510(k) · Cleared
Recalled · Class II · 2019Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol Anti-CCP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Cleared on Sep 11, 2008 as substantially equivalent to K052133 (Eurodiagnostica, 2005) after a 121-day review. Its family tree reaches back 1 generation to 2005. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 11, 2008
- Review
- 121 days
- Class
- Class II
- Product code
- NHX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052133 (2005). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK052133 Immunoscan RA Anti-CCP Test SystemEurodiagnostica · 2005
- This deviceK081338 Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol…Roche Diagnostics · 2008
- Descendant · cites it directly · 1 of its ownK121895 Elecsys HSV-2 Igg ImmunoassayRoche Diagnostics · 2012
- Descendant · cites it directly · 1 of its ownK120625 Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSVRoche Diagnostics · 2012
- Descendant · 2 generations on · 0 of its ownK220923 Elecsys HSV-1 IgG (08948844160)Roche Diagnostics · 2022
- Descendant · 2 generations on · 0 of its ownK220924 Elecsys HSV-2 IgG (08948887160)Roche Diagnostics · 2022
Most influential descendants
Showing 4 of 4 · See all- K121895Elecsys HSV-2 Igg ImmunoassayRoche Diagnostics · 2012 · cites it directly1descendant
- K120625Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSVRoche Diagnostics · 2012 · cites it directly1descendant
- K220923Elecsys HSV-1 IgG (08948844160)Roche Diagnostics · 2022 · 2 generations on0descendants
- K220924Elecsys HSV-2 IgG (08948887160)Roche Diagnostics · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052133 | Immunoscan RA Anti-CCP Test System | Eurodiagnostica | 2005 | — |
| 0 (this device) | K081338 | Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol Anti-CCP | Roche Diagnostics | 2008 | — |
| +1 | K121895 | Elecsys HSV-2 Igg Immunoassay | Roche Diagnostics | 2012 | — |
| +1 | K120625 | Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSV | Roche Diagnostics | 2012 | — |
| +2 | K220923 | Elecsys HSV-1 IgG (08948844160) | Roche Diagnostics | 2022 | — |
| +2 | K220924 | Elecsys HSV-2 IgG (08948887160) | Roche Diagnostics | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2022 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052133 | Immunoscan RA Anti-CCP Test SystemSummary page 2…arketed in the United States. (1) Elecsys Anti-CCP Immunoassay is equivalent to the Eurodiagnostica IMMUNOSCAN RA Anti-CCP Test Kit (K052133). Both products are intended for use in the semi-quantitative determination of human IgG anti… | 2005 |
What descends from it? (4)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 16, 2019 | Class II | Z-2362-2019 | Under Investigation by firm | Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples. |
| Jul 16, 2019 | Class II | Z-2361-2019 | Under Investigation by firm | Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2008, this device’s year, is highlighted.
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?
Immunoassay for the in vitro semi-quantitative determination of human IgG autoantibodies to cyclic citrullinated peptides in human serum and plasma. The results of the assay are intended to be used as an aid in the diagnosis of rheumatoid arthritis in combination with other clinical and laboratory findings.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Elecsys PreciControl Anti-CCP is used for quality control of the Elecsys Anti-CCP immunoassay on the Elecsys and cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081338 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081338: Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol Anti-CCP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081338
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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