OPN

Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

Product code

OPN

Device name

Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

Device class

Class 2

21 CFR

21 CFR 866.5660

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).