(36 days)
Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for Hemoglobin A1c and methods listed in this package insert.
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This regulatory document is a 510(k) clearance letter from the FDA for a quality control material used in diabetes testing. It does not contain information about acceptance criteria or a study proving a device meets them in the way typically found for an AI/ML medical device.
The document pertains to a "Quality control material (assayed and unassayed)" and states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This is a Class I device, which generally means it poses the lowest risk and is subject to general controls, not typically requiring extensive clinical studies to demonstrate performance against specific acceptance criteria like an AI diagnostic algorithm would.
Therefore, I cannot provide the requested information for the following reasons:
- No specific acceptance criteria or performance metrics are listed: The document is a clearance letter, not a detailed technical report or study summary. It doesn't define quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy) because it's a quality control material rather than a diagnostic device that directly interprets patient data.
- No study details provided: The letter states "we have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent." This determination is based on a comparison to existing predicate devices, implying that detailed performance studies as understood for AI/ML devices were not necessary for this type of product and regulatory pathway.
- No AI/ML component: The device is a "Liquid Assayed Diabetes Control," a chemical reagent used for quality control, not an AI/ML algorithm or software. Therefore, concepts like "test set," "training set," "ground truth experts," "adjudication," or "human-in-the-loop performance" are not applicable.
In summary, the provided text is an FDA clearance letter for a quality control material. It does not provide the kind of performance data or study details required to answer your specific questions regarding acceptance criteria and study methodologies, particularly in the context of AI/ML device evaluation.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.