510(k) · Cleared
ClearedLumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · PRI Procalcitonin Assay
Cleared on Dec 10, 2017 as substantially equivalent to K171338 (Brahms GmbH, 2017) after a 93-day review. Its family tree reaches back 4 generations to 2007.
- Decided
- Dec 10, 2017
- Review
- 93 days
- Class
- Class II
- Product code
- PRI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K071146 (2007). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK071146 Vidas B.R.a.H.M.S. PCT AssaybioMerieux, Inc. · 2007 · Recalled
- 3 generations backK160911 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2016
- 2 generations backK162827 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2017
- 1 generation backK171338 B R A H M S PCT sensitive KRYPTORBrahms GmbH · 2017
- This deviceK172713 Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G…Fujirebio Diagnostics,Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K071146 | Vidas B.R.a.H.M.S. PCT Assay | bioMerieux, Inc. | 2007 | 1 |
| −3 | 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 | — |
| −1 | K171338 | B R A H M S PCT sensitive KRYPTOR | Brahms GmbH | 2017 | — |
| 0 (this device) | K172713 | Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S… | Fujirebio Diagnostics,Inc. | 2017 | — |
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
- #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 |
|---|---|---|---|
| * | K171338 | B R A H M S PCT sensitive KRYPTORSummary page 6…ed calibrator. J. Substantial Equivalence: 1. Predicate device name(s): B•R•A•H•M•S PCT sensitive KRYPTOR® 2. Predicate 510(k) number(s): k171338 3. Comparison with predicate: Comparison between the Lumipulse® G B•R•A•H•M•S PCT and… | 2017 |
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 10 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 1 of the 5 ancestors has a recall of any class.
- 5 other devices also cite its predicate K171338.
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?
Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges: The Lumipulse G B•R•A•H•M•S PCT is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of PCT (procalcitonin) in human serum and plasma (sodium heparin, lithium heparin, sodium citrate or dipotassium EDTA) on the LUMIPULSE G System. Used in conjunction with other laboratory findings and clinical assessments, Lumipulse G B•R•A•H•M•S PCT is intended for use as an: • Aid in…
Read the full statement (229 words)
Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges:
The Lumipulse G B•R•A•H•M•S PCT is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of PCT (procalcitonin) in human serum and plasma (sodium heparin, lithium heparin, sodium citrate or dipotassium EDTA) on the LUMIPULSE G System.
Used in conjunction with other laboratory findings and clinical assessments, Lumipulse G B•R•A•H•M•S PCT is intended for use as an:
• Aid 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.
• 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.
• 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.
• Aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.
Lumipulse G B∙R∙A∙H∙M∙S PCT Calibrators set
Lumipulse G B∙R∙A∙H∙M∙S PCT Calibrators set is for in vitro diagnostic use in the calibration of Lumipulse G B∙R∙A∙H∙M∙S PCT on the LUMIPULSE G System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172713: Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172713
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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