Quanta Lite Aps/Pt Igg and Igm Elisa
FDA 510(k) K090755 · Inova Diagnostics, Inc.
510(k) numberK090755
Submission
- Device name
- Quanta Lite Aps/Pt Igg and Igm Elisa
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- March 20, 2009
- Decision date
- February 1, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- OPN – Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
For the detection of autoantibodies to phosphatidylserine (PS), prothrombin (PT), or phosphatidylserine/prothrombin (PS/PT) complex in human serum or plasma. To aid in the diagnosis of certain autoimmune thrombotic disorders such as anti-phospholipid syndrome and those secondary to systemic lupus erythematosus or other lupus-like diseases
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Questions and answers
When was Quanta Lite Aps/Pt Igg and Igm Elisa cleared by the FDA?
Quanta Lite Aps/Pt Igg and Igm Elisa (K090755) received a 510(k) decision of Substantially Equivalent on February 1, 2010, 318 days after the submission was received.
What is the product code of K090755?
The FDA product code is OPN – Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex, a Class II (moderate risk) device regulated under 21 CFR 866.5660.