DeviceClearance

Product code OPN— Immunology

QUANTA LITE APS/PT IGG AND IGM ELISA

Classification name
Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex
Device class
Class 2
Regulation
21 CFR 866.5660
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

FDA classification definition

“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”

— U.S. Food and Drug Administration, device classification record for product code OPN under 21 CFR 866.5660, via openFDA

Market context for product code OPN

FDA has cleared 1 device under product code OPN, all in 2010, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OPN

Recent clearances under product code OPN

Data sourced from openFDA. This site is unofficial and independent of the FDA.