- Feb 7, 2008 · Not classified · Z-1353-2008: May be contaminated with microorganisms.
- Feb 7, 2008 · Not classified · Z-1359-2008: May be contaminated with microorganisms.
- Feb 7, 2008 · Not classified · Z-1357-2008: May be contaminated with microorganisms.
- Jun 9, 2006 · Not classified · Z-1389-06: The reagent may be contaminated with microorganisms.
- Jun 9, 2006 · Not classified · Z-1392-06: The reagent may be contaminated with microorganisms.
- Jun 9, 2006 · Not classified · Z-1390-06: The reagent may be contaminated with microorganisms.
- Jun 9, 2006 · Not classified · Z-1393-06: The reagent may be contaminated with microorganisms.
- Jun 9, 2006 · Not classified · Z-1394-06: The reagent may be contaminated with microorganisms.
- Jun 9, 2006 · Not classified · Z-1397-06: The reagent may be contaminated with microorganisms.
- Jun 9, 2006 · Not classified · Z-1396-06: The reagent may be contaminated with microorganisms.
- Jun 9, 2006 · Not classified · Z-1388-06: The reagent may be contaminated with microorganisms.
- Jun 9, 2006 · Not classified · Z-1395-06: The reagent may be contaminated with microorganisms.
- Jun 9, 2006 · Not classified · Z-1391-06: The reagent may be contaminated with microorganisms.

## Indications for use
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of alkaline phosphatase in serum. It is intended for in vitro diagnostic use only. The determination of alkaline phosphatase in serum is most commonly performed for the diagnosis of two groups of conditions: hepatobiliary disease and bone disease associated with increased osteoblastic activity.

Source page: https://510kreport.com/device/K973588
Methodology: https://510kreport.com/methodology