# K081338: Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol Anti-CCP

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Sep 11, 2008 after 121 days
- Product code: NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp))
- Device class: 2
- Regulation: 21 CFR 866.5775
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K052133 (2005). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052133: Immunoscan RA Anti-CCP Test System, Eurodiagnostica (2005) Summary page 2.

## Most influential descendants
- K121895: Elecsys HSV-2 Igg Immunoassay (2012), 1 descendant of its own
- K120625: Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSV (2012), 1 descendant of its own
- K220923: Elecsys HSV-1 IgG (08948844160) (2022), 0 descendants of its own
- K220924: Elecsys HSV-2 IgG (08948887160) (2022), 0 descendants of its own

## Recalls of this device
- Jul 16, 2019 · Class II · Z-2362-2019: Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.
- Jul 16, 2019 · Class II · Z-2361-2019: Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.

## Indications for use
Immunoassay for the in vitro semi-quantitative determination of human IgG autoantibodies to cyclic citrullinated peptides in human serum and plasma. The results of the assay are intended to be used as an aid in the diagnosis of rheumatoid arthritis in combination with other clinical and laboratory findings. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. Elecsys PreciControl Anti-CCP is used for quality control of the Elecsys Anti-CCP immunoassay on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K081338
Methodology: https://510kreport.com/methodology