510(k) · Cleared
ClearedElia B2-Glycoprotein I Iga Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia US, Inc. · MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Cleared on Jun 22, 2012 as substantially equivalent to K040450 (Pharmacia Deutschland GmbH, 2004) after a 305-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.
- Decided
- Jun 22, 2012
- Review
- 305 days
- Class
- Class II
- Product code
- MSV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040450 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK040450 Varelisa B2 Glycoprotein I Iga Antibodies, Models 18948 and 18996Pharmacia Deutschland GmbH · 2004
- This deviceK112414 Elia B2-Glycoprotein I Iga ImmunoassayPhadia US, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK181329 EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA…Phadia AB · 2018
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 | K040450 | Varelisa B2 Glycoprotein I Iga Antibodies, Models 18948 and 18996 | Pharmacia Deutschland GmbH | 2004 | — |
| 0 (this device) | K112414 | Elia B2-Glycoprotein I Iga Immunoassay | Phadia US, Inc. | 2012 | — |
| +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 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? (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 |
|---|---|---|---|
| * | K040450 | Varelisa B2 Glycoprotein I Iga Antibodies, Models 18948 and 18996Summary page 2…ycoprotein I IgA MSV 11 866.5660 Substantial Equivalence to Varelisa 12-Glycoprotein I IgA Antibodies K040450 Intended Use Statement of' the New Device EliA 132-Glycoprotein I IgA is intended for the in vitro semni… | 2004 |
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 MSV devicesMSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 B2-Glycoprotein I IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to B2-Glycoprotein I 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 B2-Glycoprotein I IgA uses the EliA IgA method on the instruments Phadia 100 and Phadia 250.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112414: Elia B2-Glycoprotein I 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/K112414
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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