510(k) · Cleared
ClearedElecsys BRAHMS PCT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · PRI Procalcitonin Assay
Cleared on Mar 9, 2020 as substantially equivalent to K173927 (Roche Diagnostics, 2018) after a 160-day review. Its family tree reaches back 5 generations to 2007.
- Decided
- Mar 9, 2020
- Review
- 160 days
- Class
- Class II
- Product code
- PRI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K071146 (2007). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK071146 Vidas B.R.a.H.M.S. PCT AssaybioMerieux, Inc. · 2007 · Recalled
- 4 generations backK160911 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2016
- 3 generations backK162827 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2017
- 2 generations backK171338 B R A H M S PCT sensitive KRYPTORBrahms GmbH · 2017
- 1 generation backK173927 Elecsys BRAHMS PCTRoche Diagnostics · 2018
- This deviceK192815 Elecsys BRAHMS PCTRoche Diagnostics · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K071146 | Vidas B.R.a.H.M.S. PCT Assay | bioMerieux, Inc. | 2007 | 1 |
| −4 | K160911 | Vidas B.R.a.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2016 | — |
| −3 | 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 | — |
| −1 | K173927 | Elecsys BRAHMS PCT | Roche Diagnostics | 2018 | — |
| 0 (this device) | K192815 | Elecsys BRAHMS PCT | Roche Diagnostics | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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
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 |
|---|---|---|---|
| * | K173927 | Elecsys BRAHMS PCTSummary page 5…spected sepsis Product Codes, PRI, PMT, NTM, 866.3215 Regulation Numbers Predicate Devices Elecsys BRAHMS PCT cleared under K173927. For the Elecsys BRAHMS PCT Test System the establishment registration… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All PRI devicesPRI Procalcitonin Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys 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…
Read the full statement (188 words)
Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin).
The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.
Used in conjunction with other laboratory findings and clinical assessments, Elecsys 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 determine the change in PCT level 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 ICU or when obtained in the emergency department or other medical wards prior to ICU admission,
• to aid in decision making on antibiotic therapy, for inpatients or patients in the emergency department 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),
• to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192815: Elecsys BRAHMS PCT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192815
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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