# K965141: Truquant BR Ria

- Pathway: 510(k) (Traditional)
- Applicant: Biomira USA, Inc.
- Decided: Oct 31, 1997 after 312 days
- Product code: MOI (System, Test, Immunological, Antigen, Tumor)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Truquant® BR™ Ria: named in the summary without a submission number

## Most influential descendants
- K980190: Acs 180 BR (Automated Chemiluminescence System) (1998), 0 descendants of its own

## Indications for use
TRUQUANT® BR™ RIA is an in vitro diagnostic device indicated for the quantitative determination of CA 27.29 antigen in serum or EDTA plasma of patients previously treated for stage II or stage III breast cancer. Serial testing for CA 27.29 antigen with TRUQUANT® BR™ RIA in patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of recurrence. In addition, quantitation of CA 27.29 antigen in conjunction with other clinical methods can be used as an aid in monitoring response to therapy in patients with stage IV breast cancer.

Source page: https://510kreport.com/device/K965141
Methodology: https://510kreport.com/methodology