510(k) · Cleared
ClearedAxis-Shield Anti-CCP
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 Aug 18, 2011 as substantially equivalent to K023285 (Axis-Shield Diagnostics, Ltd., 2002) after a 198-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Aug 18, 2011
- Review
- 198 days
- Class
- Class II
- Product code
- NHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023285 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK023285 Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) ElisaAxis-Shield Diagnostics, Ltd. · 2002 · Recalled
- This deviceK110296 Axis-Shield Anti-CCPAxis-Shield Diagnostics, Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023285 | Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) Elisa | Axis-Shield Diagnostics, Ltd. | 2002 | 1 |
| 0 (this device) | K110296 | Axis-Shield Anti-CCP | Axis-Shield Diagnostics, Ltd. | 2011 | — |
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 |
|---|---|---|---|
| * | K023285 | Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) ElisaSummary page 2…Page I of 4 Legally marketed device to which equivalency is claimed DIASTAT Tm Anti-GOP Assay (K023285) Intended Use of Device: The Axis-Shield Anti-GOP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELI… | 2002 |
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.
What does this lineage say?
- Its one ancestor has a recall.
- 4 other devices also cite its predicate K023285.
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. 2011, 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?
The Axis-Shield Anti-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 (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate). Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA), and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments.
For in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110296 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110296: Axis-Shield Anti-CCP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110296
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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