(521 days)
The CLOVER Alc HbAlc assay is an in vitro diagnostic test that quantitatively measures the percent concentration glycosylated hemoglobin in capillary or venous whole blood samples for clinical laboratory and point of care use. Measurement of percent HbAlc is used to monitor long-term glucose control in individuals with diabetes mellitus. CLOVER Alcim is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.
The CLOVER Alc 11 glucose assay is used for the quantitative measurement of the concentration of glucose in whole blood taken from the fingertip by healthcare professionals. The test is for prescription use as an aid in the management of diabetes. CLOVER Alc 10 is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.
The CLOVER A1cm is a device which combines a Hemoglobin A1c monitoring system, and a blood glucose monitoring system.
The CLOVER A1c™ monitoring system includes Hemoglobin A1c Analyzer, Hemoglobin A1c Test cartridge, Hemoglobin A1c Check cartridge, Thermal printer, Barcode scanner, PC cable, and Fan filter.
The CLOVER A1c™ monitoring system is a fully automated boronate affinity assay for the determination of the percentage of hemogiobin A1c (HbA1c %) in human whole blood.
Hemoglobin A1c Test cartridge is composed of a cartridge and a reagent pack containing the reagents necessary for the determination of hemoglobin A1c, with a collection leg for blood sample collection.
The reagent pack is pre-filled with reaction solution and washing solution. The reaction solution contains agents that lyse erythrocytes and bind hemoglobin specifically, as well as a boronate resin that binds cis-diols of glycated hemoglobin.
Blood sample is collected at the collection leg of the reagent pack, and then the reagent pack is inserted into the cartridge. The assembled cartridge is inserted into the Hemoglobin A1c Analyzer and rotated so that the blood sample mixture is placed at the measurement zone of the cartridge, where the amount of total hemoglobin in the blood sample is photometrically measured. The measurement range is 4.0~14.0%. Acceptable anticoagulants for venous samples are EDTA, heparin, citrate and fluoride/oxalate.
The CLOVER A1c™ Glucose module is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood. The principle of the test replies upon a specific type of glucose in blood sample, the oxidase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generation an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
The provided text is a 510(k) summary for the CLOVER A1c™ Glycosylated Hemoglobin Monitoring System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data. However, it does not provide explicit acceptance criteria or a detailed study report that proves the device meets specific criteria.
The document states that "Clinical: The clinical performance evaluation using the CLOVER A1c™ device was conducted for the purpose of validating the glycosylated hemoglobin and glucose measuring accuracy. Test results showed substantial equivalence." and "Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the CLOVER A1c™ with respect to predicate devices. Pass or fail criteria were based on the specifications cleared for predicate devices and results showed substantial equivalence."
This indicates that a study was performed, but the results and the specific acceptance criteria are not detailed in this summary. The "acceptance criteria" appear to be implicit in demonstrating "substantial equivalence" to the predicate devices, meaning the CLOVER A1c™ performs "as well as" the predicate devices. Without access to the full study report, specific numerical acceptance criteria cannot be extracted.
Therefore, much of the requested information cannot be directly fulfilled from the provided text.
Here is what can be inferred or explicitly stated from the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative acceptance criteria are not provided in the 510(k) summary, a table detailing them cannot be created. The document broadly states that "Test results showed substantial equivalence" for both glycosylated hemoglobin and glucose measuring accuracy, and "Pass or fail criteria were based on the specifications cleared for predicate devices and results showed substantial equivalence."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The summary mentions a "clinical performance evaluation" but does not specify the sample size, country of origin, or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the 510(k) summary. The document does not describe the methodology for establishing ground truth for the clinical performance evaluation.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary. There is no mention of adjudication methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
There is no indication of an MRMC comparative effectiveness study in the provided text. The device is for in vitro diagnostic use, and the performance claims relate to quantitative measurement accuracy, not human reader interpretation of images. Therefore, an MRMC study is unlikely to be relevant or performed for this type of device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
For this type of in vitro diagnostic device (quantitative measurement of A1c and glucose), the "standalone" performance is the primary mode of operation. The device itself performs the measurement. The "clinical performance evaluation" would inherently be a standalone evaluation of the device's accuracy in measuring the target analytes.
7. The Type of Ground Truth Used
The ground truth for devices like this typically involves comparison to a recognized reference method (e.g., HPLC for HbA1c, or a laboratory-grade glucose analyzer calibrated to a standard reference method). While not explicitly stated, the "clinical performance evaluation" would have used a highly accurate and precise method to establish true HbA1c and glucose values in human whole blood samples, against which the CLOVER A1c™ device's measurements were compared. It would likely be analytical measurements from a reference laboratory, not expert consensus or pathology in the sense of imaging.
8. The Sample Size for the Training Set
This information is not provided in the 510(k) summary. As an in vitro diagnostic device that relies on biochemical reactions and photometric/electrochemical measurements, it's less likely to have a "training set" in the machine learning sense, but rather a robust development and validation process using various samples to define its operational parameters.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the 510(k) summary. Similar to point 8, if a "training set" exists (e.g., for calibrating the device or refining algorithms for measurement), the ground truth would have been established using reference methods, but this is not detailed in the summary.
§ 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).