(38 days)
RNA1c Control for Bayer DCA2000 and DCA2000+ Analyzers is intended to be used to monitor and evaluate the analytical performance of the Bayer DCA 2000 and DCA 2000+ Analyzers that measure HbA1c. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practice. The two levels of controls allow performance monitoring within the clinically important range.
For In Vitro Diagnostic Use
RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers is a two-level, aqueous liquid control solution consisting of a synthetic peptide identical to the HbA1c epitope in a non-biological aqueous solution with dye to provide the appropriate total hemoglobin value. The concentration of dye and peptide are optimized for use on the Bayer DC A 2000 and DCA 2000+ Analyzers to provide measurement values for HbA1c equivalent to the predicate device, Bayer DCA 2000 Hemoglobin A1c Normal and Abnormal Control Kit.
RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in a plastic bottle with dropper tip for application of the solution to the test cartridge.
RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers is a non-hazardous aqueous solution containing no biological materials and requires no reconstitution prior to use.
The provided text describes the 510(k) summary for the "RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers" device. It outlines the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets those criteria with statistical data.
The document states that "Tests were conducted to verify specific performance requirements: a) Closed bottle stability, b) Stability after opening, c) Correlation to predicate device, d) Test precision and range." It also notes that "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence."
This document is a regulatory submission for substantial equivalence based on comparison to an existing device, rather than a detailed report of a performance study with specific acceptance criteria and outcome data. Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner or report specific performance metrics against such criteria. It generally states that the device provides "measurement values for HbA1c equivalent to the predicate device."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as this is a quality control material and the "ground truth" would be established by the analytical performance of the device it controls, not by human expert assessment. The document does not describe the specific methodology for evaluating the "correlation to predicate device" or "test precision and range."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as this is a quality control material, not an AI diagnostic device for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a control solution, which is used to assess the performance of an analyzer (Bayer DCA 2000 and DCA 2000+ Analyzers). The "standalone" performance here refers to the control's ability to produce consistent results on those analyzers. The document indicates tests were done for "Correlation to predicate device" and "Test precision and range," which implies standalone performance evaluation, but no specific data or methodology is provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a quality control material, the "ground truth" for its performance would typically be the assigned value of the control, established through rigorous testing against reference methods or by comparison to an established predicate. The document states the new device is optimized "to provide measurement values for HbA1c equivalent to the predicate device," suggesting the predicate device's performance provides a reference point.
8. The sample size for the training set
Not applicable, as this is a physical control solution, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of available information regarding acceptance criteria and study:
The document describes the device as a quality control material intended to monitor the analytical performance of HbA1c analyzers. The "study" mentioned consists of non-clinical tests to verify performance requirements through comparison to a predicate device.
| Aspect | Information from Document |
|---|---|
| Acceptance Criteria & Reported Performance | Acceptance Criteria: Not explicitly stated as quantitative thresholds. Implied acceptance is achieving "measurement values for HbA1c equivalent to the predicate device" and meeting stability, precision, and range requirements. |
| Reported Performance: The document concludes that "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence." No specific performance data (e.g., precision coefficients, correlation values, stability data within defined limits) is provided. | |
| Study Type & Purpose | Non-clinical tests were conducted to verify: |
| a) Closed bottle stability | |
| b) Stability after opening | |
| c) Correlation to predicate device | |
| d) Test precision and range | |
| The overall purpose was to demonstrate substantial equivalence to the predicate device (Bayer DCA 2000 Hemoglobin A1c Normal and Abnormal Control Kit [K021484]). | |
| Sample Size (Test Set) | Not provided. |
| Data Provenance | Not provided (e.g., country of origin, retrospective/prospective). |
| Number & Qualifications of Experts (Ground Truth) | Not applicable, as this is a QC material, not expert-interpreted data. |
| Adjudication Method | Not applicable. |
| MRMC Comparative Effectiveness Study | Not applicable. |
| Standalone Performance | Yes, implied by tests for "Correlation to predicate device" and "Test precision and range" for the control solution when used on the specified analyzers. No specific data is given. |
| Type of Ground Truth | The "ground truth" for the control material's values would be established reference values or equivalence to the predicate device's expected performance, likely through analytical methods rather than expert consensus or pathology. |
| Training Set Size | Not applicable (not an AI/ML device). |
| Training Set Ground Truth Establishment | Not applicable. |
§ 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.