510(k) · Cleared

Cleared

Architect CA 15-3 Assay

K042732510(k) TraditionalCleared Dec 22, 200482-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

Fujirebio Diagnostics,Inc. · MOI System, Test, Immunological, Antigen, Tumor

Cleared on Dec 22, 2004 as substantially equivalent to K963926 (Abbott Laboratories, 1997) after an 82-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided: Dec 22, 2004
Review: 82 days
Class: Class II
Product code: MOI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K963926 (1997). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK963926 Axsym CA 15-3Abbott Laboratories · 1997 · Recalled
This deviceK042732 Architect CA 15-3 AssayFujirebio Diagnostics,Inc. · 2004
Descendant · cites it directly · 0 of its ownK192524 Lumipulse G CA15-3Fujirebio Diagnostics,Inc. · 2020

Most influential descendants

Showing 1 of 1 · See all

K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc. · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K963926	Axsym CA 15-3	Abbott Laboratories	1997	4
0 (this device)	K042732	Architect CA 15-3 Assay	Fujirebio Diagnostics,Inc.	2004	—
+1	K192524	Lumipulse G CA15-3	Fujirebio Diagnostics,Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0

FIG. 1 — Lineage of K042732, 1997–2020Source: 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.

Top candidate predicates for a new MOI device

#1 K240403 Access BR Monitorscore 7.9 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K963926	Axsym CA 15-3 Summary page 3 …5-3@ Assay (Proposed Device) (Predicate Device) K963926 Device Type In vitro diagnostic In vitro diagnostic Classification and Class II,MOI…	Abbott Laboratories	1997	4

Also cleared against K963926: 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
K192524	Lumipulse G CA15-3	Fujirebio Diagnostics,Inc.	2020	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 a recall.
Of its descendants, K192524 (Fujirebio Diagnostics,Inc., 2020) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K963926.

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 ARCHITECT CA 15-3 assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of DF3 defined antigen in human serum and plasma on the ARCHITECT i System. The ARCHITECT CA 15-3 assay is to be used as an aid in the management of Stage II and III breast cancer patients. Serial testing for patient CA 15-3 assay values should be used in conjunction with other clinical methods for monitoring breast cancer. The ARCHITECT…

Read the full statement (160 words)

The ARCHITECT CA 15-3 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DF3 defined antigen in human serum and plasma. Refer to the ARCHITECT CA 15-3 reagent package insert for additional information.

The ARCHITECT CA 15-3 Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DF3 defined antigen in human serum and plasma. Refer to the ARCHITECT CA 15-3 reagent package insert for additional information.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042732 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042732: Architect CA 15-3 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042732

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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