510(k) K200236
K200236 is an FDA 510(k) premarket notification submitted by Ortho Clinical Diagnostics for the device "VITROS BRAHMS PCT Reagent Pack and Calibrators". The FDA issued a decision of Substantially Equivalent on February 25, 2020. The device falls under product code PMT (Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens), a Class II device regulated under 21 CFR 866.3215. Ortho Clinical Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 2020
- Date Received
- January 30, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
- Device Class
- Class II
- Regulation Number
- 866.3215
- Review Panel
- MI
- Submission Type
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.