(123 days)
The Hemocue® Hbalc 501 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. Hemocue® Hbalc 501 is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.
The test is for prescription use as an aid in the management of diabetes.
The Hemocue® HbA1c 501 M Glycosylated Hemoglobin test system measures Hemoglobin A 1c in venous and capillary whole blood. The Hemocue® HbA1c 501 ™ Glycosylated Hemoglobin test system includes Analyzer. Test cartridge, Check cartridges(Monthly and Daily), Thermal printer, Barcode scanner, PC cable and fan filter. The Hemocue® HbA1c 501 ™ Glycosylated Hemoglobin test system is a fully automated boronate affinity assay for the determination of the percentage of hemoglobin A1c(HbA1c, %) in human whole blood.
The Test Cartridge consists of a cartridge and a reagent pack containing the reagents necessary for the determination of hemoglobin Alc, with a sampling area for blood collection.
The reagent pack is pre-filled with reagent solution and rinsing solution. The reagent solution contains agents that hemolyse erythrocytes and bind hemoglobin specifically as well as a boronate resin that binds to the cis-diols of glycated hemoglobin.
The blood sample (4uL) is collected at the sampling area of the reagent pack, which is then inserted into the cartridge, where the blood is instantly lysed releasing the hemoglobin and the boronate resin binding the glycated hemoglobin.
The reagent pack containing the blood sample is inserted in Hemocue® HbA1c 501 Analyzer (in which the cartridge has been placed). The cartridge is automatically rotated, placing the blood sample in the measuring zone. The total hemoglobin is photometrically measured by the diffused reflectance of the optical sensor composed of both a LED (Light Emitting Diode) and a PD (Photo Diode). The assembled cartridge is rotated and the rinsing solution washes out non-glycated hemoglobin from the blood sample, enabling photomectical measurement of glycated hemoglobin.
The provided text describes a Special 510(k) submission for the Infopia Co.,Ltd. Glycosylated Hemoglobin (HbA1c) Monitoring System. While it states that "Test results showed substantial equivalence" for clinical performance, it does not provide specific acceptance criteria or detailed results of a study proving the device meets those criteria.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (CLOVER A1c The Glycosylated Hemoglobin Monitoring System, K082275) based on similarities in intended use, operating principle, materials, use environment, shelf life, and calibration method, along with a statement that verification, validation, and testing activities were conducted and passed.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is what can be inferred and what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific quantitative acceptance criteria (e.g., accuracy, precision targets) | Not provided in the text. The text only states that a "clinical performance evaluation" was conducted and "Test results showed substantial equivalence." |
| Predetermined Pass/Fail criteria for non-clinical tests | "The device passed all of the tests based on pre-determined Pass/Fail criteria." (Specific criteria not detailed.) |
| Substantial Equivalence to Predicate Device (CLOVER A1c, K082275) | "The HemoCue® HbA1c501System is as safe, as effective and performs as well as the legally marketed predicate device, CLOVER A1c TM System (K082275)." (This is the overarching conclusion rather than a specific performance metric.) |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The text mentions "clinical performance evaluation" but does not give a sample size.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Method of establishing ground truth: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
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:
- MRMC Study: No, this device is a stand-alone analytical instrument for measuring HbA1c, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC study related to human readers improving with AI is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is an in vitro diagnostic device that quantitatively measures HbA1c. Its performance is its standalone performance. The "clinical performance evaluation" assessed how accurately the device measures HbA1c in blood samples.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not explicitly stated. For HbA1c measurements, the "ground truth" would typically be established by a reference method of HbA1c measurement (e.g., HPLC) recognized as highly accurate, against which the new device's measurements are compared.
8. The sample size for the training set:
- Sample Size (Training Set): Not applicable for this type of medical device which is an in vitro diagnostic instrument for directly measuring a biomarker. The device relies on a chemical/optical detection system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Training Set Ground Truth: Not applicable, as there is no training set for a machine learning model.
In summary: The provided text is a high-level 510(k) summary focusing on substantial equivalence to a predicate device for an HbA1c monitoring system. It does not contain the detailed study results, specific acceptance criteria, or methodological specifics typically found in a full efficacy study report. The key information provided is that a clinical performance evaluation was conducted and deemed "substantially equivalent," and non-clinical tests passed predetermined criteria.
§ 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).