510(k) · Cleared
ClearedARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher Diagnostics · PRI Procalcitonin Assay
Cleared on Jun 1, 2017 as substantially equivalent to K171338 (Brahms GmbH, 2017) after a 90-day review. Its family tree reaches back 4 generations to 2007.
- Decided
- Jun 1, 2017
- Review
- 90 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 deviceK170652 ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators…Fisher Diagnostics · 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) | K170652 | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT… | Fisher Diagnostics | 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 KRYPTOR Cleared while this submission was under review Summary page 8…tte tips K. SUBSTANTIAL EQUIVALENCE INFORMATION 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: ARCHITECT B.R.A.H.M.S PCT B.R.A.H.M.S PCT sensiti… | 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?
The ARCHITECT B∙R∙A∙H∙M∙S PCT assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of procalcitonin (PCT) in human serum and plasma (lithium heparin and K2EDTA) on the ARCHITECT iSystem. Used in conjunction with other laboratory findings and clinical assessments, the ARCHITECT B∙R∙A∙H∙M∙S PCT assay is intended for use as an: • Aid in the risk assessment of critically ill patients on their first day of intensive…
Read the full statement (270 words)
The ARCHITECT B∙R∙A∙H∙M∙S PCT assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of procalcitonin (PCT) in human serum and plasma (lithium heparin and K2EDTA) on the ARCHITECT iSystem.
Used in conjunction with other laboratory findings and clinical assessments, the ARCHITECT B∙R∙A∙H∙M∙S PCT assay 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.
The ARCHITECT B∙R∙A∙H∙M∙S PCT Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of procalcitonin (PCT) in human serum and plasma (lithium heparin and K2EDTA). For in vitro diagnostic use only.
The ARCHITECT B∙R∙A∙H∙M∙S PCT Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem when used for the quantitative determination of procalcitonin (PCT) in human serum and plasma (lithium heparin and K2EDTA). For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170652 · printed Nov 6, 2026
Cite this page
510(k) Report. “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 PCT Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170652
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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