510(k) · Cleared
ClearedEL-Ana Profiles: Anti-Ribosomal Protein P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theratest Laboratories, Inc. · MQA Anti-Ribosomal P Antibodies
Cleared on Feb 6, 2003 after a 62-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 6, 2003
- Review
- 62 days
- Class
- Class II
- Product code
- MQA
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQA device
- #1 K202540 EliA Rib-Pscore 5.0 · 1 generation · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MQA devicesMQA Anti-Ribosomal P Antibodies: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQA
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MQA
Too few MQA 510(k)s in any year since 2007 to give a median.
Recalls per year · MQA
No recall names MQA since 2007.
Adverse event reports per year · MQA
No MAUDE report names MQA since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EL-ANA ProfilesTM is intended to measure autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), double-stranded DNA (dsDNA), Sm, RNP/Sm, SSA (Ro), SSB (La), Scl-70, Histones, Jo-1, Ribosomal Protein P, and Centromere. This system is intended as an aid in diagnosis of systemic lupus erythematosus and related rheumatic diseases.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K024151 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024151: EL-Ana Profiles: Anti-Ribosomal Protein P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024151
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026