# K153145: Lumipulse G TP-N Immunoreaction Cartridge Set

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Jul 5, 2016 after 249 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: 4 generations back to K014233 (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)
- K112343: Treponema Pallidum Treponemal Test Reagents; Quality Control Materials, Siemens Healthcare Diagnostics, Inc. (2012) Summary page 6.

## Indications for use
Lumipulse G TP-N Immunoreaction Cartridges Set For in vitro diagnostic use. WARNING: Lumipulse G TP-N is not intended for blood and tissue donor screening. United States federal law restricts this device to sale by or on the order of a physician. Lumipulse G TP-N is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the qualitative determination of antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma (sodium citrate, or dipotassium EDTA) on the LUMIPULSE G System. Lumipulse G TP-N can 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.

Source page: https://510kreport.com/device/K153145
Methodology: https://510kreport.com/methodology