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 N
| Device Type ID | 3105 |
| Device Name | Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System |
| Physical State | The Test Consists Of Primers And Probes To Amplify And Detect Genomic DNA Obtained From Newborn Peripheral Blood Dried On Filter Paper. The Device Includes Reagents, Instruments, Software And Consumables, And May Integrate Punching Of A Dried Blood S |
| Technical Method | The Test System Uses Primers To Amplify Genomic DNA Obtained From Newborn Peripheral Blood Dried On Filter Paper And Probes To Detect Specific DNA Targets Of Interest. |
| Target Area | Human Peripheral Blood |
| Regulation Description | Newborn Screening Test For Severe Combined Immunodeficiency Disorder (SCID). |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5930 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PJI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3105 |
| Device | Severe Combined Immunodeficiency Disorder (scid) Newborn Screening Test System |
| Product Code | PJI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Newborn Screening Test For Severe Combined Immunodeficiency Disorder (SCID). |
| CFR Regulation Number | 866.5930 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PERKINELMER, INC. | ||
GRANTED | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | PerkinElmer Health Sciences, Inc. | III | Dec-22-2016 |