Comparison:Article Title:
Article Snippet: .. Comparison with predicate: Similarities / Differences Item FRENDTM Free T4 Test System ( Candidate Device) Abbott Architect Free T4 (Predicate device) k123379 Intended Use For the quantitative determination of Free T4 (FT4) levels in serum and plasma Same Assay Methodology Fluorescent immunoassay Chemiluminescent immunoassay Sample Type Serum and Lithium heparin plasma Same Measuring range 0.40 – 6.00 ng/dL Same Calibrators All calibration statistics and information have been electronically stored on the FRENDTM Free T4 Code chip included in each box of FRENDTM Free T4 cartridges. .. 6-point calibration 6 levels 0.0, 0.5, 1.0, 2.0, 3.5, 6.0 ng/dL Antibody Monoclonal mouse anti-T4 Polyclonal sheep anti-T4 K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures CLSI EP06-A: Evaluation of the Linearity of Quantitative Measurement Procedure CLSI EP07-A2: Interference Testing in Clinical Chemistry CLSI EP09-A3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples CLSI EP14-A3: Evaluation of Commutability of Proceeded Samples CLSI EP17-A2: Evaluation of Detection Capabilities for Clinical Laboratory Measurement Procedures Quantitation CLSI EP25-A: Evaluation of Stability of In Vitro Diagnostic Reagents CLSI EP28-A3: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory L. Test Principle: The FRENDTM Free T4 Test utilizes microfluidic technology and detects immune complexes bound to FT4.
Clinical Proteomics:Article Title:
Article Snippet: .. Comparison with predicate: Similarities / Differences Item FRENDTM Free T4 Test System ( Candidate Device) Abbott Architect Free T4 (Predicate device) k123379 Intended Use For the quantitative determination of Free T4 (FT4) levels in serum and plasma Same Assay Methodology Fluorescent immunoassay Chemiluminescent immunoassay Sample Type Serum and Lithium heparin plasma Same Measuring range 0.40 – 6.00 ng/dL Same Calibrators All calibration statistics and information have been electronically stored on the FRENDTM Free T4 Code chip included in each box of FRENDTM Free T4 cartridges. .. 6-point calibration 6 levels 0.0, 0.5, 1.0, 2.0, 3.5, 6.0 ng/dL Antibody Monoclonal mouse anti-T4 Polyclonal sheep anti-T4 K. Standard/Guidance Document Referenced (if applicable): CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures CLSI EP06-A: Evaluation of the Linearity of Quantitative Measurement Procedure CLSI EP07-A2: Interference Testing in Clinical Chemistry CLSI EP09-A3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples CLSI EP14-A3: Evaluation of Commutability of Proceeded Samples CLSI EP17-A2: Evaluation of Detection Capabilities for Clinical Laboratory Measurement Procedures Quantitation CLSI EP25-A: Evaluation of Stability of In Vitro Diagnostic Reagents CLSI EP28-A3: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory L. Test Principle: The FRENDTM Free T4 Test utilizes microfluidic technology and detects immune complexes bound to FT4.
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