# Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
> **Product code: PMT** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3215
## Classification
- **FDA Product Code:** PMT
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3215
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

An assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock.

## Market data
- **Cleared 510(k) submissions:** 5
- **Registered establishments:** 21
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PMT)
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