Anti-Ribosomal P Antibodies
The Anti-Ribosomal P Antibodies test is an immunology in vitro diagnostic device used to detect antibodies against ribosomal P proteins in patient serum, which serve as a specific marker for systemic lupus erythematosus (SLE) and are associated with certain lupus-related neuropsychiatric manifestations. Classified as FDA Class 2 under 21 CFR 866.5100, it requires 510(k) premarket notification. The product code is MQA, and it is eligible for third-party 510(k) review.
Research product code MQA in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- MQA
- Device Class
- FDA class 2
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K202540 | EliA Rib-P | Sep 13, 2021 | Substantially Equivalent | Phadia AB |
| K024151 | EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P | Feb 06, 2003 | Substantially Equivalent | Theratest Laboratories, Inc. |
| K981237 | QUANTA LITE RIBOSOME P ELISA | Jun 05, 1998 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K950169 | RIBOSOMAL P EIA TEST SYSTEM | May 23, 1996 | Substantially Equivalent | Hogan & Hartson |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.