OYAClass III

P2psa

Unknown

OYA is the FDA product code for P2psa, a class III device type. FDA's definition for this code reads: "Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi)". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: OYA
Device name: P2psa
FDA definition: Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi)
Device class: Class III
Review panel: Unknown
Submission type: PMA
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

Siemens Healthcare Diagnostics Inc.

Recent clearances

Product code OYA

FDA records hold no clearances under product code OYA.

Recent recalls

Product code OYA

Z-2043-2023Class IIReagent lot numbers include an insufficient concentration of blocking reagent.Beckman Coulter, Inc. / initiated 2023-05-17 / 987 kits

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)