510(k) K160729
K160729 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5". The FDA issued a decision of Substantially Equivalent on June 13, 2016. 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. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2016
- Date Received
- March 16, 2016
- 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.