(27 days)
Elecsys CalCheck T Uptake is intended for use in the quantitative verification of the calibration curve established by the Elecsys T Uptake reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
The Elecsys CalCheck T Uptake is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values.
This document is a 510(k) summary for a medical device called "Elecsys® CalCheck™ T Uptake." It describes the device, its intended use, and its comparison to a predicate device. However, the provided text does not contain any information about acceptance criteria or a study proving that the device meets those criteria.
Specifically, the document focuses on:
- Introduction and Submitter Information: Standard administrative details.
- Device Name and Classification: Identifying the proprietary and common names, and classification.
- Predicate Device: Stating the device to which substantial equivalence is claimed (Tosoh Medic AIA-Pack HCG Calibration Verification Test Set, K924862).
- Device Description: Explaining that it's a three-level single analyte set of lyophilized, human-based materials assayed in triplicate and compared to target values.
- Intended Use: For quantitative verification of the calibration curve established by Elecsys T Uptake reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
- Comparison to Predicate: Reaffirming substantial equivalence based on the same intended use.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies, as it 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.