(203 days)
The Dimension® Hemoglobin A1c assay is an in vitro diagnostic assay for the quantitative determination of %HbA 1c (DCCT/NGSP) and mmol/mol HbA1c (IFCC) in human anticoagulated venous whole blood for use on the Dimension® clinical chemistry system. Measurement of Hemoglobin A1c is used as an aid in diagnosis and monitoring of long-term blood glucose control in patients with diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.
The Dimension® Hemoglobin A1C assay is an in vitro diagnostic device intended to measure the concentration of hemoglobin A1c in venous human anticoagulated whole blood. The assay consists of three reagents packaged in Dimension® Flex® cartridges. The reagents are liquid and ready to use.
The provided text describes the Siemens Healthcare Diagnostics Inc.'s Dimension® Hemoglobin A1c Assay, a Class II medical device for quantitative determination of %HbA1c and mmol/mol HbA1c in human anticoagulated venous whole blood. The document details studies undertaken to demonstrate the device's performance, primarily for a 510(k) premarket notification to show substantial equivalence to a predicate device.
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1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets for each performance characteristic. Instead, it presents study results and, for some criteria, qualitative conclusions (e.g., "No significant interference," "No deviations from linearity"). The assessment of "substantial equivalence" to the predicate device implies that the reported performance meets acceptable clinical standards for HbA1c measurement.
| Performance Metric | Acceptance Criteria (Implied / Qualitative) | Reported Device Performance |
|---|---|---|
| Method Comparison (against NGSP Reference Method) | Agreement with NGSP reference method; low bias. | Passing-Bablok: Slope [0.966 to 1.001], Y-int [-0.095 to 0.144] (%HbA1c); Bias at decision levels: -1.10% to -1.45% (%HbA1c) |
| Deming: Slope [0.957 to 1.000], Y-int [-0.094 to 0.198] (%HbA1c); Bias at decision levels: -1.16% to -1.77% (%HbA1c) | ||
| Precision | Low variability (Repeatability, Between-Run, Between-Day, Between-Instrument, Between-Lot, Total CV). | Total CV: 1.7% to 2.6% for %HbA1c (QC samples), 1.6% to 2.4% for %HbA1c (patient pools) |
| Total Error | Acceptable total error at decision levels. | Ranged from 4.4% to 5.8% (%TE) for %HbA1c at various decision levels. |
| Endogenous & Exogenous Interference | No significant interference (e.g., |
§ 862.1373 Hemoglobin A1c test system.
(a)
Identification. A hemoglobin A1c test system is a device used to measure the percentage concentration of hemoglobin A1c in blood. Measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA.
(2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity, and interference, including the following:
(i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0 percent, 6.5 percent, 8.0 percent, and 12 percent hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least three lots of the device and three instruments, as applicable.
(ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method. Results must demonstrate little or no bias versus the standardized method.
(iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6 percent.
(iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S.
(3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations.