510(k) · Cleared

Cleared

Centocor CA 15-3 Ria Model NO. 800-033

K963803510(k) TraditionalCleared May 23, 1997242-day reviewClass II21 CFR 866.6010

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

Centocor, Inc. · MOI System, Test, Immunological, Antigen, Tumor

Cleared on May 23, 1997 as substantially equivalent to P950011 (Biomira, Inc., 1996) after a 242-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: May 23, 1997
Review: 242 days
Class: Class II
Product code: MOI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to P950011 (1996). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backP950011 Truquant (R) BR (TM) RiaBiomira, Inc. · 1996
This deviceK963803 Centocor CA 15-3 Ria Model NO. 800-033Centocor, Inc. · 1997
Descendant · cites it directly · 0 of its ownK983690 Vitros Immunodiagnostic Products CA 15-3 Calibrators,Vitros…Ortho-Clinical Diagnostics, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all

K983690Vitros Immunodiagnostic Products CA 15-3 Calibrators,Vitros Immunodiagnostic Products CA…Ortho-Clinical Diagnostics, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P950011	Truquant (R) BR (TM) Ria	Biomira, Inc.	1996	—
0 (this device)	K963803	Centocor CA 15-3 Ria Model NO. 800-033	Centocor, Inc.	1997	—
+1	K983690	Vitros Immunodiagnostic Products CA 15-3 Calibrators,Vitros Immunodiagnostic…	Ortho-Clinical Diagnostics, Inc.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K963803, 1996–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in MOI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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#1 K240403 Access BR Monitorscore 7.9 · 3 generations · no Class I recall
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	P950011	Truquant (R) BR (TM) Ria Summary page 2 …651 0oz -6100 Substantial Equivalence The Centocor CA 15-3 RIA has been found to be substantially equivalent to ~Biomira Diagnostic’s TRUQUANT BR RIA, P950011, approved by the Food and Drug Administration on March 29, 1996. Device Description: The Centocor CA 15-3 RIA is an in vitro di…	Biomira, Inc.	1996	—

Also cleared against P950011: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K983690	Vitros Immunodiagnostic Products CA 15-3 Calibrators,Vitros Immunodiagnostic Products CA…	Ortho-Clinical Diagnostics, Inc.	1999	0

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?

Its one ancestor has no recall.
Of its descendants, K983690 (Ortho-Clinical Diagnostics, Inc., 1999) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate P950011.

How does its category compare?

All MOI devices

MOI System, Test, Immunological, Antigen, Tumor: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MOI

2in 2024

2007high 2 (2018) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOI

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

Recalls per year · MOI

2in 2012

2007high 2 (2012) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MOI

6in 2025

2007high 52 (2014) · low 1 (2018)2025

MAUDE reports naming product code MOI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	1	2
2008	0	—	0	3
2009	0	—	0	3
2010	0	—	0	22
2011	1	—	0	3
2012	0	—	2	4
2013	0	—	0	3
2014	0	—	0	52
2015	0	—	0	28
2016	0	—	0	5
2017	0	—	0	7
2018	2	—	0	1
2019	1	—	0	5
2020	2	—	0	11
2021	0	—	0	16
2022	0	—	0	16
2023	0	—	0	6
2024	2	—	0	5
2025	0	—	0	6
2026	0	—	0	—

What is it indicated for?

The Centocor CA 15-3 RIA is an in vitro test for the quantitative determination of DF3 antibody-defined antigen, encoded by the MUC 1 gene, in serum and plasma. Serial test results obtained with the Centocor CA 15-3 RIA, are useful in the early detection of recurrence in patients previously treated for stage II or stage ITI breast cancer, who are clinically free of discase. Early detection of recurrence cannot be readily accomplished by routine clinical…

Read the full statement (134 words)

The Centocor CA 15-3 RIA is an in vitro test for the quantitative determination of DF3 antibody-defined antigen, encoded by the MUC 1 gene, in serum and plasma.

Serial test results obtained with the Centocor CA 15-3 RIA, are useful in the early detection of recurrence in patients previously treated for stage II or stage ITI breast cancer, who are clinically free of discase. Early detection of recurrence cannot be readily accomplished by routine clinical or diagnostic studies alone. The use of a circulating serum tumor marker assay, such as Centocor CA 15-3 RIA, can be useful in the identification of these patients. The Centocor CA 15-3 RIA should be used in conjunction with all relevant information derived from diagnostic tests, physical examination and full medical history, in accordance with appropriate patient management procedures

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K963803 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963803: Centocor CA 15-3 Ria Model NO. 800-033.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963803

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026