# K981573: Ubi Magiwel Pap (Prostatic Acid Phosphatase) Eia Quantitatve

- Pathway: 510(k) (Traditional)
- Applicant: United Biotech, Inc.
- Decided: Sep 15, 1998 after 134 days
- Product code: JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited)
- Device class: 2
- Regulation: 21 CFR 862.1020
- Recalls of this device: none
- 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.

## Indications for use
The UBI MAGIWELT™ prostatic acid Phosphatase(PAP) CM-301 is a solid phase enzyme-linked immunosorbent assay(ELISA). This test kit provides quantitative measurement of PAP level in human serum to aid in the management and monitoring the effectiveness of “various therapeutic treatments of prostate cancer patients. (for Professional use only)

Source page: https://510kreport.com/device/K981573
Methodology: https://510kreport.com/methodology