Elia(Tm) Cardiolipin Iga Immunoassay
FDA 510(k) K131821 · Phadia US, Inc.
510(k) numberK131821
Submission
- Device name
- Elia(Tm) Cardiolipin Iga Immunoassay
- Applicant
- Phadia US, Inc.
Portage, MI, US - Received
- June 20, 2013
- Decision date
- December 23, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MID – System, Test, Anticardiolipin Immunological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
Other 510(k)s with product code MID
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|---|---|---|---|
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM ReagentMID · Traditional | Inova Diagnostics, Inc. | 12/17/2024SE |
| K130528 | Bioplex 2200 Apls IgmMID · Traditional | Bio-Rad Laboratories | 10/21/2013SE |
| K120817 | Quanta Flash Acl Lga, Quanta Flash B2GP1 IgaMID · Traditional | Inova Diagnostics, Inc. | 02/26/2013SE |
| K113020 | Immulisa Enhanced (TM) Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (Aca) ElisasMID · Traditional | Immco Diagnostics, Inc. | 10/25/2012SE |
| K103834 | Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control SetsMID · Traditional | Bio-Rad Laboratories | 03/30/2012SE |
| K102425 | Zeus Elisa Cardiolipin Igg/Igm/Iga Test SystemMID · Traditional | Zeus Scientific, Inc. | 12/12/2011SE |
| K091845 | Cardiolipin Autoantibody Immunological Test SystemMID · Traditional | Phadia US, Inc. | 06/07/2010SE |
| K092181 | Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm ControlsMID · Traditional | Instrumentation Laboratory CO | 03/11/2010SE |
| K060176 | El-Acl Screen; El-Acl Igm, Igg, IgaMID · Special | Theratest Laboratories, Inc. | 02/07/2006SE |
| K040463 | Aeskulisa Cardiolipin AgmMID · Traditional | Aesku, Inc. | 05/12/2004SE |
More from Aesku, Inc.
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| K141375 | Elia M2; Immunoassay, Positive Control 100, Positive Control 250DBM · Traditional | 02/13/2015SE |
| K140225 | Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/Gbm…MOB · Traditional | 10/27/2014SE |
| K132631 | Eia SMDP ImmunoassayLKP · Traditional | 08/29/2014SE |
| K122197 | Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige…DHB · Traditional | 08/28/2013SE |
| K113841 | Immunocap Allergen Components BundleDHB · Traditional | 09/13/2012SE |
| K112414 | Elia B2-GLYCOPROTEIN I Iga ImmunoassayMSV · Traditional | 06/22/2012SE |
| K111919 | Immunocap Specific Ige Allergen Bundle, 12 Allergen ComponentsDHB · Traditional | 12/22/2011SE |
| K102673 | Rheumatoid Factor Immunological Test SystemDHR · Traditional | 09/30/2011SE |
| K093459 | Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models 14-5538-01…MST · Traditional | 08/13/2010SE |
| K091845 | Cardiolipin Autoantibody Immunological Test SystemMID · Traditional | 06/07/2010SE |
Questions and answers
When was Elia(Tm) Cardiolipin Iga Immunoassay cleared by the FDA?
Elia(Tm) Cardiolipin Iga Immunoassay (K131821) received a 510(k) decision of Substantially Equivalent on December 23, 2013, 186 days after the submission was received.
What is the product code of K131821?
The FDA product code is MID – System, Test, Anticardiolipin Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5660.