(15 days)
Clinical laboratories, performing immunoassays for drugs, hormones and proteins on automated immunoassay systems may use Qualitrol Immunoassay DHP Control or CONFORMANCE MCC-Ligand Control routinely as a means of estimating precision and monitoring test system performance, provided:
(a) the above mentioned controls, provided as a set (Levels 1, 2 3) are used as an adjunct to primary control procedure and recommended by the manufacturer of immunoassay systems.
(b) above mentioned controls are used in accordance with the quality control requirements of regulatory and/or accrediting organizations and laboratory's quality control goals;
(c ) above mentioned controls are validated for use with the specific immunoassay test system being used by the clinical laboratory.
These controls have been assayed with AxSYM, IMx and TDX systems manufactured by Abbott Laboratories (Abbott Park, USA). The expected values, for these systems, are included in the package insert. The controls may be used as assayed controls for the stated indication for use when measurements are made with above-mentioned immunoassay systems.
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This is an FDA Premarket Notification (510k) letter for a device called "Qualitrol DHP Immunoassay Control Levels 1, 2, and 3". As such, the purpose of this document is to establish substantial equivalence to a predicate device, not to present a study proving the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity. There is no information provided in this document that would allow for the completion of the requested table and study details.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."
The "Indication for Use" section describes how the control solution should be used (e.g., as an adjunct to primary control procedures, in accordance with quality control requirements, and validated for the specific immunoassay system). It also mentions that the controls have been assayed with specific immunoassay systems (AxSYM, IMx, and TDX systems manufactured by Abbott Laboratories) and that expected values are included in the package insert. However, this does not constitute a study with acceptance criteria and performance metrics for the control device itself in the way typically expected for a diagnostic or AI-enabled device.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets those criteria, as this information is not present in the provided document.
§ 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.