510(k) · Cleared
ClearedVidas B.R.a.H.M.S. PCT (PCT)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
Cleared on Jun 28, 2016 as substantially equivalent to DEN150009 (Brahms GmbH, 2016) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 2007. 22 later devices descend from it.
- Decided
- Jun 28, 2016
- Review
- 88 days
- Class
- Class II
- Product code
- PMT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K071146 (2007). 2 ancestors in all. 22 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK071146 Vidas B.R.a.H.M.S. PCT AssaybioMerieux, Inc. · 2007 · Recalled
- This deviceK160911 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2016
- Descendant · cites it directly · 21 of its ownK162827 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2017
- Descendant · 2 generations on · 7 of its ownK171338 B R A H M S PCT sensitive KRYPTORBrahms GmbH · 2017
- Descendant · 2 generations on · 3 of its ownK210254 MeMed BVMeMed Diagnostics, Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK220991 IntelliSep testCytovale, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK181599 Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator…Beckman Coulter · 2019
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K162827Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2017 · cites it directly21descendants
- K171338B R A H M S PCT sensitive KRYPTORBrahms GmbH · 2017 · 2 generations on7descendants
- K210254MeMed BVMeMed Diagnostics, Ltd. · 2021 · 2 generations on3descendants
- K220991IntelliSep testCytovale, Inc. · 2022 · 2 generations on2descendants
- K181599Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator ApplicationBeckman Coulter · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071146 | Vidas B.R.a.H.M.S. PCT Assay | bioMerieux, Inc. | 2007 | 1 |
| 0 (this device) | K160911 | Vidas B.R.a.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2016 | — |
| +1 | K162827 | Vidas B.R.a.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2017 | — |
| +2 | K171338 | B R A H M S PCT sensitive KRYPTOR | Brahms GmbH | 2017 | — |
| +2 | K210254 | MeMed BV | MeMed Diagnostics, Ltd. | 2021 | — |
| +2 | K220991 | IntelliSep test | Cytovale, Inc. | 2022 | — |
| +2 | K181599 | Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application | Beckman Coulter | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (2)
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 4…PMT) – Class II in vitro Diagnostic device C. Predicate Devices Predicate device 1, trade name: B·R·A·H·M·S PCT Sensitive KRYPTOR® (DEN150009) Predicate device 2, trade name: VIDAS® B·R·A·H·M·S PCTTM (K071146)… | 2016 |
| * | K071146 | Vidas B.R.a.H.M.S. PCT AssaySummary page 4…device C. Predicate Devices Predicate device 1, trade name: B·R·A·H·M·S PCT Sensitive KRYPTOR® (DEN150009) Predicate device 2, trade name: VIDAS® B·R·A·H·M·S PCTTM (K071146) Page 1… | 2007 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162827 | Vidas B.R.a.H.M.S. PCT (PCT) | 2017 | 21 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
VIDAS® B·R·A·H·M·S PCT™ (PCT) is an automated test for use on the instruments of the VIDAS® family for the determination of human procalcitonin in human serum or plasma (lithium heparinate) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. VIDAS® B·R·A·H·M·S PCT™ (PCT) is intended for use in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment of critically ill patients on their first day of ICU…
Read the full statement (373 words)
VIDAS® B·R·A·H·M·S PCT™ (PCT) is an automated test for use on the instruments of the VIDAS® family for the determination of human procalcitonin in human serum or plasma (lithium heparinate) using the ELFA (Enzyme-Linked Fluorescent Assay) technique.
VIDAS® B·R·A·H·M·S PCT™ (PCT) is intended for use in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock.
VIDAS® B·R·A·H·M·S PCT™ (PCT) is also intended for use to determine the change of PCT level over time as an aid in assessing the cumulative 28-day risk of all-cause mortality in conjunction with other laboratory findings 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 levels on the first day of ICU admission above 2.0 ng/mL are associated with a higher risk for progression to severe sepsis and/or septic shock than PCT levels below 0.5 ng/mL.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160911 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160911: Vidas B.R.a.H.M.S. PCT (PCT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160911
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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