K203035 is an FDA 510(k) clearance for the Eonis SCID-SMA kit. This device is classified as a Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System (Class II - Special Controls, product code PJI).
Submitted by Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on November 9, 2022, 765 days after receiving the submission on October 5, 2020.
This device falls under the Medical Genetics FDA review panel. Regulated under 21 CFR 866.5930. A Newborn Screening Test For Severe Combined Immunodeficiency (scid) Intended For The Detection Of T-cell Receptor Excision Circle (trec) Genomic Dna Isolated From Newborn Blood Specimens Dried On Filter Paper. It Is Intended As An Aid In Screening Newborns For Severe Combined Immunodeficiency (scid)..
| 510(k) Number | K203035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2020 |
| Decision Date | November 09, 2022 |
| Days to Decision | 765 days |
| Submission Type | Traditional |
| Review Panel | Medical Genetics (MG) |
| Summary | Summary PDF |
| Product Code | PJI - Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5930 |
| Definition | A Newborn Screening Test For Severe Combined Immunodeficiency (scid) Intended For The Detection Of T-cell Receptor Excision Circle (trec) Genomic Dna Isolated From Newborn Blood Specimens Dried On Filter Paper. It Is Intended As An Aid In Screening Newborns For Severe Combined Immunodeficiency (scid). |