510(k) · Cleared
ClearedAcs:Centaur Afp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chiron Diagnostics Corp. · LOQ Device, General Purpose, Hematology
Cleared on Jul 7, 1998 as substantially equivalent to P920030 (Bayer Healthcare, LLC, 1998) after a 64-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Jul 7, 1998
- Review
- 64 days
- Class
- Class II
- Product code
- LOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P920030 (1998). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K020806Acs:180 & Advia Centaur Afp ImmunoassayBayer Corp. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P920030 | Ciba Corning Acs Psa Immunoassay | Bayer Healthcare, LLC | 1998 | — |
| 0 (this device) | K981592 | Acs:Centaur Afp | Chiron Diagnostics Corp. | 1998 | — |
| +1 | K020806 | Acs:180 & Advia Centaur Afp Immunoassay | Bayer Corp. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 LOQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | P920030 | Ciba Corning Acs Psa ImmunoassaySummary page 1…Reclassified to Class ll, classification number unknown 3. Predicate Device Information Name: _ ACS:180 AFP Immunoassay Manufacturer: Chiron Diagnostics 510(k) Number: P920030 (note reclassified to class Il) 4. Device Description The Chiron Diagnostics ACS:Centaur AFP immunoassay is a two-site immunoas… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020806 | Acs:180 & Advia Centaur Afp Immunoassay | 2002 | 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 no recall.
- Of its descendants, K020806 (Bayer Corp., 2002) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LOQ devicesLOQ Device, General Purpose, Hematology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOQ
FDA has decided no LOQ device since 2007.
Median 510(k) review, days · LOQ
Too few LOQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LOQ
No recall names LOQ since 2007.
Adverse event reports per year · LOQ
56in 2011
MAUDE reports naming product code LOQ, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 25 |
| 2011 | 0 | — | 0 | 56 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ACS:Centaur AFP Immunoassay is 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 Chiron Diagnostics ACS:Centaur Automated Chemiluminescence 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/K981592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981592: Acs:Centaur Afp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981592
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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