510(k) K213396
K213396 is an FDA 510(k) premarket notification submitted by Helena Laboratories, Corp. for the device "SPIFE A1AT kit". The FDA issued a decision of Substantially Equivalent on October 13, 2022. The device falls under product code OBZ (Alpha-1-Antitrypsin Kit, Qualitative Phenotype), a Class II device regulated under 21 CFR 866.5130. Helena Laboratories, Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 2022
- Date Received
- October 18, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alpha-1-Antitrypsin Kit, Qualitative Phenotype
- Device Class
- Class II
- Regulation Number
- 866.5130
- Review Panel
- IM
- Submission Type
The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only.