# K063866: Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Mar 19, 2007 after 80 days
- Product code: LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum)
- Device class: 2
- Regulation: 21 CFR 866.3830
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971502 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971502: Serodia TP-PA, Scimedx Tekfile Services (1997) Summary page 2.
- K001552: Trepchek Treponemal Antibody Eia, Phoenix Biotech Corp. (2000) Summary page 2.
- (no number) Macro-Vue RPR Card (Becton Dickenson): named in the summary without a submission number

## Most influential descendants
- K120439: Bioplex 2200 Ebv Igg and Syphilis Igg (2012), 0 descendants of its own

## Recalls of this device
- Nov 23, 2010 · Not classified · Z-1650-2011: An upward shift in the control values can result in a control value that falls outside of the current manufacturing ranges.
- Nov 13, 2007 · Not classified · Z-1156-2008: False negative results due to reagent packs exhibiting low signal.
- Sep 25, 2007 · Not classified · Z-0256-2008: Mislabeling: Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed Instructions for Use. (Non-Reactive and Reactive rather than Negative and Positive)

## Indications for use
The Bio-Rad Syphilis IgG kit is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidum IgG antibodies in human serum. The test system, when used in conjunction with non-treponemal based assays, provides serological evidence of infection with T. pallidum. This test system is also indicated for use in confirming reactive test results from non-treponemal based screening assays. The Syphilis IgG kit is intended for use with the Bio-Rad BioPlex 2200 System. The BioPlex 2200 Syphilis IgG kit is not intended for use in screening blood or plasma donors. Warning: A positive result is not useful for establishing a diagnosis of Syphilis. In most situations, such a result may reflect prior treated infection; a negative result can exclude a diagnosis of syphilis except for incubating or early primary disease.

Source page: https://510kreport.com/device/K063866
Methodology: https://510kreport.com/methodology