(40 days)
CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2 (Assayed ), is intended for use as an assayed quality control material. Two levels of the control are provided.
CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2 (Unassayed) is intended for use as a quality control material. Two levels of the control are provided.
CLINIQA QALIBRATE™ - CH Chemistry Calibrator is intended for use in assay method calibration for clinical chemistry analyzers .
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for CLINIQA Dry QC™ Chemistry Control and CLINIQA QUALIBRATE™- CH Chemistry Calibrator. This letter grants substantial equivalence, allowing the devices to be marketed. However, it does not contain any information regarding the acceptance criteria, specific performance study details, or ground truth establishment for these devices.
The document is purely an administrative notification of regulatory clearance based on substantial equivalence to a predicate device, and thus does not include the detailed technical study information requested in your prompt.
Therefore, I cannot provide the requested information.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.