510(k) · Cleared
ClearedAfp Assay for the Advia Integrated Modular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Diagnostics Corp. · LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Cleared on Oct 1, 2002 after a 203-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 1, 2002
- Review
- 203 days
- Class
- Class II
- Product code
- LOJ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (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 |
|---|---|---|---|
| * | — | Immuno 1 Named without a submission number |
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.
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?
The Buyer ADVIA®IMSTM AFP assay is an in vitro diagnostic device intended to quantitatively measure a-fetoprotein (AFP) in human serum on the Bayer ADVIA IMS system as an aid in the management of nonseminomatous testicular cancer. AFP values obtained using the Bayer ADVIA IMS assay method must be interpreted in conjunction with all other available clinical and laboratory data before a medical decision is determined. AFP testing is not recommended as a screening procedure to detect cancer in the general population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020807: Afp Assay for the Advia Integrated Modular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020807
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026