Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions

The cobas pro integrated solutions is an automated analyzer for running qualitative, semiquantitative, and quantitative clinical chemistry and immunochemistry assays. The Glucose HK Gen.3 assay measures glucose in serum, plasma, urine, and CSF for diagnosis and treatment of carbohydrate metabolism disorders. The ONLINE DAT Methadone II assay detects methadone in urine at a 300 ng/mL cutoff for drug screening purposes.

The candidate cobas c 703 analytical unit differs from the predicate cobas c 503 primarily in throughput (2000 vs 1000 tests/hour), cycle time (1.8 vs 3.6 seconds), reagent probe count (4 vs 2), sample probe count (2 vs 1-2), onboard reagent storage (70 vs 60 positions), and light source (LED vs tungsten/halogen). All other measurement principles, workflow, sample handling, detection methods, and software remain identical.

The submissions cite CLSI standards including EP05-A3 (precision), EP17-A2 (analytical sensitivity/LoB/LoD/LoQ), and EP06-Ed2 (linearity). ISO 13485 is referenced for quality management system requirements. No other consensus standards (ASTM, IEC) are explicitly detailed in this summary.

Substantial equivalence is based on identical intended use and measurement principles between the candidate and predicate devices; comprehensive analytical performance data demonstrating acceptable precision, linearity, sensitivity, and method comparison to the predicate; and demonstration that technical differences (throughput, cycle time, probe configuration) do not adversely affect performance. Both assays showed excellent correlation and agreement with predicate and reference methods across all sample types and clinical matrices tested.