# K160729: Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jun 13, 2016 after 89 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K093582 (2010). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150009: B.R.A.H.M.S PCT sensitive KRYPTOR, Brahms GmbH (2016) Summary page 9.
- K152526: Elecsys Progesterone III CalSet, Roche Diagnostics (2015) Summary page 14.
- K150955: Elecsys Progesterone III Cal Check 5, Roche Diagnostics (2015) Summary page 16.

## Recalls of this device
- Dec 22, 2017 · Class II · Z-1311-2018: Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.

## Indications for use
Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin). The Elecsys BRAHMS PCT assay is intended for use to determine the change of PCT over time as an aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the Intensive Care Unit (ICU) or when obtained in the emergency department or other medical wards prior to ICU admission. The electrochemiluminescence immunoassay “ECLIA”™ is intended for use on Elecsys and cobas e immunoassay analyzers. 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 aids in the prediction of cumulative 28-day mortality in patients with severe sepsis and septic shock. 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 first PCT level (< 2.0 ng/mL or > 2.0 ng/mL) 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 1 (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. The Elecsys BRAHMS PCT Calcheck 5 is an assayed control for use in calibration verification and for use in verification of the assay range established for the Elecsys BRAHMS PCT assay on the Elecsys and cobas e analyzers,

Source page: https://510kreport.com/device/K160729
Methodology: https://510kreport.com/methodology