K192271 is an FDA 510(k) clearance for the Access PCT, Access PCT Calibrators. This device is classified as a Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission (Class II - Special Controls, product code PTF).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on November 26, 2019, 96 days after receiving the submission on August 22, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3215. 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.
| 510(k) Number | K192271 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2019 |
| Decision Date | November 26, 2019 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| 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 - Special Controls |
| CFR Regulation | 21 CFR 866.3215 |
| Definition | 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 |