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. · PRI Procalcitonin Assay
Cleared on Feb 23, 2017 as substantially equivalent to K160911 (bioMerieux, Inc., 2016) after a 139-day review. Its family tree reaches back 2 generations to 2007. 21 later devices descend from it.
- Decided
- Feb 23, 2017
- Review
- 139 days
- Class
- Class II
- Product code
- PRI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K071146 (2007). 3 ancestors in all. 21 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK071146 Vidas B.R.a.H.M.S. PCT AssaybioMerieux, Inc. · 2007 · Recalled
- 1 generation backK160911 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2016
- This deviceK162827 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2017
- Descendant · cites it directly · 7 of its ownK171338 B R A H M S PCT sensitive KRYPTORBrahms GmbH · 2017
- Descendant · cites it directly · 3 of its ownK210254 MeMed BVMeMed Diagnostics, Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK220991 IntelliSep testCytovale, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK181599 Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator…Beckman Coulter · 2019
- Descendant · 2 generations on · 1 of its ownK222332 MeMed BVMeMed Diagnostics, Ltd. · 2023
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K171338B R A H M S PCT sensitive KRYPTORBrahms GmbH · 2017 · cites it directly7descendants
- K210254MeMed BVMeMed Diagnostics, Ltd. · 2021 · cites it directly3descendants
- K220991IntelliSep testCytovale, Inc. · 2022 · cites it directly2descendants
- K181599Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator ApplicationBeckman Coulter · 2019 · cites it directly2descendants
- K222332MeMed BVMeMed Diagnostics, Ltd. · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071146 | Vidas B.R.a.H.M.S. PCT Assay | bioMerieux, Inc. | 2007 | 1 |
| −1 | K160911 | Vidas B.R.a.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2016 | — |
| 0 (this device) | K162827 | Vidas B.R.a.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2017 | — |
| +1 | K171338 | B R A H M S PCT sensitive KRYPTOR | Brahms GmbH | 2017 | — |
| +1 | K210254 | MeMed BV | MeMed Diagnostics, Ltd. | 2021 | — |
| +1 | K220991 | IntelliSep test | Cytovale, Inc. | 2022 | — |
| +1 | K181599 | Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application | Beckman Coulter | 2019 | — |
| +2 | K222332 | MeMed BV | MeMed Diagnostics, Ltd. | 2023 | — |
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 | 3 | 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 PRI? 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 PRI device
- #1 K220262 Dimension EXL LOCI BRAHMS Procalcitonin (PCT)score 4.8 · 4 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K160911 | Vidas B.R.a.H.M.S. PCT (PCT)Summary page 4…866.3215, Product Code PMT) Procalcitonin assay (21 CFR 866.3215, Product Code PRI) C. Predicate Devices VIDAS® B·R·A·H·M·S PCTTM (K160911) VIDAS® B·R·A·H·M·S PCTTM… | 2016 |
What descends from it? (21)
See all 216 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171338 | B R A H M S PCT sensitive KRYPTOR | 2017 | 7 |
| K210254 | MeMed BV | 2021 | 3 |
| K220991 | IntelliSep test | 2022 | 2 |
| K181599 | Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application | 2019 | 2 |
| K192271 | Access PCT, Access PCT Calibrators | 2019 | 1 |
| K173683 | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN… | 2018 | 0 |
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?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 8.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K171338 (Brahms GmbH, 2017) has gone furthest, with 7 descendants of its own.
How does its category compare?
All PRI devicesPRI Procalcitonin Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PRI
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · PRI
92in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PRI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PRI
5in 2025
MAUDE reports naming product code PRI, 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 | 0 | — | 0 | 0 |
| 2017 | 4 | 92 | 0 | 0 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 0 | — | 1 | 157 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 5 |
| 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. Used in conjunction with other laboratory findings and clinical assessments, VIDAS® B·R·A·H·M·S PCT™ is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first…
Read the full statement (191 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.
Used in conjunction with other laboratory findings and clinical assessments, VIDAS® B·R·A·H·M·S PCT™ is intended for use as follows:
• 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,
• to aid in assessing the cumulative 28-day risk of all-cause mortality 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, using a change in PCT level over time,
• to aid in decision making on antibiotic therapy for patients with suspected or confirmed lower respiratory tract infections (LRTI) – defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD) – in an inpatient setting or an emergency department,
• to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.
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/K162827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162827: 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 6, 2026. https://510kreport.com/device/K162827
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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