510(k) Report

510(k) · Cleared

Cleared

The CA 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System)

K964703510(k) TraditionalCleared Dec 1, 1997374-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

Bayer Corp. · MOI System, Test, Immunological, Antigen, Tumor

Cleared on Dec 1, 1997 after a 374-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.

Decided
Dec 1, 1997
Review
374 days
Class
Class II
Product code
MOI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 2 descendants cleared2019: 1 descendant cleared2011: 1 descendant cleared2024: 1 descendant cleared2012: 1 descendant cleared1995200020052010201520202025
  1. This deviceK964703 The CA 15-3 Assay for the Technicon Immuno 1 System (in Vitro…Bayer Corp. · 1997
  2. Descendant · cites it directly · 3 of its ownK012357 CA 15-3 Assay for the Advia Centaur SystemBayer Diagnostics Corp. · 2002
  3. Descendant · 2 generations on · 1 of its ownK100344 Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista…Siemens Healthcare Diagnostics · 2011 · Recalled
  4. Descendant · cites it directly · 1 of its ownK013984 Immulite BR-MA, Model #LKBR; Immulite 2000 BR-MA, Model #L2KBRDiagnostic Products Corp. · 2002 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK233946 Immulite® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd. · 2024
  6. Descendant · 2 generations on · 0 of its ownK192777 ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc. · 2019

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2002: 22011: 12012: 12019: 12024: 1
2002high 2 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 6 · See all
  • K012357CA 15-3 Assay for the Advia Centaur SystemBayer Diagnostics Corp. · 2002 · cites it directly3descendants
  • K100344Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator…Siemens Healthcare Diagnostics · 2011 · 2 generations on1descendant
  • K013984Immulite BR-MA, Model #LKBR; Immulite 2000 BR-MA, Model #L2KBRDiagnostic Products Corp. · 2002 · cites it directly1descendant
  • K233946Immulite® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd. · 2024 · 2 generations on0descendants
  • K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K964703The CA 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System)Bayer Corp.1997—
+1K012357CA 15-3 Assay for the Advia Centaur SystemBayer Diagnostics Corp.2002—
+2K100344Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7…Siemens Healthcare Diagnostics20111
+1K013984Immulite BR-MA, Model #LKBR; Immulite 2000 BR-MA, Model #L2KBRDiagnostic Products Corp.20022
+2K233946Immulite® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd.2024—
+2K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
201110
201210
201910
202410
FIG. 1 — Lineage of K964703, 1997–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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. #1 K240403 Access BR Monitorscore 7.9 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Biomira TRUQUANT® BR™ RIA
Named without a submission number
—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K012357CA 15-3 Assay for the Advia Centaur SystemBayer Diagnostics Corp.20023
K013984Immulite BR-MA, Model #LKBR; Immulite 2000 BR-MA, Model #L2KBRDiagnostic Products Corp.20021

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, K012357 (Bayer Diagnostics Corp., 2002) has gone furthest, with 3 descendants of its own.

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

2007: 12011: 12018: 22019: 12020: 22024: 2
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

2007: 12012: 2
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

2007: 22008: 32009: 32010: 222011: 32012: 42013: 32014: 522015: 282016: 52017: 72018: 12019: 52020: 112021: 162022: 162023: 62024: 52025: 6
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—12
20080—03
20090—03
20100—022
20111—03
20120—24
20130—03
20140—052
20150—028
20160—05
20170—07
20182—01
20191—05
20202—011
20210—016
20220—016
20230—06
20242—05
20250—06
20260—0—

What is it indicated for?

The Bayer Immuno 1™ CA 15-3™ Assay is an in vitro, diagnostic, solid phase immunoassay intended to quantitatively measure CA 15-3 Assay values in human serum on the Bayer Immuno 1 system. When used in conjunction with other clinical and diagnostic procedures, serial testing with the CA 15-3 Assay is useful for monitoring the course of disease and therapy in metastatic breast cancer patients, and for detection of recurrence in previously treated Stage II, with greater than 2 positive lymph nodes, or Stage III breast cancer patients.

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

More from Bayer Corp.

96 FDA decisions under this applicant name. See the company

  • K024062Ascensia Breeze Blood Glucose MeterBayer Corp. · 2003
  • K023944Bayer Diagnostics Clinitest Pregnancy TestBayer Corp. · 2003
  • K024017Bayer Advia Centaur Her-2/Neu AssayBayer Corp. · 20031 recall
  • K024234Ascensia Glucofacts; Ascensia Glucofacts ProfessionalBayer Corp. · 2003
  • K022288Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module SystemBayer Corp. · 2002

Recent decisions in MOI

The MOI category page

  • K240403Access BR MonitorBeckman Coulter, Inc. · 2024
  • K233946Immulite® 2000 BR-MASiemens Healthcare Diagnostics Products, Ltd. · 2024
  • K192524Lumipulse G CA15-3Fujirebio Diagnostics,Inc. · 2020
  • K193489ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc. · 2020
  • K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc. · 2019

https://510kreport.com/device/K964703 · printed Nov 5, 2026

Cite this page

510(k) Report. “K964703: The CA 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964703

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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