(7 days)
Abbott Liquid Pediatric Chemistry Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.
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The provided document is a 510(k) premarket notification letter from the FDA for the "Abbott Liquid Pediatric Chemistry Control" device. This device is a quality control material and not an AI/ML medical device. Therefore, the information requested in the prompt (acceptance criteria, study details, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) related to AI/ML device evaluation is not applicable to this document.
The document only states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to a device already on the market. The FDA's review in this case focuses on equivalence, not on a detailed performance study with acceptance criteria as would be required for a novel AI/ML device.
§ 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.