510(k) · Cleared
ClearedEliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia AB · MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Cleared on Jun 25, 2018 as substantially equivalent to K112414 (Phadia US, Inc., 2012) and 1 other predicate after a 38-day review. Its family tree reaches back 2 generations to 2004.
- Decided
- Jun 25, 2018
- Review
- 38 days
- Class
- Class II
- Product code
- MSV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K040450 (2004). 4 ancestors in all, the oldest K953366 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK040450 Varelisa B2 Glycoprotein I Iga Antibodies, Models 18948 and 18996Pharmacia Deutschland GmbH · 2004
- 1 generation backK112414 Elia B2-Glycoprotein I Iga ImmunoassayPhadia US, Inc. · 2012
- This deviceK181329 EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA…Phadia AB · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040450 | Varelisa B2 Glycoprotein I Iga Antibodies, Models 18948 and 18996 | Pharmacia Deutschland GmbH | 2004 | — |
| −1 | K112414 | Elia B2-Glycoprotein I Iga Immunoassay | Phadia US, Inc. | 2012 | — |
| 0 (this device) | K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay | Phadia AB | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2013 | 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 MSV? 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 MSV device
- #1 K243979 Aptiva APS IgA Reagentscore 10.8 · 1 generation · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K112414 | Elia B2-Glycoprotein I Iga ImmunoassaySummary page 6…00/5000 006_A.6 510k Decision Summary Input-02 A.6-3 I. Device Description: The method-specific reagents are identical with K112414 (EliA β2-Glycoprotein I IgA) and K131821 (EliA Cardiolipin IgA), but are filled in containers specific for the Phadia 250… | 2012 |
| * | K131821 | Elia (TM) Cardiolipin Iga ImmunoassaySummary page 6…2 A.6-3 I. Device Description: The method-specific reagents are identical with K112414 (EliA β2-Glycoprotein I IgA) and K131821 (EliA Cardiolipin IgA), but are filled in containers specific for the Phadia 2500/5000 instrument. Each device consists of:… | 2013 |
| † | K062787 | Elia Celikey Iga Well, Model 14-5517-01; Elia Celiac Control, Model 83-1011-01 | 2006 |
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All MSV devicesMSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MSV
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · MSV
Too few MSV 510(k)s in any year since 2007 to give a median.
Recalls per year · MSV
No recall names MSV since 2007.
Adverse event reports per year · MSV
No MAUDE report names MSV since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
EliA ß2-Glycoprotein I IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to ß2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA) 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 ß2-Glycoprotein I IgA uses the EliA IgA method on the instrument Phadia…
Read the full statement (133 words)
EliA ß2-Glycoprotein I IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to ß2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA) 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 ß2-Glycoprotein I IgA uses the EliA IgA method on the instrument Phadia 2500/5000.
EliA Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA) 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 instrument Phadia 2500/5000.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181329: EliA B2-Glycoprotein I IgA Immunoassay, EliA 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/K181329
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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