510(k) · Cleared
ClearedImmunoscan RA Anti-CCP Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eurodiagnostica · NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Cleared on Dec 12, 2005 after a 129-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Dec 12, 2005
- Review
- 129 days
- Class
- Class II
- Product code
- NHX
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK052133 Immunoscan RA Anti-CCP Test SystemEurodiagnostica · 2005
- Descendant · cites it directly · 4 of its ownK081338 Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol…Roche Diagnostics · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK121895 Elecsys HSV-2 Igg ImmunoassayRoche Diagnostics · 2012
- Descendant · 2 generations on · 1 of its ownK120625 Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSVRoche Diagnostics · 2012
- Descendant · 3 generations on · 0 of its ownK220923 Elecsys HSV-1 IgG (08948844160)Roche Diagnostics · 2022
- Descendant · 3 generations on · 0 of its ownK220924 Elecsys HSV-2 IgG (08948887160)Roche Diagnostics · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K081338Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol Anti-CCPRoche Diagnostics · 2008 · cites it directly4descendants
- K121895Elecsys HSV-2 Igg ImmunoassayRoche Diagnostics · 2012 · 2 generations on1descendant
- K120625Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSVRoche Diagnostics · 2012 · 2 generations on1descendant
- K220923Elecsys HSV-1 IgG (08948844160)Roche Diagnostics · 2022 · 3 generations on0descendants
- K220924Elecsys HSV-2 IgG (08948887160)Roche Diagnostics · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052133 | Immunoscan RA Anti-CCP Test System | Eurodiagnostica | 2005 | — |
| +1 | K081338 | Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol Anti-CCP | Roche Diagnostics | 2008 | 2 |
| +2 | K121895 | Elecsys HSV-2 Igg Immunoassay | Roche Diagnostics | 2012 | — |
| +2 | K120625 | Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSV | Roche Diagnostics | 2012 | — |
| +3 | K220923 | Elecsys HSV-1 IgG (08948844160) | Roche Diagnostics | 2022 | — |
| +3 | K220924 | Elecsys HSV-2 IgG (08948887160) | Roche Diagnostics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2022 | 2 | 0 |
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 NHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- Of its descendants, K081338 (Roche Diagnostics, 2008) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NHX devicesNHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · NHX
344in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHX
No recall names NHX since 2007.
Adverse event reports per year · NHX
3in 2025
MAUDE reports naming product code NHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 3 | 344 | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Immunoscan RA anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K052133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052133: Immunoscan RA Anti-CCP Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052133
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026