510(k) · Cleared
Recalled · Class II · 2017Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
Cleared on Jun 13, 2016 as substantially equivalent to DEN150009 (Brahms GmbH, 2016) and 2 other predicates after an 89-day review. Its family tree reaches back 4 generations to 2010. It has been recalled once.
- Decided
- Jun 13, 2016
- Review
- 89 days
- Class
- Class II
- Product code
- PMT
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 4 generations to K093582 (2010). 7 ancestors in all, the oldest K964841 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backK093582 Elecsys CK-MB Calcheck 5Roche Diagnostics · 2010
- 3 generations backK133284 Elecsys CK-MB Calcheck 5Roche Diagnostics · 2013
- 2 generations backK142127 Elecsys Estradiol Iii Calcheck 5Roche Diagnostics · 2014
- 1 generation backK150955 Elecsys Progesterone III Cal Check 5Roche Diagnostics · 2015
- This deviceK160729 Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5Roche Diagnostics · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K093582 | Elecsys CK-MB Calcheck 5 | Roche Diagnostics | 2010 | — |
| −3 | K133284 | Elecsys CK-MB Calcheck 5 | Roche Diagnostics | 2013 | — |
| −2 | K142127 | Elecsys Estradiol Iii Calcheck 5 | Roche Diagnostics | 2014 | — |
| −1 | K150955 | Elecsys Progesterone III Cal Check 5 | Roche Diagnostics | 2015 | — |
| 0 (this device) | K160729 | Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 | Roche Diagnostics | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PMT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PMT device
- #1 K200236 VITROS BRAHMS PCT Reagent Pack and Calibratorsscore -0.2 · 4 generations · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN150009 | B.R.A.H.M.S PCT sensitive KRYPTORSummary page 9…Candidate Device: Elecsys Predicate Device: BRAHMS PCT sensitive Feature BRAHMS PCT (K160729) KRYPTOR®(DEN150009) Intended Use/ Immunoassay for the in vitro quantitative determination of PCT Indications for Use (proc… | 2016 |
| * | K152526 | Elecsys Progesterone III CalSetSummary page 14…Candidate Device: PCT CalSet CalSet Predicate Device: (K160729) Progesterone III CalSet (K152526) Intended Use PCT CalSet is used for calibrating The Progesterone III CalSet is used… | 2015 |
| * | K150955 | Elecsys Progesterone III Cal Check 5Summary page 16…csys CalCheck 5 (K160729) Progesterone III CalCheck 5 (K150955) Intended Use The BRAHMS PCT CalCheck 5 is The Elecsys Progesterone III an as… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2017 | Class II | Z-1311-2018 | Software design | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- None of the 7 ancestors has a recall.
- 4 other devices also cite its predicate DEN150009.
How does its category compare?
All PMT devicesPMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PMT
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PMT
Too few PMT 510(k)s in any year since 2007 to give a median.
Recalls per year · PMT
No recall names PMT since 2007.
Adverse event reports per year · PMT
1in 2025
MAUDE reports naming product code PMT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 3 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (329 words)
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,
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160729 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160729: Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160729
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026