510(k) · Cleared
Recalled · 2006EL-Acl Screen; EL-Acl Igm, Igg, Iga
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theratest Laboratories, Inc. · MID System, Test, Anticardiolipin Immunological
Cleared on Feb 7, 2006 after a 15-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Feb 7, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- MID
- Recalls
- 1
- 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2006 | Not classified | Z-0835-06 | Other | The specimen diluent contained in the kits was contaminated with a fungal growth. Also, a portion of kit lot 09055514 was shipped without the Data Sheet, part #201-204. |
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 TheraTest EL-aCL Tscreen and TheraTest EL-aCLc IgM, IgG, IgA are intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of autoantibodies in human serum directed against the phospholipid cardiolipin.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K060176 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060176: EL-Acl Screen; EL-Acl Igm, Igg, Iga.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060176
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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