(166 days)
The Accu-Chek A1c Hemoglobin Test is designed for use with BMC Hitachi reagents that measure glycosylated hemoglobin. The test has not been evaluated using any other methodology. The device is intended for at-home or in-office use to collect a whole blood sample. The product will be marketed over-the-counter. Test results should be evaluated together with a personal doctor.
Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient. This product is not indicated for the diagnosis of diabetes mellitus.
The device is a kit containing the materials required to collect a whole blood sample on a test strip and mail it to a laboratory for determination of Hemoglobin A1c. The kit contains test strips, disposable lancets, instructions booklet, other related labeling, a return envelope, and a patient identification card for returning a result to the patient and/or his/her doctor.
The provided text describes a 510(k) premarket notification for the Accu-Chek A1c™ Hemoglobin Test. This device is a kit for collecting a whole blood sample for Hemoglobin A1c testing, intended for at-home or in-office use.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria for the Accu-Chek A1c™ Hemoglobin Test itself. Instead, it focuses on demonstrating that the accessory device's sample collection method does not negatively impact the performance of the analytical assay (Tina Quant Hemoglobin A1c Assay) and provides acceptable user experience.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Correlation with professional sample collection: Samples collected using the accessory device by untrained laypersons should correlate well with whole blood samples collected and handled directly by healthcare professionals. | "evaluation studies provide evidence that results produced using samples collected by untrained lay persons using the accessory device correlate well with whole blood samples collected and handled directly by health care professionals" |
| Ease of Use/User Acceptance: The kit should be easy for users to understand and operate. | "Study participants indicated that the kit is acceptable as designed." "Study participants filled out questionnaires regarding the ease of use." |
| Reagent and Sample Stability: The collected samples and reagents should remain stable under expected environmental conditions. | "the Accu-Chek A1c Hemoglobin Test was evaluated for reagent and sample stability when exposed to abusive environmental conditions." (No specific results provided, but implies satisfactory stability was met). |
| Unaffected analytical and post-analytical stages: The use of the accessory device should not alter the performance characteristics of the Tina Quant Hemoglobin A1c assay beyond the pre-analytical stage. | "All procedural steps and performance specifications associated with the analytical and post analytical stages of the assay are unaffected by the introduction of this accessory device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document only mentions "user studies" and "study participants." The specific number of participants in these studies is not provided.
- Data Provenance: The studies were described as "actual use situations (user studies)." This implies the data was collected prospectively from participants following the instructions for the device's intended use. The country of origin is not specified, but given the submitter is "Boehringer Mannheim Corporation" in "Indianapolis, IN," it is reasonable to infer the studies were conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those experts
- For evaluating the correlation, samples collected by "health care professionals" are used as the reference. The number of such professionals or their specific qualifications (e.g., radiologist with 10 years of experience) is not specified.
- For the 'ease of use' aspect, the ground truth is "user indications" from "study participants" via "questionnaires." These participants are described as "untrained lay persons."
4. Adjudication Method for the Test Set
- The document does not describe any formal adjudication method (e.g., 2+1, 3+1). The evaluation seems to rely on direct comparison of results and participant feedback.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a sample collection kit, not an AI-assisted diagnostic tool that would involve human readers interpreting results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a sample collection kit, not an algorithm. The core analytical performance is tied to the Tina Quant Hemoglobin A1c Assay, which is a chemical assay, not an algorithm. The device itself is an accessory that facilitates sample collection for that assay.
7. The Type of Ground Truth Used
- The ground truth for the correlation study appears to be measurements from whole blood samples collected and handled directly by health care professionals using the established Tina Quant Hemoglobin A1c Assay procedure.
- The ground truth for the ease of use study is user feedback/responses from questionnaires.
8. The Sample Size for the Training Set
- The document does not mention a training set. This is expected as the device is a sample collection kit and not a machine learning or AI-based system that would typically require a training set. The "evaluation studies" describe validation, not training.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable as there is no mention of a training set.
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).