510(k) · Cleared
ClearedElia (TM) Cardiolipin Iga Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia US, Inc. · MID System, Test, Anticardiolipin Immunological
Cleared on Dec 23, 2013 as substantially equivalent to K953366 (Inova Diagnostics, Inc., 1995) after a 186-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Dec 23, 2013
- Review
- 186 days
- Class
- Class II
- Product code
- MID
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953366 (1995). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K181329EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayPhadia AB · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953366 | Quanta Lite Iga Aca (HRP) | Inova Diagnostics, Inc. | 1995 | — |
| 0 (this device) | K131821 | Elia (TM) Cardiolipin Iga Immunoassay | Phadia US, Inc. | 2013 | — |
| +1 | K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay | Phadia AB | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 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? (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 |
|---|---|---|---|
| * | K953366 | Quanta Lite Iga Aca (HRP)Summary page 2…ipin IgA MID 11 866.5660 Substantial Equivalence to Quanta bite IgA ACA (l-IRP) K953366 Intended Use Statements of the New Device EliA Cardiolipin IgA is intended for the in vitro semi-quantita… | 1995 |
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 |
|---|---|---|---|
| K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay | 2018 | 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, K181329 (Phadia AB, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MID devicesMID System, Test, Anticardiolipin Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
EliA Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiolipin in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgA uses the EliA IgA method on the instruments Phadia 100. EliA…
Read the full statement (268 words)
EliA Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiolipin in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgA uses the EliA IgA method on the instruments Phadia 100.
EliA Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiiolipin in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgA uses the EliA IgA method on the instruments Phadia 250.
EliA APS Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to cardiolipin and β2-Glycoprotein I with Phadia 100 using the EliA IgG, IgM or IgA method.
EliA APS Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to cardiolipin and β2-Glycoprotein I with Phadia 250 using the EliA IgG, IgM or IgA method.
EliA IgG/IgM/IgA Negative Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of autoantibodies with Phadia 100 using the EliA IgG or IgM or IgA method.
EliA IgG/IgM/IgA Negative Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of autoantibodies with Phadia 250 using the EliA IgG or IgM or IgA method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131821: Elia (TM) Cardiolipin Iga Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131821
Report an extraction error
Are you the manufacturer?
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