# P950011: Truquant (R) BR (TM) Ria

- Pathway: PMA
- Applicant: Biomira, Inc.
- Decided: Mar 29, 1996 after 395 days
- Product code: MJB (Antigen, Cancer 549)
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K963803: Centocor CA 15-3 Ria Model NO. 800-033 (1997), 1 descendant of its own
- K983690: Vitros Immunodiagnostic Products CA 15-3 Calibrators,Vitros Immunodiagnostic Products CA 15-3 Reagent Pack (1999), 0 descendants of its own
- K970695: Acs:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen 27.29) (1997), 0 descendants of its own

Source page: https://510kreport.com/device/P950011
Methodology: https://510kreport.com/methodology