# K101185: Nucleic Acid Detection Immunoassay (Nadia) Psa Assay

- Pathway: 510(k) (Traditional)
- Applicant: Iris Molecular Diagnostics
- Decided: Sep 20, 2011 after 510 days
- Product code: OWM (Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers)
- Device class: 2
- Regulation: 21 CFR 866.6040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN070009 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN070009: Mammaprint, Agendia BV (2007). Our reading of the summary gave K062694, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN070009, Mammaprint (Agendia BV), granted Feb 6, 2007; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Indications for use
NADiA® ProsVue™ is an in-vitro diagnostic assay for determining rate of change of serum total prostate specific antigen over a period of time (slope, pg/mL per month). The NADiA® ProsVue™ assay is performed for patients having less than 0.1 ng/mL serum total PSA values (determined by standard-of-care assays that are FDA approved/cleared) in the first sample collected more than 6 weeks after radical prostatectomy. ProsVue™ slope is indicated for use as a prognostic marker in conjunction with clinical evaluation as an aid in identifying those patients at reduced risk for recurrence of prostate cancer for the eight year period following prostatectomy. The NADiA® ProsVue™ assay is not intended for the diagnosis or for the monitoring of prostate cancer.

Source page: https://510kreport.com/device/K101185
Methodology: https://510kreport.com/methodology