510(k) · Cleared
ClearedAxsym Anti-CCP Reagent, Standard Calibrator and Control Kits, Models 3L91-20, 3L91-01 and 3L91-10
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 Mar 20, 2007 as substantially equivalent to K023285 (Axis-Shield Diagnostics, Ltd., 2002) after a 134-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Mar 20, 2007
- Review
- 134 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 deviceK063347 Axsym Anti-CCP Reagent, Standard Calibrator and Control Kits, Models…Axis-Shield Diagnostics, Ltd. · 2007
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) | K063347 | Axsym Anti-CCP Reagent, Standard Calibrator and Control Kits, Models 3L91-20… | Axis-Shield Diagnostics, Ltd. | 2007 | — |
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…Classification: Class I Classification Panel: Clinical Chemistry Product Code: JJX Legally marketed device to which equivalency is claimed: DIASTATT M Anti-CCP Assay (K023285) Intended Use of Device: AxSYM® Anti-CCP is a Microparticle Enzyme Immunoassay (MEIA) for the semi- quantitative determinatio… | 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. 2007, 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?
Reagents AxSYM® Anti-CCP is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma on the AxSYM System. 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…
Read the full statement (163 words)
Reagents
AxSYM® Anti-CCP is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma on the AxSYM System. 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 multicriterion diagnostic process, encompassing both clinical and laboratory-based assessments.
Calibrators
The AxSYM® Anti-CCP Standard Calibrators are for the standard calibration of the AxSYM System when used for the semi-quantitative determination the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma.
Controls
The AxSYM® Anti-CCP Controls are for the use in quality control to monitor the accuracy and precision of the AxSYM Anti-CCP assay when used for the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma on the AxSYM System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063347: Axsym Anti-CCP Reagent, Standard Calibrator and Control Kits, Models 3L91-20, 3L91-01 and 3L91-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063347
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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