510(k) · Cleared
ClearedImmulite Afp, Model Lkapi, LKAP5, Immulite 2000 Afp, Model L2KAP2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Cleared on Dec 7, 1998 as substantially equivalent to P820060 (Abbott Laboratories, 1983) after an 81-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Dec 7, 1998
- Review
- 81 days
- Class
- Class II
- Product code
- LOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P820060 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backP820060 Abbott Afp-Eia Diagnostic Kit for CancerAbbott Laboratories · 1983 · Recalled
- This deviceK983263 Immulite Afp, Model Lkapi, LKAP5, Immulite 2000 Afp, Model L2KAP2Diagnostic Products Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P820060 | Abbott Afp-Eia Diagnostic Kit for Cancer | Abbott Laboratories | 1983 | 2 |
| 0 (this device) | K983263 | Immulite Afp, Model Lkapi, LKAP5, Immulite 2000 Afp, Model L2KAP2 | Diagnostic Products Corp. | 1998 | — |
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 |
|---|---|---|---|
| * | P820060 | Abbott Afp-Eia Diagnostic Kit for CancerSummary page 1…0) Diagnostic Products Corporation (DPC) 5700 West 96" Street Los Angeles, CA 90045-5597 Euro/DPC - Not applicable DPC Registration number is 2017183 Abbott IMx® AFP (P820060) Description of Device: IMMULITE® AFP is a clinical device for use with the IMMULITE Automated Immuno- assay An… | 1983 |
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?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate P820060.
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?
IMMULITE AFP is for in vitro diagnostic use with the IMMULITE Analyzer — for the quantitative measurement of alpha-fetoprotein (AFP) in serum, as an aid in the management of patients with nonseminomatous testicular cancer.
IMMULITE 2000 AFP is for in vitro diagnostic use with the IMMULITE 2000 Analyzer — for the quantitative measurement of alpha-fetoprotein (AFP) in serum, as an aid in the management of patients with nonseminomatous testicular cancer.
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/K983263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983263: Immulite Afp, Model Lkapi, LKAP5, Immulite 2000 Afp, Model L2KAP2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983263
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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