# K093954: Bioplex 2200 Anti-CCP Kit on the Bioplex 2200 Multi-Analyte Detection System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Aug 24, 2010 after 244 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 K023285 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K112810: Multi-Analyte Detection Systems (2011), 0 descendants of its own

## Recalls of this device
- Feb 21, 2023 · Class II · Z-1378-2023: Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against pr
- Feb 21, 2023 · Class II · Z-1377-2023: Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against pr

## Indications for use
The BioPlex™ 2200 Anti-CCP Kit is a multiplex flow immunoassay intended for the semi-quantitative detection of IgG antibodies to Cyclic Citrullinated Peptide (CCP) in human serum and EDTA or heparinized plasma. Detection of CCP antibodies may be used as an aid in the diagnosis of rheumatoid arthritis and should be used in conjunction with other clinical information. The BioPlex 2200 Anti-CCP kit is intended for use with the Bio-Rad BioPlex 2200 system. The BioPlex™ 2200 Anti-CCP Calibrator Set is intended for the calibration of the BioPlex 2200 Anti-CCP Reagent Pack. The BioPlex™ 2200 Anti-CCP Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and BioPlex 2200 Anti-CCP Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Anti-CCP Control Set has not been established with any other Anti-CCP assay.

Source page: https://510kreport.com/device/K093954
Methodology: https://510kreport.com/methodology