# K130053: Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga and Igg Calibrator Sets, and BI

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Sep 19, 2013 after 247 days
- Product code: MVM (Autoantibodies, Endomysial(Tissue Transglutaminase))
- Device class: 2
- Regulation: 21 CFR 866.5660
- 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 K011566 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011566: Quanta Lite H-TTG (Human Tissue Transglutaminase) Iga Elisa, Inova Diagnostics, Inc. (2001)
- K011570: Quanta Lite H-TTG (Human Tissue Transglutaminase) Igg Elisa, Inova Diagnostics, Inc. (2001) Summary page 4.
- K052143: Quanta Lite Gliadin Iga II, Inova Diagnostics, Inc. (2005) Summary page 4.
- K052142: Quanta Lite Gliadin Igg II, Inova Diagnostics, Inc. (2005) Summary page 4.

## Indications for use
The BioPlex 2200 Celiac IgA kit is an in vitro multiplex flow immnunoassay intended for the semi-quantitative detection of IgA autoantibodies to deamidlated gliadin peptide (DO?) and tissue Transglutaminase (tl'G) in human serum. In conjunction with clinical. findings and other diagnostic tests, the test system is used as an aid in the diagnosis of Celiac Disease (gluten-sensitive enteropathy). The lBioPlex 2200 Celiac IgA kit is intended for use with the Bio-Rad BioPlex 2200 System. The SioPlex 2200 Celiac IgA Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and the BioPlex 2200 Celiac IgA Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Celiac IgA Control Set has not been established with any other anti-tissue Transglutaminase (tTG) and anti-deamidated gliadin peptide IgA assays. The BioPlex 2200 Celiac IgA Calibrator Set is intended for the calibration of the BioPlex 2200 Celiac IgA Reagent Pack. Tlhe BioPlex 2200 Celiac IgO Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and the SioPlex 2200 Celiac IgG Reagent Pack in the clinical laboratory. The performance of the lBioPlex 2200 Celiac IgO Control Set has not been established with any other anti-tissue Transglutaminase (tTG) and anti-deamidated gliadin peptide IgO assays. The lBioPlex 2200 Celiac igG Calibrator Set is intended for the calibration of the BioPlex 2200 Celiac Igo Reagent Pack. The BioPlex 2200 Celiac lgG kit is an in vitro multiplex flow immunoassay intended for the semi-quantitative detection of IgG aiitoantibhodies to deaniidated gliadin peptide (DGP) and tissue Transglutaminase (tTG) in human serum. In conjunction with clinical findings and other diagnostic tests, the test system is used as an aid in the diagnosis of Celiac Disease (gluten-sensitive enteropathy). The Biorlex 2200 Celiac lgG kit is intended for use with the Bio-Rad BioPlex 2200 System.

Source page: https://510kreport.com/device/K130053
Methodology: https://510kreport.com/methodology