(85 days)
The IDS-iSYS CTX-I (Crosslaps) Control Set is intended for medical purposes for use in the IDS-iSYS CTX-I (Crosslaps) Assay on the IDS-iSYS Multi-Discipline Automated Analyser to monitor the accuracy and quality of the IDS-iSYS CTX-I (Crosslaps) Assay.
The IDS-iSYS 25-Hydroxy Vitamin D Calibration Verifiers are intended for use in the quantitative verification of calibration and assay range of the IDS-iSYS 25-Hydroxy Vitamin D Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
The IDS-iSYS CTX-I (CrossLaps) Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration and assay range of the IDS-iSYS CTX-I (CrossLaps®) Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
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This is a 510(k) premarket notification for in vitro diagnostic device calibration verifiers and control sets, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable and cannot be extracted from this document.
The document discusses the substantial equivalence of the "IDS-iSYS CTX-I (Crosslaps®) Calibration Verifiers, IDS-iSYS 25 Hydroxy Vitamin D Calibration Verifiers, and IDS-iSyS CTX-I (Crosslaps®) Control Set" to legally marketed predicate devices. It focuses on regulatory requirements for in vitro diagnostic devices, such as general controls, labeling, and manufacturing practices.
§ 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.