(123 days)
The GlycoMark™ test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in serum or plasma. The test is for professional use, and is indicated for the intermediate term monitoring of glycemic control in people with diabetes.
The GlycoMark™ reagents provide for a fully automated enzymatic test for 15AG. The assay requires the two-reagent boxed set (Reagent 1 and Reagent 2) and the 15AG standard (purchased separately). A two-level control set ("Low" and "High") is also available separately.
The provided text describes the 510(k) summary for the GlycoMark™ device. It includes nonclinical and clinical data, but it does not specify acceptance criteria for the device's performance in a traditional sense (e.g., a specific sensitivity or specificity threshold that must be met). Instead, it presents performance characteristics and clinical study results primarily for comparison with a predicate device and to demonstrate safety and effectiveness for its intended use.
However, I can extract the reported device performance and infer "acceptance" by its successful 510(k) clearance by the FDA, implying these performance characteristics were deemed adequate.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since explicit "acceptance criteria" are not stated as quantitative targets that the device must meet (e.g., "sensitivity must be >X%"), I will present the reported performance characteristics. The FDA's clearance (K031604) implies these performance results were acceptable for market entry.
| Characteristic | Inferred Acceptance Criteria (Meeting predicate similarities & clinical relevance) | Reported Device Performance (GlycoMark™) |
|---|---|---|
| Analytical Sensitivity | Should be sufficient to detect clinically relevant levels of 15AG. | 0.2 µg/mL (defined as mean 15AG concentration plus one standard deviation of a saline blank). |
| Within-Assay Precision | Comparable to predicate or clinically acceptable for monitoring. (Predicate: Intra-run %CVs less than 2%) | Between 1.28 %CV and 3.83 %CV at two levels (low 4.6 µg/mL, high 14.7 µg/mL). |
| Between-Assay Precision | Comparable to predicate or clinically acceptable for monitoring. (Predicate: Between-day %CVs between 3% and 4%) | Between 0.79 %CV and 3.71 %CV with two control samples and two serum pool samples (concentrations 4.7 µg/mL to 27.0 µg/mL). |
| Linearity | Should be linear across the expected physiological range of 15AG. | Linear up to at least 110 µg/mL 15AG. |
| Sample Stability | Samples should be stable under appropriate storage conditions for practical laboratory use. | Serum samples stable at room temperature or 2-8°C for up to seven days; endures up to three freeze/thaw cycles. |
| Interfering Substances | Should not be significantly affected by common interfering substances encountered in blood samples. | Not affected by hemoglobin up to 125 mg/dL, triglycerides up to 1153 mg/dL, and bilirubin up to 53.3 mg/dL. |
| Clinical Performance | Should demonstrate responsiveness to changes in glycemic control, similarly to or with advantages over existing markers, for intermediate-term monitoring. | Demonstrated significant changes vs. baseline (p |
§ 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).