510(k) K171338
K171338 is an FDA 510(k) premarket notification submitted by Brahms GmbH for the device "B R A H M S PCT sensitive KRYPTOR". The FDA issued a decision of Substantially Equivalent on May 31, 2017. The device falls under product code PRI (Procalcitonin Assay), a Class II device regulated under 21 CFR 866.3215. Brahms GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2017
- Date Received
- May 8, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Procalcitonin Assay
- Device Class
- Class II
- Regulation Number
- 866.3215
- Review Panel
- MI
- Submission Type
To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).