510(k) · Cleared
ClearedUbi Magiwel Pap (Prostatic Acid Phosphatase) Eia Quantitatve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Biotech, Inc. · JFH Acid Phosphatase (Prostatic), Tartrate Inhibited
Cleared on Sep 15, 1998 after a 134-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 15, 1998
- Review
- 134 days
- Class
- Class II
- Product code
- JFH
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JFH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JFH devicesJFH Acid Phosphatase (Prostatic), Tartrate Inhibited: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFH
FDA has decided no JFH device since 2007.
Median 510(k) review, days · JFH
Too few JFH 510(k)s in any year since 2007 to give a median.
Recalls per year · JFH
No recall names JFH since 2007.
Adverse event reports per year · JFH
No MAUDE report names JFH since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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)
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981573: Ubi Magiwel Pap (Prostatic Acid Phosphatase) Eia Quantitatve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981573
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026