510(k) K192858
K192858 is an FDA 510(k) premarket notification submitted by Progenika Biopharma S.A., A Grifols Company for the device "A1AT Genotyping Test". The FDA issued a decision of Substantially Equivalent on November 5, 2019. The device falls under product code PZH (Serpina1 Variant Detection System), a Class II device regulated under 21 CFR 866.5130. Progenika Biopharma S.A., A Grifols Company has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 2019
- Date Received
- October 4, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Serpina1 Variant Detection System
- Device Class
- Class II
- Regulation Number
- 866.5130
- Review Panel
- IM
- Submission Type
This is a qualitative DNA detection in vitro diagnostic test to be used in conjunction with a visualization instrument and its software. This test is for the simultaneous detection and identification of allelic variants found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. This assessment system provides users with genetic information regarding genotypes of SERPINA1 allelic variants and is intended to be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of individuals with A1AT deficiency.