(457 days)
The directCHECK® Whole Blood ACT+ Level 1 (normal) and ACT+ Level 2 (abnormal) Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation test: HEMOCHRON® ACT+ assay on the HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite instruments.
The directCHECK® Whole Blood ACT-LR Level 1 (normal) and ACT-LR Level 2 (abnormal) Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation test: HEMOCHRON® ACT-LR assay on the HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite instruments.
The directCHECK® Whole Blood Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation tests. The directCHECK® whole blood control material is prepared from animal plasmas to which fixed animal red blood cells have been added. No human-based materials are contained in directCHECK® Whole Blood Controls. The whole blood control material is lyophilized in glass ampoules, and placed into an individual assembly with liquid diluent. When the glass ampoule is broken (activation of the assembly), the diluent rehydrates the lyophilized material, forming a liquid whole blood control.
The acceptance criteria and study proving device performance are described below based on the provided text.
Acceptance Criteria and Device Performance
Device: directCHECK® Whole Blood Control for HEMOCHRON® ACT+ assay and directCHECK® Whole Blood Control for HEMOCHRON® ACT-LR assay
Study Type: Non-clinical precision and stability testing. Clinical studies were not performed.
| Acceptance Criteria | Reported Device Performance (directCHECK® ACT-LR assay) | Reported Device Performance (directCHECK® ACT+ assay) |
|---|---|---|
| Overall CV for Level 1 ≤ 14% | Overall CV for Level 1 is 14% | Overall CV for Level 1 is 10% |
| Overall CV for Level 2 ≤ 12%[^1] | Overall CV for Level 2 is 10% | Overall CV for Level 2 is 5% |
| Shelf-life Demonstrating 5 months of stability | 5 months of shelf-life for Level 1 and Level 2 | 5 months of shelf-life for Level 1 and Level 2 |
| Room temperature stability demonstrating 4 weeks | 4 weeks for Level 1 and Level 2 | 4 weeks for Level 1 and Level 2 |
Note: The text explicitly states "this satisfies the Level 2 acceptance criteria of CV
§ 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.