# DEN150009: B.R.A.H.M.S PCT sensitive KRYPTOR

- Pathway: De Novo (Direct)
- Applicant: Brahms GmbH
- Decided: Feb 20, 2016 after 353 days
- Product code: PMT (Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens)
- 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
No predicates in its family tree.
27 later devices descend from it; 5 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K160911: Vidas B.R.a.H.M.S. PCT (PCT) (2016), 22 descendants of its own
- K162827: Vidas B.R.a.H.M.S. PCT (PCT) (2017), 21 descendants of its own
- K171338: B R A H M S PCT sensitive KRYPTOR (2017), 7 descendants of its own
- K210254: MeMed BV (2021), 3 descendants of its own
- K220991: IntelliSep test (2022), 2 descendants of its own

## Indications for use
The B· R· A· H· M· S PCT sensitive KRYPTOR is an immunofluorescent assay using Time-Resolved Amplified Cryptate Emission (TRACE) technology to determine the concentration of PCT (procalcitonin) in human serum and EDTA or heparin plasma. The B· R· A· H· M· S PCT sensitive KRYPTOR is intended to be performed on the B· R· A· H· M· S KRYPTOR analyzer family. The B· R A- H· M· S PCT sensitive KRYPTOR is intended for use in conjunction with other laboratory fmdings and clinical assessments to 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. The B· R· A- H- M· S PCT sensitive KRYPTOR is also intended for use to determine the change in PCT level over time as an aid in assessing the cumulative 28-day risk of all-cause mortality in conjunction with other laboratory fmdings and clinical assessments 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. Procalcitonin (PCT) is a biomarker associated with the inflammatory response to bacterial infection that aids 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. The percent change in PCT level over time also aids in the prediction of cumulative 28-day mortality in patients with severe sepsis and septic shock. PCT level on the first day of ICU admission above 2.0 Jlg/L is associated with a higher risk for progression to severe sepsis and/or septic shock than a PCT level below 0.5 Jlg/L. A PCT level that declines::; 80% from the day that severe sepsis or septic shock was clinically diagnosed (Day 0) to four days after clinical diagnosis (Day 4) is associated with higher cumulative 28-day risk of all-cause mortality than a decline > 80%. The combination of the PCT level (:'0 2.0 ug!L or> 2.0 Jlg/L) at initial diagnosis of severe sepsis or septic shock with the patient's clinical course and the change in PCT level over time until Day 4 provides important additional information about the mortality risk. The PCT level on Day I (the day after severe sepsis or septic shock is first clinically diagnosed) can be used to calculate the percent change in PCT level at Day 4 if the Day 0 measurement is unavailable.

Source page: https://510kreport.com/device/DEN150009
Methodology: https://510kreport.com/methodology