(219 days)
CP3000 analyzer: The CP3000 is a fully automated, random-access in vitro blood coagulation analyzer intended for use by healthcare professionals in the clinical laboratory. The CP3000 analyzer is designed to process plasma samples photometrically using chromogenic assays.
Coagpia AT Reagent: Coagpia AT Reagent is intended for the quantitative determination (AT) activity in human 3.2% citrated venous plasma. The reagent is intended for use on Sekisui CP3000 analyzers by trained laboratory personnel in clinical laboratories. For in vitro diagnostic use.
Coagpia Calibrator: The Coagpia Calibrator is intended for use as a calibration plasma for the following Sekisui coagulation assay on Sekisui CP3000 analyzers by trained laboratory personnel in clinical laboratories. For in vitro diagnostic use. - Coagpia AT Reagent
Coagpia Control Set: The Coagpia Control Set contains 2 levels of assaved plasma intended for the following Sekisui coagulation assay on Sekisui CP3000 analyzers by trained laboratory personnel. For in vitro diagnostic use. - Coagpia AT Reagent
CP3000: The CP3000 is designed for easy-to-use, rapid in-vitro blood coagulation testing on citrated human plasma. The CP3000 system is capable of performing the chromogenic methodologic assay, giving the user the ability to perform analysis for both direct hemostasis measurements and calculated parameters. For these assay methodologies, the analyzers employs two photometric detection methods: light scattering and absorbance. The light scattering method uses light emitting diodes at a wavelength of 660 nm, and the absorbance method uses a halogen lamp with filters providing wavelengths at 405/570/730 nm.
Coagpia AT Reagent: Coagpia AT Reagent is intended for the quantitative determination of antithrombin (AT) activity in human plasma on the CP3000 analyzers. The reagent is supplied in a kit of 2 x 10 mL of Reagent 1 and 1 x 10mL of Reagent 2. Both reagents are liquid and do not require any preparation prior to use.
Coagpia Calibrator: The Coagpia Calibrator is supplied as 10 vials of lyophilized human plasma and is suitable for the calibration of the antithrombin activity assay using Coagpia AT Reagent on the CP3000 coagulation analyzers.
Coagpia Control Set: The Coagpia Control Set is supplied as10 vials of lyophilized human plasma; 5 vials of Level 1 Control and 5 vials of Level 2 Control and is suitable for use with the antithrombin activity assay using Coagpia AT Reagent on the CP3000 analyzers.
Here's a breakdown of the acceptance criteria and study information for the CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, and Coagpia Control Set, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (New Device) | Reported Device Performance (Coagpia AT Reagent on CP3000) |
|---|---|---|
| Precision (Coagpia AT Reagent) | ||
| Repeatability (Within-Run) CV | ≤ 10% | 0.7% - 2.9% |
| Between-Run CV | ≤ 10% | 0.8% - 5.1% |
| Between-Day CV | ≤ 10% | 0.0% - 0.4% |
| Between-Lot CV | ≤ 10% | 0.3% - 1.0% |
| Within-Laboratory CV | ≤ 10% | 1.1% - 5.8% |
| Between Instrument CV | ≤ 15% | 0.6% - 4.8% |
| Total CV | ≤ 15% | 1.3% - 7.7% |
| Analytical Sensitivity | ||
| Limit of Quantitation (LOQ) | Total error ≤ 15% | 11% |
| Limit of Blank (LOB) | Not explicitly stated | 3% |
| Limit of Detection (LOD) | Not explicitly stated | 5% |
| Linearity | Allowable non linearity |
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.