510(k) · Cleared
ClearedCardiolipin Autoantibody Immunological Test System
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 Jun 7, 2010 as substantially equivalent to K020752 (Pharmacia Deutschland GmbH, 2002) and 3 other predicates after a 350-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.
- Decided
- Jun 7, 2010
- Review
- 350 days
- Class
- Class II
- Product code
- MID
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K020752 (2002). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK020752 Varelisa Cardiolipin Igg Antibodies, Models 15548 & 15596Pharmacia Deutschland GmbH · 2002
- This deviceK091845 Cardiolipin Autoantibody Immunological Test SystemPhadia US, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK151799 EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid…Phadia AB · 2016
Most influential descendants
Showing 1 of 1 · See all- K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250…Phadia AB · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020752 | Varelisa Cardiolipin Igg Antibodies, Models 15548 & 15596 | Pharmacia Deutschland GmbH | 2002 | — |
| 0 (this device) | K091845 | Cardiolipin Autoantibody Immunological Test System | Phadia US, Inc. | 2010 | — |
| +1 | K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive… | Phadia AB | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (4)
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 |
|---|---|---|---|
| * | K020752 | Varelisa Cardiolipin Igg Antibodies, Models 15548 & 15596Summary page 2…11 866.5660 MSV i 866.5660 MSV II 866.5660 Y I 862.1660 Substantial Equivalence to Varelisa Cardiolipin LgG Antibodies K020752 Varelisa Cardiolipin 1gM Antibodies K020758 Varelisa B2-Glycoprotein I IgG Antibodies… | 2002 |
| * | K020758 | Varelisa Cardiolipin Igm Antibodies, Models 15648 & 15696Summary page 2…Substantial Equivalence to Varelisa Cardiolipin LgG Antibodies K020752 Varelisa Cardiolipin 1gM Antibodies K020758 Varelisa B2-Glycoprotein I IgG Antibodies K040449 Varelisa 132-Glycoprotein I 1gM Antibodies… | 2002 |
| * | K040449 | Varelisa B2 Glycoprotein I Igg Antibodies, Models 18748 and 18796Summary page 2…K020752 Varelisa Cardiolipin 1gM Antibodies K020758 Varelisa B2-Glycoprotein I IgG Antibodies K040449 Varelisa 132-Glycoprotein I 1gM Antibodies K04045 1 Intended Use Statements of… | 2004 |
| * | K040451 | Varelisa B2 Glycoprotein I Igm Antibodies, Models 18848 and 18896Summary page 2…K020758 Varelisa B2-Glycoprotein I IgG Antibodies K040449 Varelisa 132-Glycoprotein I 1gM Antibodies K04045 1 Intended Use Statements of the New Devices 1) EliA Cardiolipin LgG is intended for the in vitro semi… | 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 |
|---|---|---|---|
| K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250… | 2016 | 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?
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K151799 (Phadia AB, 2016) 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. 2010, 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 IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgG uses the EliA IgG method on the instrument Phadia 100. EliA…
Read the full statement (602 words)
EliA Cardiolipin IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgG uses the EliA IgG method on the instrument Phadia 100.
EliA Cardiolipin IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgG uses the EliA IgG method on the instrument Phadia 250.
EliA Cardiolipin IgM is intended for the in vitro semi-quantitative measurement of IgM antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgM uses the EliA IgM method on the instrument Phadia 100.
EliA Cardiolipin IgM is intended for the in vitro semi-quantitative measurement of IgM antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgM uses the EliA IgM method on the instrument Phadia 250.
EliA β2-Glycoprotein I IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to β2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA β2-Glycoprotein I IgG uses the EliA IgG method on the instrument Phadia 100.
EliA β2-Glycoprotein I IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to β2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA β2-Glycoprotein I IgG uses the EliA IgG method on the instrument Phadia 250.
EliA β2-Glycoprotein I IgM is intended for the in vitro semi-quantitative measurement of IgM antibodies directed to β2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA β2-Glycoprotein I IgM uses the EliA IgM method on the instrument Phadia 100.
EliA β2-Glycoprotein I IgM is intended for the in vitro semi-quantitative measurement of IgM antibodies directed to β2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA β2-Glycoprotein I IgM uses the EliA IgM method on the instrument 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 or IgM 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 or IgM method.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K091845 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091845: Cardiolipin Autoantibody Immunological Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091845
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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