21 CFR 866.5980 — Spinal Muscular Atrophy Newborn Screening Test System

Immunology (IM) · De Novo Classifications · § 866.5980

Identification

The Eonis SCID-SMA kit is a multiplex real-time PCR-based assay intended for the qualitative detection of the SMN1 gene exon 7 as an aid in screening newborns for Spinal Muscular Atrophy (SMA). The test is intended for DNA from blood specimens dried on a filter paper and for use on the QuantStudio Dx Real-Time PCR instrument. It is intended for screening of SMA that bear the homozygous deletion of SMN1 exon 7 and is not intended for use as a diagnostic test.

Classification Rationale

Class II (special controls). The device is subject to the special controls identified in the De Novo classification order to mitigate risks of false positive and false negative results.

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