(116 days)
EliA Celikey IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to tissue transglutaminase (tTG) in human serum and plasma. EliA Celikey IgG is based on recombinant human tissue transglutaminase as the antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease. EliA Celikey IgG uses the EliA IgG method on the instrument ImmunoCAP 100 and ImmunoCAP 250.
The new device belongs to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate. The total IgG calibration is based on a set of six WHO-standardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method specific and general reagents that are packaged as separate units.
The provided document does not contain details about specific acceptance criteria, comprehensive device performance metrics, or a study specifically comparing the device against acceptance criteria in the format requested. The document is a 510(k) summary for a new device, "EliA™ Celikey IgG," aiming to demonstrate substantial equivalence to a predicate device.
Instead, the document focuses on:
- Intended Use Statement: Describes what the device is designed to measure and its purpose.
- General Description and Test Principle: Explains how the device works.
- Device Comparison and Laboratory Equivalence: Asserts that the new device is comparable to the predicate device based on a comparison study, clinically defined sera, and samples from a normal population.
- FDA Clearance Letter and Indications for Use: Official FDA communication granting clearance and reiterating the intended use.
While the document states that "all available data support that the new device is substantially equivalent to the predicate device," it does not provide a table of acceptance criteria nor the specific performance metrics achieved by the device against such criteria. It also lacks detailed information regarding sample sizes, ground truth establishment methods, or expert qualifications for performance evaluation directly related to acceptance criteria.
The information closest to what was requested is found in the "Laboratory equivalence" section, which broadly states the types of data used for comparison, but without specific performance values or acceptance limits.
Therefore, I cannot fulfill your request for detailed information about acceptance criteria and the study proving the device meets them because that information is not present in the provided text.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).