(47 days)
The LOCI THYR CAL is an in vitro diagnostic product for the calibration of the LOCI Free Triiodothyronine (FT3), LOCI Free Thyroxine (FT4L) and LOCI Thyroid Stimulating Hormone (TSHL) methods on the Dimension® EXL™ integrated chemistry system with LOCI® Module.
The LOCITHYR CAL is a multi-analyte, liquid, bovine serum albumin based product containing triiodothyronine, thyroxine and human thyroid stimulating hormone. The kit consists of ten vials with two vials per level containing 2.0 mL per vial.
The provided text describes a 510(k) summary for the LOCI Thyroid Calibrator, focusing on its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details about the study that proves the device meets acceptance criteria based only on the provided input.
The document primarily states:
- The device is a calibrator for specific thyroid hormone tests.
- It is substantially equivalent to a previously cleared device (K073604).
- The key difference from the predicate is the addition of calibration for "Free Triiodothyronine (FT3)".
To answer your request thoroughly, I would need a different type of document, such as a full. 510(k) submission, a clinical study report, or a validation study report that details performance characteristics and acceptance criteria.
§ 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.