510(k) · Cleared
ClearedDiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diasys Diagnostic Systems GmbH · PTF Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
Cleared on May 9, 2025 as substantially equivalent to K071146 (bioMerieux, Inc., 2007) after a 280-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- May 9, 2025
- Review
- 280 days
- Class
- Class II
- Product code
- PTF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071146 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK071146 Vidas B.R.a.H.M.S. PCT AssaybioMerieux, Inc. · 2007 · Recalled
- This deviceK242294 DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set…Diasys Diagnostic Systems GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K071146 | Vidas B.R.a.H.M.S. PCT Assay | bioMerieux, Inc. | 2007 | 1 |
| 0 (this device) | K242294 | DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys… | Diasys Diagnostic Systems GmbH | 2025 | — |
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 PTF? 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 PTF device
- #1 K222996 Access PCTscore 6.1 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K071146 | Vidas B.R.a.H.M.S. PCT AssaySummary page 5…) Predicate Device(s): Substantial Equivalence to: K Number Model Manufacturer K071146 VIDAS B.R.A.H.M.S. PCT ASSAY bioMérieux, Inc. Reference Device(s): K Number… | 2007 |
| † | K162297 | Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme… | 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?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K071146.
How does its category compare?
All PTF devicesPTF Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PTF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PTF
Too few PTF 510(k)s in any year since 2007 to give a median.
Recalls per year · PTF
No recall names PTF since 2007.
Adverse event reports per year · PTF
No MAUDE report names PTF since 2007.
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 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DiaSys Procalcitonin FS assay is a particle enhanced immunoturbidimetric test intended for the quantitative in vitro determination of procalcitonin (PCT) in human serum and lithium heparin plasma on automated Abbott ARCHITECT c8000 analyzer. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for…
Read the full statement (125 words)
DiaSys Procalcitonin FS assay is a particle enhanced immunoturbidimetric test intended for the quantitative in vitro determination of procalcitonin (PCT) in human serum and lithium heparin plasma on automated Abbott ARCHITECT c8000 analyzer.
Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids 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.
The TruCal Procalcitonin Calibrator Set is intended for in vitro use for calibration of the DiaSys Procalcitonin FS assay.
TruLab Procalcitonin Bi-Level Controls are an assayed quality control material for monitoring the performance of quantitative in vitro determination of Procalcitonin (PCT) for the DiaSys Procalcitonin FS assay.
For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242294: DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242294
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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