510(k) · Cleared
Recalled · Class II · 2022Vidas B.R.a.H.M.S. PCT Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · NTM Antigen, Inflammatory Response Marker, Sepsis
Cleared on Oct 11, 2007 after a 170-day review. The FDA summary names its predicate without a number. 24 later devices descend from it. It has been recalled once.
- Decided
- Oct 11, 2007
- Review
- 170 days
- Class
- Class II
- Product code
- NTM
- Recalls
- 1
- Predicates
- 0
24 later devices descend from it, 2 citing it directly.
- This deviceK071146 Vidas B.R.a.H.M.S. PCT AssaybioMerieux, Inc. · 2007
- Descendant · cites it directly · 22 of its ownK160911 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2016
- Descendant · 2 generations on · 21 of its ownK162827 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2017
- Descendant · 3 generations on · 7 of its ownK171338 B R A H M S PCT sensitive KRYPTORBrahms GmbH · 2017
- Descendant · 3 generations on · 3 of its ownK210254 MeMed BVMeMed Diagnostics, Ltd. · 2021
- Descendant · 3 generations on · 2 of its ownK220991 IntelliSep testCytovale, Inc. · 2022
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K160911Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2016 · cites it directly22descendants
- K162827Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2017 · 2 generations on21descendants
- K171338B R A H M S PCT sensitive KRYPTORBrahms GmbH · 2017 · 3 generations on7descendants
- K210254MeMed BVMeMed Diagnostics, Ltd. · 2021 · 3 generations on3descendants
- K220991IntelliSep testCytovale, Inc. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071146 | Vidas B.R.a.H.M.S. PCT Assay | bioMerieux, Inc. | 2007 | — |
| +1 | K160911 | Vidas B.R.a.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2016 | — |
| +2 | K162827 | Vidas B.R.a.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2017 | — |
| +3 | K171338 | B R A H M S PCT sensitive KRYPTOR | Brahms GmbH | 2017 | — |
| +3 | K210254 | MeMed BV | MeMed Diagnostics, Ltd. | 2021 | — |
| +3 | K220991 | IntelliSep test | Cytovale, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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 | 3 | 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 NTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | BRAHMS PCT LIA Assay Named without a submission number |
What descends from it? (24)
See all 242 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2022 | Class II | Z-0868-2023 | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K160911 (bioMerieux, Inc., 2016) has gone furthest, with 22 descendants of its own.
How does its category compare?
All NTM devicesNTM Antigen, Inflammatory Response Marker, Sepsis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NTM
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · NTM
Too few NTM 510(k)s in any year since 2007 to give a median.
Recalls per year · NTM
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NTM
2in 2024
MAUDE reports naming product code NTM, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 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 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VIDASC BRAHMS PCT is an automated test for use on the VIDAS instruments for the determination of human procalcitonin in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. The VIDAS BRAHMS PCT assay 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071146 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071146: Vidas B.R.a.H.M.S. PCT Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071146
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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