Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
FDA 510(k) K162297 · Diazyme Laboratories
510(k) numberK162297
Submission
- Device name
- Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
- Applicant
- Diazyme Laboratories
Poway, CA, US - Received
- August 16, 2016
- Decision date
- April 18, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K192271 | Access PCT, Access PCT CalibratorsPTF · Traditional | Beckman Coulter, Inc. | 11/26/2019SE |
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Questions and answers
When was Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set cleared by the FDA?
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set (K162297) received a 510(k) decision of Substantially Equivalent on April 18, 2017, 245 days after the submission was received.
What is the product code of K162297?
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.