(94 days)
The Randox Laboratories Limited Liquid Protein Calibrator (for neat sample assays) is derived from normal human serum obtained from volunteer donors. It has been developed for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin, Transferrin and Haptoglobin assays (all neat sample assavs).
Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to International Reference Material CRM 470. The constituent concentrations of these Calibrators are present at levels 1, 2, 3, 4 and 5.
This calibrator can be used on Abbott Spectrum, Abbott aeroset, Abbott Architect ഗ്രാമം Architect i2000sr, Ace Analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, Olympus AU800, AU600, AU400, AU2700, AU5400, Selectra vitalab, Synchron CX4 Synchron CX5 Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira plus systems
The Randox Laboratories Limited Liquid Protein Calibrators, should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
For in vitro diagnostic use.
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This document is a 510(k) premarket notification letter from the FDA to Randox Laboratories, Ltd. for their "Randox Liquid Protein Calibrators (For Neat Sample Assays)". The letter determines that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device. It's for an in vitro diagnostic (IVD) calibrator, which is a different type of medical device with different regulatory requirements and evaluation methods.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study demonstrating performance, an MRMC study, sample sizes for training/test sets, or ground truth establishment relevant to an AI/ML device. That information is not present in this 510(k) letter for a calibrator.
§ 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.