Regulatory Pathways (510k) for Test Strips

The regulatory pathway for diabetic test strips in the US is governed by the FDA 510(k) Premarket Notification process for Class II devices. A critical evolution in this pathway occurred with the 2020 Final Guidance, which bifurcated the market into two distinct product codes: NBW for Over-the-Counter Self-Monitoring (SMBG) and PZI for Professional Point-of-Care use (BGMS).

This split was driven by the need for stricter infection control in professional settings and distinct usability requirements for lay users. To achieve clearance, manufacturers must demonstrate substantial equivalence to a predicate device through rigorous performance testing. This includes adhering to accuracy standards (95% of readings within ±15% of reference), validating performance across wide hematocrit ranges, and proving specificity against a mandated list of chemical interferents (e.g., Vitamin C, Maltose). Furthermore, professional systems often require a concurrent CLIA Waiver to allow use in near-patient settings, while modern connected systems must now also satisfy strict cybersecurity and data integrity mandates.