K213396 is an FDA 510(k) clearance for the SPIFE A1AT kit. This device is classified as a Alpha-1-antitrypsin Kit, Qualitative Phenotype (Class II - Special Controls, product code OBZ).
Submitted by Helena Laboratories, Corp. (Beaumont, US). The FDA issued a Cleared decision on October 13, 2022, 360 days after receiving the submission on October 18, 2021.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5130. 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..
| 510(k) Number | K213396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2021 |
| Decision Date | October 13, 2022 |
| Days to Decision | 360 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | OBZ — Alpha-1-antitrypsin Kit, Qualitative Phenotype |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5130 |
| Definition | 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. |