# K103834: Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control Sets

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Mar 30, 2012 after 456 days
- Product code: MID (System, Test, Anticardiolipin Immunological)
- 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 K013080 (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)
- K022992: Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001, Corgenix, Inc. (2002) Summary page 2.
- K022990: Reaads Iga Anti-Cardiolipin Semi-Quantitative Test Kit, Model 026-001, Corgenix, Inc. (2002) Summary page 2.
- K013080: Reaads Anti-Beta 2 Glycoprotein I Igg Test Kit, Corgenix, Inc. (2001) Summary page 7.
- K013079: Reaads Anti-Beta 2 Glycoprotein I Iga Test Kit, Corgenix, Inc. (2001) Summary page 6.

## Indications for use
The BioPlex® 2200 APLS IgG and IgA kits are multiplex flow immunoassays intended for the semi-quantitative detection of IgG and IgA antibodies to Cardiolipin (CL) and Beta-2 Glycoprotein I (β2GP1) in human serum and plasma (lithium heparin, sodium heparin, and sodium citrate). In conjunction with other clinical findings, the test systems are used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders. The BioPlex 2200 APLS IgG and IgA kits are intended for use with the Bio-Rad BioPlex 2200 System The BioPlex® 2200 APLS IgG and IgA Calibrator Sets are intended for the calibration of the corresponding BioPlex 2200 APLS IgG and IgA Reagent Packs. The BioPlex® 2200 APLS IgG and IgA Control Sets are intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and the corresponding BioPlex 2200 APLS IgG and IgA Reagent Packs in the clinical laboratory. The performance of the BioPlex 2200 APLS IgG and IgA Control Sets has not been established with any other anti-Cardiolipin and anti-Beta-2 Glycoprotein I IgG or IgA APS assays.

Source page: https://510kreport.com/device/K103834
Methodology: https://510kreport.com/methodology