# K895528: Gel Alkaline Phosphatase Isoenzyme Control NO.5104

- Pathway: 510(k) (Traditional)
- Applicant: Helena Laboratories
- Decided: Oct 25, 1989 after 49 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 1 (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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 7, 2016 · Class III · Z-0529-2019: Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.

Source page: https://510kreport.com/device/K895528
Methodology: https://510kreport.com/methodology