(29 days)
The PTS PANELS Multi-Chemistry Controls are intended for use to estimate precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation and are intended for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing as well as consumers at home.
The PTS PANELS Multi-Chemistry Controls are intended for use on the BioScanner 2000 and CardioChek brand instruments to estimate precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation and are intended for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing as well as consumers at home.
The PTS PANELS Multi-Chemistry Controls consist of multiple levels of aqueous controls containing cholesterol, triglycerides, ketone (Bhydroxybutyrate) and glucose.
The provided text describes a 510(k) submission for "PTS PANELS Multi-Chemistry Controls" and the FDA's clearance. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document details:
- Applicant Information: Polymer Technology Systems, Inc.
- Device Description: Aqueous controls containing cholesterol, triglycerides, ketone (B-hydroxybutyrate), and glucose.
- Intended Use: To estimate precision and detect systematic analytical deviations from reagent or instrument variation, for use by healthcare professionals and consumers.
- Predicate Devices: Maine Standards Validate Chem 1 and Chem 3.
- Similarities and Differences between the new device and the predicate devices, primarily regarding the analytes included and the base matrix (aqueous vs. protein-based for one predicate).
- FDA Clearance Letter: Indicating substantial equivalence to marketed predicate devices.
Therefore, I cannot provide the requested table or answer the questions regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.
§ 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.