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The Destiny Max Coagulation Analyzer is a multipurpose system for in vitro coagulation studies consisting of one automated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

The Destiny Max instrument performs coagulation testing (clotting, chromogenic and immuno-turbidimetric) using human samples. The system is comprised of an instrument (Destiny Max Analyzer) that performs the tasks necessary to general an assay result together with a Personal Computer (PC) that receives the user's secueeds and provides the results. The assays used with the Destiny Max are generally requences detection of clotting deficiencies or disorders and/or monitoring of anticoagalant therapy on various patient populations.

The Trinity Biotech Destiny MAX Coagulation Analyzer is a multipurpose system for in vitro coagulation studies. Its acceptance criteria and performance are detailed through a method comparison study and precision studies.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided document. However, the performance is reported through method comparison against a predicate device (AMAX Destiny) and precision data, implying an expectation of strong correlation (for method comparison) and low variability (for precision).

Method Comparison (Slope, Intercept, R/R² values):
The device performance is reported across various assays (TriniCLOT PT HTF, TriniCLOT Excel S, TriniCLOT APTT S, TriniCLOT Thrombin Time, TriniCLOT Fibrinogen, TriniCLOT FVII, TriniCLOT FIX, TriniCHROM Antithrombin IIa, TriniLIA D-Dimer) in both optical and mechanical modes (where applicable). The reported R or R² values are consistently high, ranging from 0.88 to 1.00. Slopes are generally close to 1 and intercepts close to 0, indicating strong correlation and agreement with the predicate device.

Linearity (R values):
For linearity, the reported R values are all very high, ranging from 0.993 to 1.000.

Precision (%CV values):
Precision is assessed at different levels for each assay and mode, with "Within Run" and "Total" %CVs reported. The %CV values generally range from 0.6% to 24.2%, depending on the assay, level, and mode. For most clotting assays (PT, APTT, Thrombin Time), the %CVs are often below 5%. For Fibrinogen, FVII, FIX, Antithrombin, and D-Dimer, some %CVs are higher, particularly at lower concentrations or for “Total” precision.

Since specific acceptance criteria were not explicitly stated (e.g., "R² must be > 0.95" or "%CV must be

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