Access PCT
FDA 510(k) K222996 · Beckman Coulter, Inc.
510(k) numberK222996
Submission
- Device name
- Access PCT
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- September 28, 2022
- Decision date
- April 26, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PTF – Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3215
- Specialty
- Microbiology
Assay to measure procalcitonin 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
Other 510(k)s with product code PTF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242294 | DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab…PTF · Traditional | Diasys Diagnostic Systems GmbH | 05/09/2025SE |
| K192271 | Access PCT, Access PCT CalibratorsPTF · Traditional | Beckman Coulter, Inc. | 11/26/2019SE |
| K162297 | Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme…PTF · Traditional | Diazyme Laboratories | 04/18/2017SE |
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| K253687 | Access anti-HBc TotalSEI · Traditional | 02/19/2026SE |
| K251995 | Access anti-HAV IgMLOL · Traditional | 01/27/2026SE |
| K250588 | Access Rubella IgGLFX · Traditional | 11/17/2025SE |
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| K243846 | Access anti-HAVLOL · Traditional | 09/09/2025SE |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | 08/15/2025SE |
| K243483 | Access hsTnIMMI · Traditional | 08/01/2025SE |
Questions and answers
When was Access PCT cleared by the FDA?
Access PCT (K222996) received a 510(k) decision of Substantially Equivalent on April 26, 2023, 210 days after the submission was received.
What is the product code of K222996?
The FDA product code is PTF – Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission, a Class II (moderate risk) device regulated under 21 CFR 866.3215.