Automated Blood Coagulation Analyzer CN-Series (CN-6000)

The CN-Series (CN-6000) is a fully automated blood coagulation analyzer for in vitro diagnostic use in clinical laboratories. It analyzes citrated plasma samples from venous blood using clotting, chromogenic, and immunoassay methods to measure prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, antithrombin, and D-dimer. The device is not validated for neonatal or pediatric populations.

The CN-6000 uses the same operating principles as the predicate CS-5100: transmitted light detection at multiple wavelengths (340, 405, 575, 660, or 800 nm), automatic pipetting and dilution, random access capability, and STAT testing. Minor differences include: LED light source (versus halogen lamp), 2 sample probes and 2 reagent probes (versus 3 reagent probes), different cleaning solutions (CN-COAGWASHER versus CA-CLEAN I/II), adjusted reagent cooling temperatures, and 5 sample racks instead of 10.

Method comparison per EP09C 3rd edition CLSI Guideline; precision per CLSI EP05-A3; linearity per CLSI EP06 2nd Edition; interference per optical performance assessment; carryover per CLSI H57-A and EP10-A3-AMD; limit of blank/detection per CLSI EP17-A2 and EP39-ED1; factor sensitivity per CLSI H47 Ed3; hook effect per CLSI EP34-ED1; and reference intervals from three U.S. clinical sites.

The CN-6000 demonstrates substantial equivalence to the CS-5100 predicate because both instruments share identical intended use, sample type (3.2% sodium citrate plasma), reagent applications, and analytical principles. Comprehensive performance testing—including method comparison across three sites, precision studies, linearity, interference, carryover, and stability studies—showed that the CN-6000 results are equivalent to the CS-5100 with high correlation coefficients (r ≥ 0.993 across all assays). The minor hardware differences (light source, probe count, cooling temperatures, rack capacity) do not impact analytical performance, as demonstrated by validated analytical data meeting all pre-established acceptance criteria.