AllTest Viral Transport Medium

The AllTest Viral Transport Medium (VTM) is a 3 mL solution in a polypropylene tube containing Hank's Balanced Salt Solution, fetal bovine serum, glucose, phenol red, gentamicin sulfate, and amphotericin B. It is intended for collection and transport of clinical specimens containing viral agents (Influenza A/B, RSV, Rhinovirus) from collection site to laboratory for viral culture, and for stabilization and transport of upper respiratory specimens suspected of containing SARS-CoV-2 nucleic acid for use with compatible molecular diagnostic devices.

The device shares identical ingredients, plastic tube material, single-use design, and 12-month shelf life with the predicate device. Both support the same viral strains for recovery (Influenza A/B, RSV, Rhinovirus) and SARS-CoV-2 for nucleic acid stability. A minor difference is sample storage temperature: AllTest VTM supports 4-25°C versus the predicate's 2-25°C range.

Not stated in this summary.

Substantial equivalence is established through demonstrated performance equivalence rather than predicate reliance alone. The AllTest VTM achieves >70% viral recovery at 48 hours for all four target viruses at both refrigerated (4°C) and room temperature (23-25°C) storage conditions, matching the predicate's performance profile. Nucleic acid stability testing shows Ct value changes within ±1 Ct at 48 hours for SARS-CoV-2, meeting predefined acceptance criteria. Shelf-life stability testing confirms 12 months at 2-25°C with maintained pH and no microbial contamination, identical to the predicate. The identical formulation, intended use, and demonstrated functional equivalence across viral recovery and nucleic acid stability parameters support substantial equivalence.