510(k) DEN190023
DEN190023 is an FDA 510(k) premarket notification submitted by Asuragen, Inc. for the device "AmplideX Fragile X Dx & Carrier Screen Kit". The FDA issued a decision of De Novo Granted on February 21, 2020. The device falls under product code OYV (Inherited Nucleotide Repeat Disorder Dna Test), a Class II device regulated under 21 CFR 866.5970. Asuragen, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 21, 2020
- Date Received
- April 18, 2019
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Inherited Nucleotide Repeat Disorder Dna Test
- Device Class
- Class II
- Regulation Number
- 866.5970
- Review Panel
- PA
- Submission Type
An inherited nucleotide repeat disorder DNA test is a prescription in vitro diagnostic test that is intended to detect and identify the number of nucleotide repeats in a gene using genomic DNA isolated from post-natal patient specimens. It is solely intended as an aid for carrier testing and as an aid for the diagnosis of inherited nucleotide repeat-associated disorders. Assay results are solely intended to be used in conjunction with other clinical and diagnostic findings. These tests do not include those indicated for use for fetal diagnostic testing or newborn screening.