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- MiscellaneousMiscellaneous
- PMIFluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement3Product Code
- PNKFluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)3Product Code
- QUESpinal Muscular Atrophy Newborn Screening Test System2Product Code
- QYOHematopoietic Cell Enrichment Kit2Product Code
- SDPKappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart F—Immunological Test SystemsCFR Sub-Part
- UnknownReview Panel
Spinal Muscular Atrophy Newborn Screening Test System
- Page Type
- Product Code
- 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
- Medical Genetics
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 866.5980
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code QUE is linked to regulation 21CFR866.5980, which does not seem to exist yet. It may be pending at the moment.