510(k) · Cleared
ClearedB R A H M S PCT sensitive KRYPTOR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brahms GmbH · PRI Procalcitonin Assay
Cleared on May 31, 2017 as substantially equivalent to DEN150009 (Brahms GmbH, 2016) and 1 other predicate after a 23-day review. Its family tree reaches back 3 generations to 2007. 7 later devices descend from it.
- Decided
- May 31, 2017
- Review
- 23 days
- Class
- Class II
- Product code
- PRI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K071146 (2007). 4 ancestors in all. 7 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK071146 Vidas B.R.a.H.M.S. PCT AssaybioMerieux, Inc. · 2007 · Recalled
- 2 generations backK160911 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2016
- 1 generation backK162827 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2017
- This deviceK171338 B R A H M S PCT sensitive KRYPTORBrahms GmbH · 2017
- Descendant · cites it directly · 1 of its ownK173927 Elecsys BRAHMS PCTRoche Diagnostics · 2018
- Descendant · cites it directly · 0 of its ownK220262 Dimension EXL LOCI BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK192815 Elecsys BRAHMS PCTRoche Diagnostics · 2020
- Descendant · cites it directly · 0 of its ownK200236 VITROS BRAHMS PCT Reagent Pack and CalibratorsOrtho Clinical Diagnostics · 2020
- Descendant · cites it directly · 0 of its ownK181002 Atellica IM BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K173927Elecsys BRAHMS PCTRoche Diagnostics · 2018 · cites it directly1descendant
- K220262Dimension EXL LOCI BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc. · 2022 · cites it directly0descendants
- K192815Elecsys BRAHMS PCTRoche Diagnostics · 2020 · 2 generations on0descendants
- K200236VITROS BRAHMS PCT Reagent Pack and CalibratorsOrtho Clinical Diagnostics · 2020 · cites it directly0descendants
- K181002Atellica IM BRAHMS Procalcitonin (PCT)Siemens Healthcare Diagnostics, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K071146 | Vidas B.R.a.H.M.S. PCT Assay | bioMerieux, Inc. | 2007 | 1 |
| −2 | 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 | — |
| 0 (this device) | K171338 | B R A H M S PCT sensitive KRYPTOR | Brahms GmbH | 2017 | — |
| +1 | K173927 | Elecsys BRAHMS PCT | Roche Diagnostics | 2018 | — |
| +1 | K220262 | Dimension EXL LOCI BRAHMS Procalcitonin (PCT) | Siemens Healthcare Diagnostics, Inc. | 2022 | — |
| +2 | K192815 | Elecsys BRAHMS PCT | Roche Diagnostics | 2020 | — |
| +1 | K200236 | VITROS BRAHMS PCT Reagent Pack and Calibrators | Ortho Clinical Diagnostics | 2020 | — |
| +1 | K181002 | Atellica IM BRAHMS Procalcitonin (PCT) | Siemens Healthcare Diagnostics, Inc. | 2018 | — |
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 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 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
- #2 Held for the reportin the report
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 9…e Information: 1. Predicate device name(s): B·R·A·H·M·S PCT sensitive KRYPTOR® VIDAS B·R·A·H·M·S PCT (PCT) 2. Predicate 510(k) number(s): DEN150009 K162827 Page 19 === Page… | 2016 |
| * | K162827 | Vidas B.R.a.H.M.S. PCT (PCT)Summary page 9…1. Predicate device name(s): B·R·A·H·M·S PCT sensitive KRYPTOR® VIDAS B·R·A·H·M·S PCT (PCT) 2. Predicate 510(k) number(s): DEN150009 K162827 Page 19 B·R·A·H… | 2017 |
What descends from it? (7)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173927 | Elecsys BRAHMS PCT | 2018 | 1 |
| K220262 | Dimension EXL LOCI BRAHMS Procalcitonin (PCT) | 2022 | 0 |
| K200236 | VITROS BRAHMS PCT Reagent Pack and Calibrators | 2020 | 0 |
| K181002 | Atellica IM BRAHMS Procalcitonin (PCT) | 2018 | 0 |
| K172713 | Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT… | 2017 | 0 |
| K170652 | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S… | 2017 | 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 2 companies; a new generation was cleared every 8 months on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K173927 (Roche Diagnostics, 2018) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate DEN150009.
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?
The B·R·A·H·M·S PCT sensitive KRYPTOR® is an immunofluorescent assay using Time-Resolved Amplified Cryptate Emission (TRACE) technology to determine the concentration of PCT (procalcitonin) in human serum and EDTA or heparin plasma. The B·R·A·H·M·S PCT sensitive KRYPTOR® is intended to be performed on the B·R·A·H·M·S KRYPTOR® analyzer family. Used in conjunction with other laboratory findings and clinical assessments, B·R·A·H·M·S PCT sensitive KRYPTOR®…
Read the full statement (201 words)
The B·R·A·H·M·S PCT sensitive KRYPTOR® is an immunofluorescent assay using Time-Resolved Amplified Cryptate Emission (TRACE) technology to determine the concentration of PCT (procalcitonin) in human serum and EDTA or heparin plasma.
The B·R·A·H·M·S PCT sensitive KRYPTOR® is intended to be performed on the B·R·A·H·M·S KRYPTOR® analyzer family.
Used in conjunction with other laboratory findings and clinical assessments, B·R·A·H·M·S PCT sensitive KRYPTOR® 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171338: B R A H M S PCT sensitive KRYPTOR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171338
Report an extraction error
Are you the manufacturer?
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