(278 days)
The HemoChek-A1c Sample Collection Kit is indicated for over-the-counter sale for use in the measurement of HbA1c on blood specimens which can be collected at the patient's home or at a physician's office on filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over a 10-12 week period. The results are to be evaluated by the patient and their physician. The product is not indicated for the diagnosis of diabetes mellitus.
The HemoChek-A1c Sample Collection Kit is a kit which is purchased by a patient a pharmacy or other retail store. The kit consists of the following:
- A Sample Card containing the proprietary filter paper that the blood sample is placed on and a place for the patient to print his/her name, address, social security number and the sample was collected
- A pamphlet containing detailed instructions about how to obtain a blood sample and mail it to Osborn -Group, Inc.
- A specimen envelope with the words "After blood has dried, insert completed HemoChek test in this envelope. Seal flap and place in envelope" printed on it
- A self-adhesive envelope in which the card is inserted and then mailed to Osborn Group, Inc. -
- A sterile lancet -
- An alcohol swab -
- A gauze pad -
- An adhesive bandage -
- -An outer package containing all of the items listed above
After purchasing the HemoChek-A1c Sample Collection Kit, the patient then prints the required information on the Sample Card and collects a blood sample, using a lancet (either the one provided in the kit, one provided by the patient's physician or one supplied by the patient). The blood sample is placed on both circles on the right hand side of the Sample Card, as described in the instructions. The Sample Card is then placed in the specimen envelope which in turn is placed in the mailing envelope provided in the kit and mailed to Osborn Group, Inc. When the blood sample is received by Osborn Group, Inc., the patient's HbA1c level is measured using existing assay methods. The results are then mailed to the patient.
The provided text is a 510(k) summary for the HemoChek-A1c Sample Collection Kit. This document focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific acceptance criteria and proving performance against them through a detailed study.
Therefore, many of the requested information points (1-9) about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment are not explicitly present in this type of regulatory submission.
Here's an analysis based on the available text:
Acceptance Criteria and Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it asserts "substantial equivalence" to predicate devices. The core "acceptance criteria" in this regulatory context is the demonstration that the new device is as safe and effective as a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | The HemoChek-Atc performs in the same manner as the HemoChek predicate device. |
| Intended Use Equivalence | "The HemoChek-A1c Sample Collection Kit is indicated for over-the-counter sale for use in the measurement of HbA1c on blood specimens which can be collected at the patient's home or at a physician's office on filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over a 10-12 week period. The results are to be evaluated by the patient and their physician. The product is not indicated for the diagnosis of diabetes mellitus." (Identical to predicate's intended use implied) |
| Technological Characteristics Equivalence | "Essentially, the devices use the same basic technology, i.e., collecting a blood sample and analyzing it using an existing assay methodology." (Acknowledges physical size difference and different assay methodologies than one predicate but same as another predicate, implying overall equivalence). |
| Performance Characteristics Equivalence | "Information contained in this submission demonstrates that the HemoChek-Atc performs in the same manner as the HemoChek predicate device." (Specific performance data not provided in this summary). |
2. Sample Size Used for the Test Set and Data Provenance:
- Not explicitly stated. The summary mentions "Information contained in this submission demonstrates..." but does not detail the size of any test set or the provenance of the data (e.g., country of origin, retrospective or prospective). Regulatory submissions for substantial equivalence often rely on various types of data, but the specifics are not in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/Not stated. Ground truth establishment by experts in the context of diagnostic accuracy is not discussed here, as the focus is on substantial equivalence of a sample collection kit. The "ground truth" would likely relate to the accuracy of the HbA1c assay itself, which is a separate established methodology.
4. Adjudication Method for the Test Set:
- Not applicable/Not stated. Since a specific "test set" and a diagnostic accuracy study with multiple readers are not described, an adjudication method is not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is not mentioned as the device is a sample collection kit, not an AI or imaging diagnostic device where MRMC studies are common.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The HemoChek-A1c is a physical sample collection kit, not an algorithm, so a "standalone" performance study in the context of AI is not relevant. The performance evaluation would focus on its ability to collect and preserve samples for subsequent laboratory analysis.
7. The Type of Ground Truth Used:
- Not explicitly stated in relation to device performance. For a sample collection kit, "ground truth" would likely involve the accurate measurement of HbA1c in the lab using established, validated assay methods on samples collected with the kit compared to other methods (e.g., venous blood draw). The summary only states that "the patient's HbA1c level is measured using existing assay methods."
8. The Sample Size for the Training Set:
- Not applicable/Not stated. This refers to machine learning models, which is not the nature of this device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not stated. As above, this pertains to machine learning and not a physical sample collection kit.
Summary of available information:
The document is a 510(k) summary demonstrating substantial equivalence for a medical device (HemoChek-A1c Sample Collection Kit) to existing predicate devices (EZCHEK™/HbA1c Sample Collection Kit and HemoChek Sample Collection Kit). The primary "study" referred to is the submission of information that "demonstrates that the HemoChek-Atc performs in the same manner as the HemoChek predicate device." No specific detailed study, sample sizes, or performance metrics within that study are provided in this summary, as the regulatory path relies on demonstrating similarity to already cleared devices.
§ 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).