# K153730: ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 15, 2016 after 170 days
- Product code: LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum)
- Device class: 2
- Regulation: 21 CFR 866.3830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K014233 (2002). 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)
- K061247: Diasorin Liaison Treponema Assay, DiaSorin, Inc. (2006) Summary page 5.

## Most influential descendants
- K241427: Access Syphilis (2024), 0 descendants of its own

## Indications for use
The ARCHITECT Syphilis TP assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of antibodies (IgG and IgM) directed against Treponema pallidum (TP) in human serum and plasma. The ARCHITECT Syphilis TP assay is intended to be used as an initial diagnostic test or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection. Warning: The ARCHITECT Syphilis TP assay is not intended for use in screening blood, plasma, or tissue donors. The effectiveness of the ARCHITECT Syphilis TP assay for use in screening blood, plasma, or tissue donors has not been established. The ARCHITECT Syphilis TP Calibrator is for the calibration of the ARCHITECT iSystem when used for the qualitative detection of antibody to Treponema pallidum (TP) in human serum and plasma. The ARCHITECT Syphilis TP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem when used for the qualitative detection of antibody to Treponema pallidum (TP) in human serum and plasma.

Source page: https://510kreport.com/device/K153730
Methodology: https://510kreport.com/methodology