510(k) · Cleared
ClearedLIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · PRI Procalcitonin Assay
Cleared on Feb 27, 2018 as substantially equivalent to K162827 (bioMerieux, Inc., 2017) and 1 other predicate after an 88-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Feb 27, 2018
- Review
- 88 days
- Class
- Class II
- Product code
- PRI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954418 (1995). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK954418 Intact Parathyroid Hormone (PTH) Immunoassay (Modification)Nichols Institute Diagnostics · 1995
- 3 generations backK020217 Acs:180 and Advia Centaur Ipth ImmunoassayBayer Diagnostics Corp. · 2002 · Recalled
- 2 generations backK132515 Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersDiaSorin, Inc. · 2013
- 1 generation backK141463 Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersDiaSorin, Inc. · 2014
- This deviceK173683 LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN…DiaSorin, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954418 | Intact Parathyroid Hormone (PTH) Immunoassay (Modification) | Nichols Institute Diagnostics | 1995 | — |
| −3 | K020217 | Acs:180 and Advia Centaur Ipth Immunoassay | Bayer Diagnostics Corp. | 2002 | 4 |
| −2 | K132515 | Liaison N-Tact PTH Gen II, Control Set, Calibration Verifiers | DiaSorin, Inc. | 2013 | — |
| −1 | K141463 | Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers | DiaSorin, Inc. | 2014 | — |
| 0 (this device) | K173683 | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS… | DiaSorin, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K162827 | Vidas B.R.a.H.M.S. PCT (PCT)Summary page 5…onin Assay 21 CFR 866.3215(PRI) Product Code: PRI, PMT, NTM, JJX PREDICATE DEVICES VIDAS® B·R·A·H·M·S PCT™ (K162827) DEVICE DESCRIPTION: INTENDED USE: LIAISON® BRAHMS PCT® II GEN assay uses chemiluminescence immunoassay (CLIA) technology for t… | 2017 |
| * | K141463 | Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersSummary page 9…: Calibration Verifiers Similarities and Differences Predicate Device Candidate Device (K141463) - LIAISON® XL ® ® Characteristic LIAISON BRAHMS… | 2014 |
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 23 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 3 of the 11 ancestors have a recall of any class.
- 5 other devices also cite its predicate K162827.
How does its category compare?
All PRI devicesPRI Procalcitonin Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 LIAISON® B.R.A.H.M.S PCT® II GEN assay uses chemiluminescence immunoassay (CLIA) technology for the in vitro quantitative determination of Procalcitonin in human serum and lithium heparin plasma specimens. Used in conjunction with other laboratory findings and clinical assessments, LIAISON® B.R.A.H.M.S PCT® II GEN is intended for use as follows: - to aid in the risk assessment of critically ill patients on their first day of ICU admission for…
Read the full statement (305 words)
The LIAISON® B.R.A.H.M.S PCT® II GEN assay uses chemiluminescence immunoassay (CLIA) technology for the in vitro quantitative determination of Procalcitonin in human serum and lithium heparin plasma specimens. Used in conjunction with other laboratory findings and clinical assessments, LIAISON® B.R.A.H.M.S PCT® II GEN 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.
The LIAISON® Control B.R.A.H.M.S PCT® II GEN (level 1 and level 2) are intended for use as assayed quality control samples to monitor the performance and reliability of the LIAISON® BRAHMS PCT® II GEN assay. The performance characteristics of LIAISON® BRAHMS PCT® II GEN controls have not been established with any other assay or instrument platform different from the LIAISON® Analyzer.
The LIAISON® B.R.A.H.M.S PCT® II GEN Verifiers (four levels) are assayed quality control materials intended in the quantitative verification of calibration and reportable range of the LIAISON® BRAHMS PCT® II GEN assay. The performance characteristics of LIAISON® BRAHMS PCT® II GEN calibration verifiers have not been established in connection with any other assay or instrument platforms different from the LIAISON® Analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173683: LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173683
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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