Access PCT, Access PCT Calibrators
FDA 510(k) K192271 · Beckman Coulter, Inc.
510(k) numberK192271
Submission
- Device name
- Access PCT, Access PCT Calibrators
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- August 22, 2019
- Decision date
- November 26, 2019
- 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 |
| K222996 | Access PCTPTF · Traditional | Beckman Coulter, Inc. | 04/26/2023SE |
| K162297 | Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme…PTF · Traditional | Diazyme Laboratories | 04/18/2017SE |
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Questions and answers
When was Access PCT, Access PCT Calibrators cleared by the FDA?
Access PCT, Access PCT Calibrators (K192271) received a 510(k) decision of Substantially Equivalent on November 26, 2019, 96 days after the submission was received.
What is the product code of K192271?
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.