# K023285: Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: Oct 9, 2002 after 23 days
- Product code: NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp))
- Device class: 2
- Regulation: 21 CFR 866.5775
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 5 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K093954: Bioplex 2200 Anti-CCP Kit on the Bioplex 2200 Multi-Analyte Detection System (2010), 1 descendant of its own
- K061165: Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01 (2006), 1 descendant of its own
- K151799: EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 (2016), 0 descendants of its own
- K121576: Immulite 2000 Anti-CCP Igg Assay (2013), 0 descendants of its own
- K112810: Multi-Analyte Detection Systems (2011), 0 descendants of its own

## Recalls of this device
- Nov 11, 2005 · Not classified · Z-0003-2007: 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%.

## Indications for use
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.

Source page: https://510kreport.com/device/K023285
Methodology: https://510kreport.com/methodology