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The Carbon Dioxide Standard Kit is an in vitro diagnostic product intended forcalibration or calibration verification of carbon dioxide test systems.
The Urine Chemistry Standard Kit is an in vitro diagnostic product intended forcalibration or calibration verification of clinical chemistry test systems.
The Urine Uric Acid Standard Kit is an in vitro diagnostic product intended forcalibration or calibration verification of clinical chemistry test systems.
The Electrolyte Standard Kit is an in vitro diagnostic product intended for calibration orcalibration verification of serum electrolyte test systems.
The Cholesterol Standard Kit is an in vitro diagnostic product intended for calibrationor calibration verification of clinical chemistry test systems.
The Uric Acid Standard Kit is an in vitro diagnostic product intended for calibration orcalibration verification of clinical chemistry test systems.
The ISE Standard Kit is an in vitro diagnostic product intended for calibration orcalibration verification of clinical chemistry test systems.
The ISE Standard (S4) is an in vitro diagnostic product intended for calibration orcalibration verification of clinical chemistry test systems.
The Multi-Chemistry Standard Kit is an in vitro diagnostic product intended forcalibration 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 <3.0% coefficient of variation.
• Traceability: Achieved through the use of NIST Standard Reference Materials or equivalent primary standards.
• Value Assignment: Determined by gravimetric procedures using standard source materials of known purity, verified against NIST materials.
• Stability: Monitored through real-time stability studies, with acceptance criteria defined by Verichem's Quality Control End Test Procedure, using freshly prepared identical product as reference and including NIST material.

Therefore, I cannot provide the requested table or information regarding AI/ML-specific study design elements (e.g., sample size for test/training sets, expert consensus, MRMC studies, standalone performance, adjudication methods) because this document does not describe the validation of an AI/ML device.

The document's purpose is to demonstrate substantial equivalence to previously cleared predicate devices based on shared intended use, analytes, manufacturing methods (gravimetric), and analytical performance characteristics relevant to calibrators. The "study" here is primarily a demonstration of adherence to established quality control procedures and traceability standards for chemical calibrants.

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