| Device |
spinal muscular atrophy newborn screening test system |
| Definition |
A Spinal Muscular Atrophy (SMA) newborn screening test system is a prescription device intended to detect homozygous deletion of exon 7 or other similar mutations in the SMN1 (Survival Motor Neuron 1) gene of DNA obtained from dried blood spot specimens on filter paper using a polymerase chain reaction-based test as an aid in screening newborns for SMA. Presumptive positive results are intended to be followed up by diagnostic confirmatory testing. |
| Physical State |
May include a multiplex multigene qualitative gene region specific amplification detection test system. The device may include a use for newborn screening. Should not include devices using sequencing-based detection methods. |
| Technical Method |
Uses a multiplex polymerase chain reaction (PCR) to amplify DNA variants located on specific targeted genes using non-sequencing-based methods or with specific nucleic acid sequencing-based detection methods. When using sequencing-based detection methods, variants are identified by comparison to a specified reference sequence. |
| Target Area |
Human clinical specimens |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Molecular Genetics |
|---|
| Product Code | QUE |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.5980
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
