510(k) · Cleared
ClearedAcl/Aps Facs Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Louisville Apl Diagnostics, Inc. · MID System, Test, Anticardiolipin Immunological
Cleared on Mar 18, 1999 after a 121-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 18, 1999
- Review
- 121 days
- Class
- Class II
- Product code
- MID
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MID? 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 MID device
- #1 K223093 Aptiva APS IgG Reagent; Aptiva APS IgM Reagentscore 8.8 · 2 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 MID devicesMID System, Test, Anticardiolipin Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MID
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MID
234in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MID
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MID
1in 2023
MAUDE reports naming product code MID, 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 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 234 | 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 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The aCl/aPS®FACS Kit is and assay for the semi-quantitative determination of antiphospholipid (anticardiolipin-aCL and antiphosphatidylserine-aPS) antibodies to be used in the aid of the diagnosis of the Antiphospholipid Syndrome (APS). APS is defined as a disorder of recurrent thrombosis, pregnancy loss and/or thrombocytopenia with persistent positive antiphospholipid tests.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984102 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984102: Acl/Aps Facs Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984102
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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