510(k) · Cleared
ClearedAcs:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen 27.29)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chiron Corp. · MOI System, Test, Immunological, Antigen, Tumor
Cleared on Jul 10, 1998 after a 57-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jul 10, 1998
- Review
- 57 days
- Class
- Class II
- Product code
- MOI
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK981698 Acs:180 BR (Automated Chemiluminescence System for the Quantitation…Chiron Corp. · 1998
- Descendant · cites it directly · 1 of its ownK982680 Chiron Diagnostics Corporation Acs: Centaur BR ImmunoassayChiron Diagnostics Corp. · 1998 · Recalled
- Descendant · 2 generations on · 0 of its ownK193489 ADVIA Centaur BRSiemens Healthcare Diagnostics, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981698 | Acs:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer… | Chiron Corp. | 1998 | — |
| +1 | K982680 | Chiron Diagnostics Corporation Acs: Centaur BR Immunoassay | Chiron Diagnostics Corp. | 1998 | 9 |
| +2 | K193489 | ADVIA Centaur BR | Siemens Healthcare Diagnostics, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2020 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | — | ACS:180 BR Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982680 | Chiron Diagnostics Corporation Acs: Centaur BR Immunoassay | 1998 | 1 |
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, K982680 (Chiron Diagnostics Corp., 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MOI devicesMOI System, Test, Immunological, Antigen, Tumor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOI
2in 2024
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOI
6in 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 Chiron Diagnostics ACS:180 BR is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems. The test is intended for use as an aid in monitoring patients previously treated for Stage Il or Stage [l breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in…
Read the full statement (119 words)
The Chiron Diagnostics ACS:180 BR is an in vitro diagnostic test for the
quantitative serial determination of cancer antigen CA 27.29 in human serum
using the Chiron Diagnostics ACS:180® Automated Chemiluminescence
Systems. The test is intended for use as an aid in monitoring patients previously
treated for Stage Il or Stage [l breast cancer. Serial testing for CA 27.29 in the
serum of patients who are clinically free of disease should be used in conjunction
with other clinical methods used for the early detection of cancer recurrence. The
test is also intended for use as an aid in the mamagement of breast cancer
patients with metastatic disease by monitoring the progression or regression of
disease in response to treatment.
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/K981698 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981698: Acs:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen 27.29).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981698
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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