(178 days)
The Safe At Home Test Kit for Monitoring Hemoglobin A1c is intended for home-use or office-use for collection and qualitative determination of hemoglobin A1c in dried whole blood. The product will be marketed over-the-counter.
The Safe at-Home Test Kit for Hemoglobin A1c is intended as a home-use or office-use device for collection of capillary blood for in vitro diagnostic quantitative office ass arrive for oglobin Alc (glycosylated hemoglobin). The device will be used for monitoring long-term glucose control in people with diabetes. This kit is not indicated for the diagnosis of diabetes mellitus.
The device is a kit containing the materials necessary to collect a whole blood sample on a filter paper card and return the card by mail to the laboratory for determination of hemoglobin A1c. The kit comprises of a filter paper card in a resealable shipping bag containing a desiccant pouch, alcohol prep pad, disposable lancets, bandage strip instruction booklet, a return envelope, and a patient test authorization form.
The provided document, K991850, describes the "Safe At Home Test Kit for Monitoring Hemoglobin A1c." Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific numerical acceptance criteria (e.g., minimum correlation coefficient, specific precision ranges). Instead, it broadly states that the studies were designed to evaluate "precision and correlation" and that the "evaluation studies provided evidence that results obtained using blood samples from untrained lay users correlate well with whole blood samples and capillary blood samples collected by trained health care professionals."
A more direct "reported device performance" is also not provided in quantitative detail. The document concludes with a qualitative statement: "Study subjects indicated that the kit is acceptable as designed."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Performance studies were conducted on blood samples collected by both a trained health care professional and the lay user at three different geographical sites." It does not specify the number of samples or participants.
- Data Provenance: The studies were conducted at "three different geographical sites," suggesting a prospective collection of data. The country of origin is not explicitly stated, but given the FDA submission, it's highly likely to be the USA. Data was collected from "lay user" and "a trained health care professional," with venous blood samples collected by the healthcare professional and capillary samples self-collected by patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: The document refers to "a trained health care professional" who collected corresponding venous blood samples. Their specific qualifications (e.g., physician, nurse, phlebotomist) are not detailed.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set. It describes a comparison between samples collected by lay users/healthcare professionals and corresponding venous blood samples.
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, an MRMC comparative effectiveness study was not done. This device is a blood collection kit, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical kit for blood collection and is not an algorithm that operates in a standalone manner. The "performance" refers to the integrity of the collected sample and its correlation with laboratory results.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth appears to be based on laboratory-determined percent hemoglobin A1c from venous blood samples collected by a trained healthcare professional. The document states:
"A corresponding venous blood sample was collected by the health care professional in order to compare whole blood sample results to those obtained from dried blood samples collected on the Safe At Home Kit."
8. The Sample Size for the Training Set
This information is not provided in the document. The concept of a "training set" typically applies to machine learning algorithms, which is not the primary focus of the performance study for this blood collection kit.
9. How the Ground Truth for the Training Set Was Established
This information is not provided as there is no mention of a training set in the context of an algorithm.
§ 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).