# K172713: Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Dec 10, 2017 after 93 days
- Product code: PRI (Procalcitonin Assay)
- Device class: 2
- Regulation: 21 CFR 866.3215
- 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 K071146 (2007). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171338: B R A H M S PCT sensitive KRYPTOR, Brahms GmbH (2017) Summary page 6.

## Indications for use
Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges: The Lumipulse G B•R•A•H•M•S PCT is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of PCT (procalcitonin) in human serum and plasma (sodium heparin, lithium heparin, sodium citrate or dipotassium EDTA) on the LUMIPULSE G System. Used in conjunction with other laboratory findings and clinical assessments, Lumipulse G B•R•A•H•M•S PCT is intended for use as an: • Aid in the risk assessment of critically ill patients on their first day of intensive care unit (ICU) admission for progression to severe sepsis and septic shock. • Aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, using a change in PCT level over time. • Aid in decision making on antibiotic therapy for patients with suspected or confirmed lower respiratory tract infections (LRTI) – defined as community acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD) – in an inpatient setting or an emergency department. • Aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis. Lumipulse G B∙R∙A∙H∙M∙S PCT Calibrators set Lumipulse G B∙R∙A∙H∙M∙S PCT Calibrators set is for in vitro diagnostic use in the calibration of Lumipulse G B∙R∙A∙H∙M∙S PCT on the LUMIPULSE G System.

Source page: https://510kreport.com/device/K172713
Methodology: https://510kreport.com/methodology