QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
FDA 510(k) K152875 · Inova Diagnostics, Inc.
510(k) numberK152875
Submission
- Device name
- QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- September 30, 2015
- Decision date
- December 21, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSV – System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
Other 510(k)s with product code MSV
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| K243979 | Aptiva APS IgA ReagentMSV · Traditional | Inova Diagnostics, Inc. | 02/06/2026SE |
| K181329 | EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayMSV · Traditional | Phadia AB | 06/25/2018SE |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA…MSV · Traditional | Immco Diagnostics, Inc. | 06/19/2017SE |
| K141274 | Quanta Flash ¿2GP1-DOMAIN1; Controls, Hemosil Acustar ANTI-¿2GPI DOMAIN1; Controls.MSV · Traditional | Inova Diagnostics, Inc. | 02/13/2015SE |
| K112414 | Elia B2-GLYCOPROTEIN I Iga ImmunoassayMSV · Traditional | Phadia US, Inc. | 06/22/2012SE |
| K091556 | Hemosil Acustar ANTI-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm ControlsMSV · Traditional | Instrumentation Laboratory CO | 05/21/2010SE |
| K092757 | Theratest EL-BETA2GPI (Igm-Igg-Iga), Theratest EL--BETA2GPI SCRMSV · Special | Thera-Test Laboratories, Inc. | 10/09/2009SE |
| K072032 | Igg Anti-Atherox Test KitMSV · Traditional | Corgenix, Inc. | 04/04/2008SE |
| K062217 | Aeskulska BETA2-GLYCO-AMSV · Traditional | Aesku, Inc. | 12/13/2006SE |
| K040452 | Varelisa B2 Glycoprotein I Antibodies Screen, Models 19048 and 19096MSV · Traditional | Pharmacia Deutschland GmbH | 05/11/2004SE |
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Questions and answers
When was QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls cleared by the FDA?
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls (K152875) received a 510(k) decision of Substantially Equivalent on December 21, 2015, 82 days after the submission was received.
What is the product code of K152875?
The FDA product code is MSV – System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi), a Class II (moderate risk) device regulated under 21 CFR 866.5660.