ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions

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

The cobas c 703 analytical unit in cobas pro differs from the predicate cobas c 503 primarily in throughput (2000 vs 1000 tests/hr), system cycle time (1.8 vs 3.6 seconds), probe configuration (4 vs 2 reagent probes), and reagent storage capacity (70 vs 60 positions). Both use the same absorbance photometry measurement principle, batch/random workflow, and compatible reagent/calibration systems.

Precision testing followed CLSI EP05-A3 guidelines. Analytical sensitivity (LoB, LoD, LoQ) was determined per CLSI EP17-A2. Linearity studies were conducted according to CLSI EP06-Ed2. Method comparison analyses used Passing-Bablok and linear regression approaches.

Substantial equivalence is supported by identical intended use and measurement methodology between the candidate and predicate devices, consistent analytical performance data (precision, sensitivity, linearity) across all sample types, excellent method comparison results (slopes near 1.0, high correlation coefficients), and 100% concordance in qualitative and semi-quantitative clinical sample testing versus established reference methods.