510(k) · Cleared
ClearedTheratest EL-Ana Profiles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theratest Laboratories, Inc. · LKP Anti-Sm Antibody, Antigen And Control
Cleared on Oct 7, 2005 after a 164-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 7, 2005
- Review
- 164 days
- Class
- Class II
- Product code
- LKP
- 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 LKP? 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 LKP device
- #1 K202067 EliA SmDP-Sscore 1.7 · 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 LKP devicesLKP Anti-Sm Antibody, Antigen And Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKP
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LKP
Too few LKP 510(k)s in any year since 2007 to give a median.
Recalls per year · LKP
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKP
No MAUDE report names LKP 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 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 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 Profiles TM is an in vitro diagnostic test for the detection and measurement of autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), double-stranded DNA (dsDNA), SmH R, RNP/Sm, SSA (Ro) HR, SSB (La) HR Histones, Scl-70, Jo-1 HR, Ribosomal Protein P, Centromere HR, and Chromatin (Nucleosomes). This test system is intended as an aid in diagnosis of systemic lupus erythematosus, Sjogren's syndrome, progressive systemic sclerosis (scleroderma), drug-induced lupus and polymyositis.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051066: Theratest EL-Ana Profiles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051066
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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