# K130528: Bioplex 2200 Apls Igm

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Oct 21, 2013 after 234 days
- Product code: MID (System, Test, Anticardiolipin Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K022992 (2002). 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)
- K092181: Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm Controls, Instrumentation Laboratory CO (2010) Summary page 4.
- K091556: Hemosil Acustar Anti-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm Controls, Instrumentation Laboratory CO (2010)

## Recalls of this device
- Feb 28, 2023 · Class II · Z-1572-2023: APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.

## Indications for use
The BioPlex®i, 2200 Antiphospholipid Syndrome (AILS) IgM kit'is a multiplex flow immunoassay intended for the semi-quantitative detection of IgM antibodies to Cardiolipin (CI.) and Beta-2 Glycoprotein I (132G1'I) in human serum and plasma (lithium heparin, sodium heparin, and sodium citrate). In conjunction with other clinical findings, the test system is used as an aid in the diagnosis of primary Antiphospholipid Syndrome (Al'S) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders. The B3iolex 2200 AILS IgMt kit is intended For use with the Bio-Rad BioPlex 2200 System The IlioPlex 2200 Antiphospholipid Syndrome (APLS) IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and the corresponding liiol'Iex 2200 API.S IgM4 Reagent Pack in the clinical laboratory. The performance of the BioI'ex 2200 APILS IgM Control Set has not been established with any other Antiphospholipid assay. The lBiollex 2200 AILS IgM Calibrator Set is intended for the calibration of the corresponding BioPlex 2200 APLS IgM Reagent Pack.

Source page: https://510kreport.com/device/K130528
Methodology: https://510kreport.com/methodology