510(k) Report

PMA · Approved

Approved

Truquant (R) BR (TM) Ria

P950011PMAApproved Mar 29, 1996395-day reviewClass III

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biomira, Inc. · MJB Antigen, Cancer 549

Approved on Mar 29, 1996 through premarket approval, which rests on the device’s own clinical evidence after a 395-day review. 3 later devices descend from it.

Decided
Mar 29, 1996
Review
395 days
Class
Class III
Product code
MJB
Recalls
None

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared1999: 1 descendant cleared1995200020052010201520202025
  1. This deviceP950011 Truquant (R) BR (TM) RiaBiomira, Inc. · 1996
  2. Descendant · cites it directly · 1 of its ownK963803 Centocor CA 15-3 Ria Model NO. 800-033Centocor, Inc. · 1997
  3. Descendant · 2 generations on · 0 of its ownK983690 Vitros Immunodiagnostic Products CA 15-3 Calibrators,Vitros…Ortho-Clinical Diagnostics, Inc. · 1999
  4. Descendant · cites it directly · 0 of its ownK970695 Acs:180 BR (Automated Chemiluminescence System for the Quantitation…Chiron Diagnostics Corp. · 1997

Most influential descendants

Showing 3 of 3 · See all
  • K963803Centocor CA 15-3 Ria Model NO. 800-033Centocor, Inc. · 1997 · cites it directly1descendant
  • K983690Vitros Immunodiagnostic Products CA 15-3 Calibrators,Vitros Immunodiagnostic Products CA…Ortho-Clinical Diagnostics, Inc. · 1999 · 2 generations on0descendants
  • K970695Acs:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen…Chiron Diagnostics Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)P950011Truquant (R) BR (TM) RiaBiomira, Inc.1996—
+1K963803Centocor CA 15-3 Ria Model NO. 800-033Centocor, Inc.1997—
+2K983690Vitros Immunodiagnostic Products CA 15-3 Calibrators,Vitros Immunodiagnostic…Ortho-Clinical Diagnostics, Inc.1999—
+1K970695Acs:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer…Chiron Diagnostics Corp.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199910
FIG. 1 — Lineage of P950011, 1996–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MJB? 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
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Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K963803Centocor CA 15-3 Ria Model NO. 800-033Centocor, Inc.19971
K970695Acs:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen…Chiron Diagnostics Corp.19970

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.

What does this lineage say?

  • Of its descendants, K963803 (Centocor, Inc., 1997) has gone furthest, with 1 descendant of its own.

How does its category compare?

All MJB devices

MJB Antigen, Cancer 549: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MJB

FDA has decided no MJB device since 2007.

Median 510(k) review, days · MJB

Too few MJB 510(k)s in any year since 2007 to give a median.

Recalls per year · MJB

No recall names MJB since 2007.

Adverse event reports per year · MJB

No MAUDE report names MJB since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

https://510kreport.com/device/P950011 · printed Nov 6, 2026

Cite this page

510(k) Report. “P950011: Truquant (R) BR (TM) Ria.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P950011

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026