510(k) · Cleared
Recalled · Class II · 2025Access PCT, Access PCT Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · PTF Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
Cleared on Nov 26, 2019 as substantially equivalent to K162827 (bioMerieux, Inc., 2017) after a 96-day review. Its family tree reaches back 3 generations to 2007. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 26, 2019
- Review
- 96 days
- Class
- Class II
- Product code
- PTF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K071146 (2007). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK071146 Vidas B.R.a.H.M.S. PCT AssaybioMerieux, Inc. · 2007 · Recalled
- 2 generations backK160911 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2016
- 1 generation backK162827 Vidas B.R.a.H.M.S. PCT (PCT)bioMerieux, Inc. · 2017
- This deviceK192271 Access PCT, Access PCT CalibratorsBeckman Coulter, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK222996 Access PCTBeckman Coulter, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222996Access PCTBeckman Coulter, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K071146 | Vidas B.R.a.H.M.S. PCT Assay | bioMerieux, Inc. | 2007 | 1 |
| −2 | K160911 | Vidas B.R.a.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2016 | — |
| −1 | K162827 | Vidas B.R.a.H.M.S. PCT (PCT) | bioMerieux, Inc. | 2017 | — |
| 0 (this device) | K192271 | Access PCT, Access PCT Calibrators | Beckman Coulter, Inc. | 2019 | — |
| +1 | K222996 | Access PCT | Beckman Coulter, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 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 K242294 DiaSys Procalcitonin FS; DiaSys TruCal…score 9.3 · 1 generation · 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 |
|---|---|---|---|
| * | K162827 | Vidas B.R.a.H.M.S. PCT (PCT)Summary page 5…dicate Device: The Access PCT Reagent claims substantial equivalence to the VIDAS® B·R·A·H·M·S PCT®† assay kit by Biomerieux, FDA 510(k) Number K162827, cleared May 31, 2017. Device Description: The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222996 | Access PCT | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 2, 2025 | Class II | Z-1112-2025 | Under Investigation by firm | Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K222996 (Beckman Coulter, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K162827.
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. 2019, 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?
The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of
procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay
Systems. 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 ICU admission for progression to severe sepsis and septic shock.
The Access PCT Calibrators are intended to calibrate the Access PCT assay for the quantitative determination of
procalcitonin levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192271 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192271: Access PCT, Access PCT Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192271
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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