510(k) · Cleared
Recalled · 2005Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis-Shield Diagnostics, Ltd. · NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Cleared on Oct 9, 2002 after a 23-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it. It has been recalled once.
- Decided
- Oct 9, 2002
- Review
- 23 days
- Class
- Class II
- Product code
- NHX
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 5 citing it directly.
- This deviceK023285 Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) ElisaAxis-Shield Diagnostics, Ltd. · 2002
- Descendant · cites it directly · 1 of its ownK093954 Bioplex 2200 Anti-CCP Kit on the Bioplex 2200 Multi-Analyte…Bio-Rad Laboratories · 2010 · Recalled
- Descendant · cites it directly · 1 of its ownK061165 Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01Sweden Diagnostics (Us), Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK151799 EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid…Phadia AB · 2016
- Descendant · cites it directly · 0 of its ownK121576 Immulite 2000 Anti-CCP Igg AssaySiemens Healthcare Diagnostics, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK112810 Multi-Analyte Detection SystemsBio-Rad Laboratories · 2011 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K093954Bioplex 2200 Anti-CCP Kit on the Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories · 2010 · cites it directly1descendant
- K061165Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01Sweden Diagnostics (Us), Inc. · 2006 · cites it directly1descendant
- K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250…Phadia AB · 2016 · 2 generations on0descendants
- K121576Immulite 2000 Anti-CCP Igg AssaySiemens Healthcare Diagnostics, Inc. · 2013 · cites it directly0descendants
- K112810Multi-Analyte Detection SystemsBio-Rad Laboratories · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023285 | Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) Elisa | Axis-Shield Diagnostics, Ltd. | 2002 | — |
| +1 | K093954 | Bioplex 2200 Anti-CCP Kit on the Bioplex 2200 Multi-Analyte Detection System | Bio-Rad Laboratories | 2010 | 2 |
| +1 | K061165 | Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01 | Sweden Diagnostics (Us), Inc. | 2006 | 1 |
| +2 | K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive… | Phadia AB | 2016 | — |
| +1 | K121576 | Immulite 2000 Anti-CCP Igg Assay | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| +2 | K112810 | Multi-Analyte Detection Systems | Bio-Rad Laboratories | 2011 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 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? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093954 | Bioplex 2200 Anti-CCP Kit on the Bioplex 2200 Multi-Analyte Detection System | 2010 | 1 |
| K061165 | Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01 | 2006 | 1 |
| K121576 | Immulite 2000 Anti-CCP Igg Assay | 2013 | 0 |
| K110296 | Axis-Shield Anti-CCP | 2011 | 0 |
| K063347 | Axsym Anti-CCP Reagent, Standard Calibrator and Control Kits, Models 3L91-20, 3L91-01… | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 11, 2005 | Not classified | Z-0003-2007 | Other | The preservative sodium azide used in the Kit Negative Control (part number FCOM175) was at the wrong concentration - the Kit Negative Control contains 0.2% sodium azide rather than the intended 0.1%. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093954 (Bio-Rad Laboratories, 2010) has gone furthest, with 1 descendant 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 DiastatTMAnti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma. The test is intended to aid in the diagnosis of Rheumatoid Arthritis (RA) and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023285: Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023285
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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