(182 days)
The Carbon Dioxide Standard Kit is an in vitro diagnostic product intended for
calibration or calibration verification of carbon dioxide test systems.
The Urine Chemistry Standard Kit is an in vitro diagnostic product intended for
calibration or calibration verification of clinical chemistry test systems.
The Urine Uric Acid Standard Kit is an in vitro diagnostic product intended for
calibration or calibration verification of clinical chemistry test systems.
The Electrolyte Standard Kit is an in vitro diagnostic product intended for calibration or
calibration verification of serum electrolyte test systems.
The Cholesterol Standard Kit is an in vitro diagnostic product intended for calibration
or calibration verification of clinical chemistry test systems.
The Uric Acid Standard Kit is an in vitro diagnostic product intended for calibration or
calibration verification of clinical chemistry test systems.
The ISE Standard Kit is an in vitro diagnostic product intended for calibration or
calibration verification of clinical chemistry test systems.
The ISE Standard (S4) is an in vitro diagnostic product intended for calibration or
calibration verification of clinical chemistry test systems.
The Multi-Chemistry Standard Kit is an in vitro diagnostic product intended for
calibration or calibration verification of clinical chemistry test systems :
All calibrator materials included in this submission are aqueous, primary standards containing known amounts of each component for in vitro diagnostic use. Standardization is achieved by gravimetric procedure. Verification is performed using available NIST Standard Reference materials.
The provided document is a 510(k) premarket notification for Verichem Laboratories Inc.'s diagnostic calibrators. It describes the properties and intended use of several calibrator kits, including Carbon Dioxide Standard Kit, Urine Chemistry Standard Kit, Urine Uric Acid Standard Kit, Electrolyte Standard Kit, Cholesterol Standard Kit, Uric Acid Standard Kit, ISE Standard Kit, ISE Standard (S4), and Multi-Chemistry Standard Kit.
This document is a regulatory submission for in vitro diagnostic calibrators, not for an AI/ML-based medical device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/ML performance (e.g., sensitivity, specificity, reader studies, ground truth establishment by experts) are not applicable to this type of device.
Instead, the performance of these calibrators is based on analytical performance characteristics, primarily:
- Precision/Reproducibility: Stated as typically
§ 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.