# Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex
> **Product code: OPN** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5660
## Classification
- **FDA Product Code:** OPN
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.5660
- **Review panel:** IM
- **Medical specialty:** Immunology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OPN)
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