510(k) · Cleared
ClearedAcs:180 & Advia Centaur Afp Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Cleared on Mar 27, 2002 as substantially equivalent to P930036 (Siemens Healthcare Diagnostics, Inc., 1995) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Mar 27, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- LOJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P920030 (1998). 3 ancestors in all, the oldest P930036 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P920030 | Ciba Corning Acs Psa Immunoassay | Bayer Healthcare, LLC | 1998 | — |
| −1 | K981592 | Acs:Centaur Afp | Chiron Diagnostics Corp. | 1998 | — |
| 0 (this device) | K020806 | Acs:180 & Advia Centaur Afp Immunoassay | Bayer Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 LOJ? 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 LOJ device
- #1 K220176 Elecsys AFPscore 4.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | P930036 | Advia Centaur Afp Reagents and CalibratorsSummary page 1…ntigen Immunological Test System Predicate Device Information Name: ACS:180 & ADVIA Centaur AFP Immunoassay Manufacturer: Bayer Diagnostics 510(k) Number: ACS:180 - P930036 (reclassified to class ) ADVIA Centaur - K981592 Device Description The Bayer Diagnostics ACS:180 & ADVIA Centaur AFP immunoass… | 1995 |
| * | K981592 | Acs:Centaur AfpSummary page 1…ce Information Name: ACS:180 & ADVIA Centaur AFP Immunoassay Manufacturer: Bayer Diagnostics 510(k) Number: ACS:180 - P930036 (reclassified to class ) ADVIA Centaur - K981592 Device Description The Bayer Diagnostics ACS:180 & ADVIA Centaur AFP immunoassay is a two-site immunoassay using direct chemilu… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All LOJ devicesLOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOJ
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LOJ
Too few LOJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LOJ
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOJ
5in 2025
MAUDE reports naming product code LOJ, 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 | 0 | — | 1 | 1 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 2 | — | 1 | 7 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 18 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the quantitative determination of alpha-fetoprotein (AFP) in the following:
human serum, as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the Bayer Diagnostics ACS:180 Automated Chemiluminescence System or the ADVIA Centaur System.
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/K020806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020806: Acs:180 & Advia Centaur Afp Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020806
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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