510(k) · Cleared
ClearedVITROS BRAHMS PCT Reagent Pack and Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Clinical Diagnostics · PMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
Cleared on Feb 25, 2020 as substantially equivalent to K171338 (Brahms GmbH, 2017) after a 26-day review. Its family tree reaches back 4 generations to 2007.
- Decided
- Feb 25, 2020
- Review
- 26 days
- Class
- Class II
- Product code
- PMT
- 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 deviceK200236 VITROS BRAHMS PCT Reagent Pack and CalibratorsOrtho Clinical Diagnostics · 2020
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) | K200236 | VITROS BRAHMS PCT Reagent Pack and Calibrators | Ortho Clinical 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 PMT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 7…gh Sample Diluent B • Quality Controls materials J. Substantial Equivalence Information: 1. Predicate device name: B∙R∙A∙H∙M∙S PCT Sensitive KRYPTOR, K171338 2. Comparison with predicate: Device New Device Predicate Device… | 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 13 years and passes through 3 companies; a new generation was cleared every 2.7 years 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 PMT devicesPMT Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PMT
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PMT
Too few PMT 510(k)s in any year since 2007 to give a median.
Recalls per year · PMT
No recall names PMT since 2007.
Adverse event reports per year · PMT
1in 2025
MAUDE reports naming product code PMT, 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 | 3 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in-vitro diagnostic use only. For the quantitative measurement of procalcitonin (PCT) in human serum and plasma (lithium heparin and EDTA) using the VITROS 3600 Immunodiagnostic System. Used in conjunction with other laboratory findings and clinical assessments, the VITROS B•R•A•H•M•S PCT test 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…
Read the full statement (182 words)
For in-vitro diagnostic use only.
For the quantitative measurement of procalcitonin (PCT) in human serum and plasma (lithium heparin and EDTA) using the VITROS 3600 Immunodiagnostic System.
Used in conjunction with other laboratory findings and clinical assessments, the VITROS B•R•A•H•M•S PCT test 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200236: VITROS BRAHMS PCT Reagent Pack and Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200236
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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