510(k) · Cleared

Recalled · Class II · 2018

Immulite BR-MA, Model #LKBR; Immulite 2000 BR-MA, Model #L2KBR

K013984510(k) TraditionalCleared Mar 28, 2002115-day reviewClass II21 CFR 866.6010Recalls 2

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

Diagnostic Products Corp. · MOI System, Test, Immunological, Antigen, Tumor

Cleared on Mar 28, 2002 as substantially equivalent to K964703 (Bayer Corp., 1997) after a 115-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it. It has been recalled 2 times.

Decided: Mar 28, 2002
Review: 115 days
Class: Class II
Product code: MOI
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K964703 (1997). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK964703 The CA 15-3 Assay for the Technicon Immuno 1 System (in Vitro…Bayer Corp. · 1997
This deviceK013984 Immulite BR-MA, Model #LKBR; Immulite 2000 BR-MA, Model #L2KBRDiagnostic Products Corp. · 2002
Descendant · cites it directly · 0 of its ownK233946 Immulite® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd. · 2024

Most influential descendants

Showing 1 of 1 · See all

K233946Immulite® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd. · 2024 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K964703	The CA 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System)	Bayer Corp.	1997	—
0 (this device)	K013984	Immulite BR-MA, Model #LKBR; Immulite 2000 BR-MA, Model #L2KBR	Diagnostic Products Corp.	2002	—
+1	K233946	Immulite® 2000 BR-MA	Siemens Healthcare Diagnostics Products, Ltd.	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2024	1	0

FIG. 1 — Lineage of K013984, 1997–2024Source: 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
*	K964703	The CA 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System) Summary page 2 …2 === Establishment Registration #: Euro/DPC — Not applicable DPC Registration number is 2017183 Substantially Equivalent Predicate Devices: Bayer Immuno 1™ CA 15-3™ (K964703) Chiron ACS 180 BR (CA27.29) Description of Device: IMMULITE BR-MA and IMMULITE 2000 BR-MA are clinical use devices intended fo…	Bayer Corp.	1997	—

Also cleared against K964703: 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
K233946	Immulite® 2000 BR-MA	Siemens Healthcare Diagnostics Products, Ltd.	2024	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 2, 2018	Class II	Z-1691-2018	Error in labeling	Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the…
Jan 2, 2018	Class II	Z-1677-2018	Error in labeling	Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K233946 (Siemens Healthcare Diagnostics Products, Ltd., 2024) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K964703.

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?

IMMULITE BR-MA For in vitro diagnostic use with IMMULITE analyzer — for the quantitative measurement of CA 15-3 antigen in human serum, as an aid in the detection of recurrence in previously treated stage II and stage III breast cancer patients, and in the management of metastatic breast cancer patients by monitoring disease progression or response to treatment. Serial testing for patient CA 15-3 values should be used in conjunction with other clinical…

Read the full statement (198 words)

IMMULITE BR-MA

For in vitro diagnostic use with IMMULITE analyzer — for the quantitative measurement of CA 15-3 antigen in human serum, as an aid in the detection of recurrence in previously treated stage II and stage III breast cancer patients, and in the management of metastatic breast cancer patients by monitoring disease progression or response to treatment. Serial testing for patient CA 15-3 values should be used in conjunction with other clinical methods used for detecting early recurrence in Stage II and Stage III disease and for monitoring response to treatment in patients with metastatic breast cancer.

IMMULITE 2000 BR-MA

For in vitro diagnostic use with IMMULITE 2000 analyzer — for the quantitative measurement of CA 15-3 antigen in human serum, as an aid in the detection of recurrence in previously treated stage II and stage III breast cancer patients, and in the management of metastatic breast cancer patients by monitoring disease progression or response to treatment. Serial testing for patient CA 15-3 values should be used in conjunction with other clinical methods used for detecting early recurrence in Stage II and Stage III disease and for monitoring response to treatment in patients with metastatic breast cancer.

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/K013984 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013984: Immulite BR-MA, Model #LKBR; Immulite 2000 BR-MA, Model #L2KBR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013984

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026