(89 days)
Celikey IgG is intended for the semiquantitative and qualitative measurement of anti-tissue transglutaminase (tTG) IgG antibodies in human serum and plasma. Celikey IgG is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease.
Celikey IgG is an indirect noncompetitive enzyme immunoassay for the semiquantitative and qualitative determination of tTG (IgG) antibodies in human serum or plasma. Antibodies specific for tTG present in the patient sample bind to the antigen.
The test kit contains microplate strips coated with purified recombinant human tTG antigen, calibrators, positive and negative controls, enzyme-labeled conjugate, substrate and substrate stop solution, sample diluent and wash buffer.
Here's a breakdown of the acceptance criteria and the study information for the Celikey® IgG tTG Antibody Assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the Celikey® IgG tTG Antibody Assay. Instead, it frames the performance evaluation in terms of comparability to a predicate device and meeting "state-of-the-art expectations" and "medical literature" expectations.
Therefore, the table will reflect the general performance goals described rather than hard numerical thresholds.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Comparability to predicate device (INOVA QUANTA Lite™ h-tTG IgG) in analyzing positive, equivocal, and negative sera. | Supported by data set showing comparability across positive, equivocal, and negative sera. |
| Expected performance for clinically defined sera. | Data shows the assay performs as expected for clinically defined sera. |
| Expected performance for samples from apparently healthy subjects (normal population). | Data shows the assay performs as expected for samples from apparently healthy subjects. |
| Substantial equivalence to the predicate device. | All available data support substantial equivalence to the predicate device. |
| Performance according to state-of-the-art expectations. | All available data support performance according to state-of-the-art expectations. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The text states "a data set including… results obtained within a comparison study analyzing positive, equivocal and negative sera," "results obtained for clinically defined sera," and "results obtained for samples from apparently healthy subjects (normal population)." However, the specific number of samples in each of these categories, or the total sample size for the test set, is not provided in the given document.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study focuses on comparing the new device to a predicate device and clinically defined sera, but it doesn't detail the method of establishing the "ground truth" for those comparisons, nor does it mention expert involvement for this purpose.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No, an MRMC comparative effectiveness study was not performed. This device is an in-vitro diagnostic (IVD) assay designed to measure antibodies, not an imaging device or a device requiring human interpretation of complex visual data where MRMC studies are typically employed to assess reader performance.
- Effect size of human readers with vs. without AI assistance: Not applicable, as this is an IVD assay.
6. Standalone (Algorithm Only) Performance
- Was it done? Yes, in a sense, the primary evaluation presented is of the device's standalone performance. The "comparability study" assesses the Celikey IgG device's ability to produce results akin to the predicate device, and its performance with clinically defined and healthy samples. This is a measure of the algorithm's (or assay's) output without a human in the loop interpreting the raw measurement. The device itself generates the semi-quantitative and qualitative results.
7. Type of Ground Truth Used
Based on the description:
- Comparison to a predicate device: The results from the INOVA QUANTA Lite™ h-tTG IgG assay served as a form of reference or "truth" for comparability.
- Clinically defined sera: This implies that the samples had a known clinical status (e.g., celiac disease positive or negative) established by other diagnostic means (which are not specified but could include biopsy, other antibody tests, or clinical presentation).
- Samples from apparently healthy subjects (normal population): These samples are expected to be negative for the target antibodies, effectively serving as a negative ground truth.
Therefore, the ground truth is a combination of comparison to a legally marketed predicate device and clinically defined (diagnosed) patient status, along with samples from a normal population.
8. Sample Size for the Training Set
This information is not provided in the document. IVD assays like this typically undergo extensive development and validation, but the specific details of a "training set" (in the machine learning sense) are not outlined, nor are the "training" samples or their number explicitly stated.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document, as details about a "training set" for the assay's development or the method of establishing its ground truth are not included.
§ 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).