# K063347: Axsym Anti-CCP Reagent, Standard Calibrator and Control Kits, Models 3L91-20, 3L91-01 and 3L91-10

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: Mar 20, 2007 after 134 days
- Product code: NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp))
- Device class: 2
- Regulation: 21 CFR 866.5775
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K023285 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023285: Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) Elisa, Axis-Shield Diagnostics, Ltd. (2002) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K063347
Methodology: https://510kreport.com/methodology