iQ200 Series

The iQ200 System is an in vitro diagnostic device that automates urinalysis by combining urine test strip chemistry analysis with microscopic sediment analysis. It uses automated particle recognition software to classify and count formed elements in urine (cells, casts, crystals, organisms) with results that can be auto-reported or reviewed by technologists before upload to laboratory information systems.

The iQ200 uses a specimen sandwiched between lamina layers presented to a microscope with CCD video camera for precise focusing and field of view. The Auto-Particle Recognition (APR) software classifies particle images into 12 main categories with 27 additional sub-classifications. The primary change in this submission is discontinuation of the optional Lamina Cradle accessory introduced in predicate K093861, which does not affect the core technological design, materials, chemical composition, principle of operation, or energy source.

Not stated in this summary.

The iQ200 System maintains identical indications for use as the previously cleared predicate devices (K022774, K093861, K210127). The sole modification is discontinuation of an optional accessory (Lamina Cradle), which does not constitute a new intended use and has no impact on the technological characteristics or performance of the device itself. Since the indications for use remain unchanged and no design or operational parameters of the core device were modified, the device is substantially equivalent to its predicate.