Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)

The Alinity m SARS-CoV-2 is a real-time RT-PCR assay for qualitative detection of SARS-CoV-2 nucleic acid in nasopharyngeal and anterior nasal swab specimens from patients with signs and symptoms of COVID-19. It is used with the automated Alinity m System and is intended as an aid in COVID-19 diagnosis when used in conjunction with clinical, epidemiologic, and laboratory findings.

Both the Alinity m SARS-CoV-2 and predicate use real-time RT-PCR technology with fully automated sample preparation, amplification, and detection. Key differences include: the Alinity m uses magnetic microparticles for nucleic acid capture versus the predicate's magnetic glass particles; the Alinity m reports results as 'Not Detected' or copy number (CN) positive versus the predicate's multi-target reporting (Target 1/2 combinations); and specimen collection options differ slightly between the two systems.

Not stated in this summary.

Substantial equivalence is supported by: (1) identical intended use and specimen types (NP and nasal swabs); (2) same regulatory class II and product code QQX; (3) comparable analytical performance—limit of detection of 0.009 TCID₅₀/mL for NP swabs and 0.0180 TCID₅₀/mL for nasal swabs; (4) high precision (>99% agreement across instruments, operators, and kit lots) and reproducibility (100% agreement for positive panels across sites); (5) no cross-reactivity with 40+ microorganisms or interference from 34 potentially interfering substances; and (6) strong clinical performance with 96.3–100% positive percent agreement and 95.2–99.7% negative percent agreement versus composite comparator assays across different specimen types and collection methods.