(131 days)
The G7 Automated HPLC Analyzer is a high pressure liquid chromatography system intended for IN VITRO DIAGNOSTIC USE ONLY. Glycosylated system intended for wents obtained by this device are used in the management and treatment of diabetes.
The G7 Automated HPLC Analyzer: HbA1c Variant Analysis Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports stable A1c (SA1c) percentage in whole blood. The operational portion of the HPLC G7 is composed of a sampling unit, liquid pump, degasser, column, detector, microprocessors, sample loader, floppy disk drive unit, operation panel and a printer.
The G7 uses a cation exchange column and separates the usual hemoglobin components in the blood into six fractions, A1a, A1b, F, L-A1c, SA1c and A0. The separation is done by eluting the hemoglobins from the column with a gradient of three elution buffers containing different salt concentrations. The result report is printed out from the on-board printer and can be stored on a floppy disk from the on-board floppy disk drive. The data can be transmitted to a host computer. The result report includes a sample ID, date, percentage and retention time of each fraction, SA1c percentage and total A1 percentage (A1a + A1b + SA1c) along with a chromatogram of the elution pattern of the hemoglobin fractions. If a sample contains a hemoglobin variant, the column elutes the material depending upon its charge. The software compares the retention times to "known windows" and designates the material as P0X or H-VX if it does not match a defined window.
All automated processes in the G7 are controlled by internal microprocessors, using software downloaded via the on-board floppy disk drive.
This summary describes the Tosoh G7 Automated HPLC Analyzer in its HbA1c Variant Analysis Mode.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" with numerical thresholds. Instead, it demonstrates substantial equivalence to a predicate device (Tosoh A1c 2.2 Plus) by showing high correlation and precision. Therefore, the "acceptance criteria" are implied by the comparison to the predicate device and satisfactory statistical results.
| Metric | Implied Acceptance Criteria (via Predicate Comparison) | Reported Device Performance (G7 Automated HPLC Analyzer) |
|---|---|---|
| Comparative Analysis | Highly correlated with Tosoh A1c 2.2 Plus | |
| Slope | Close to 1.0 | 1.001 |
| Intercept | Close to 0.0 | -0.12 |
| Correlation Coefficient | Close to 1.0 | 0.9987 |
| Range of Samples (%) | Comparable to predicate's operating range | 3.4 - 15.9 |
| Precision | Low %CVs | |
| Intra-run precision %CVs | Not explicitly stated for predicate; generally low | 0.9% or less |
| Inter-run precision %CVs | Not explicitly stated for predicate; generally low | 1.6% or less |
| Total precision (mean 5.79% HbA1c) | Not explicitly stated for predicate; generally low | 1.12% |
| Total precision (mean 10.90% HbA1c) | Not explicitly stated for predicate; generally low | 0.71% |
| Recovery Studies | Close to 100% | 100% to 102% |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 230 patient samples
- Data Provenance: The document states "patient samples obtained from 230 patients." This implies clinical samples, likely from a patient population relevant to diabetes management. Given that the manufacturer is Tosoh Medics, Inc. based in South San Francisco, California, the data is likely from the United States, and it is almost certainly retrospective as samples were "obtained" and then assayed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of consensus readings. Instead, the "ground truth" for the comparative analysis is implicitly the results obtained from the predicate device, the Tosoh A1c 2.2 Plus Automated Glycohemoglobin Analyzer. The study aims to show equivalence between the new device and the existing, cleared device, rather than establishing a completely independent ground truth.
4. Adjudication Method for the Test Set:
Not applicable. There was no expert "adjudication" in the traditional sense. The comparison was statistical against the predicate device's results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is for an automated in vitro diagnostic device, not an imaging device requiring human interpretation, so MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the study described is a standalone performance assessment of the G7 Automated HPLC Analyzer. It evaluates the device's analytical performance (comparative analysis, precision, recovery) in producing HbA1c results, without human interpretation of the chromatograms being the primary endpoint for clinical decision-making within the study design. The device is fully automated.
7. The Type of Ground Truth Used:
The "ground truth" for the performance evaluation was the results obtained from the predicate device (Tosoh A1c 2.2 Plus Automated Glycohemoglobin Analyzer). The study's objective was to demonstrate substantial equivalence to this already cleared device.
8. The Sample Size for the Training Set:
The document does not specify a separate "training set" or its sample size. For an IVD device like this, the development and training (calibration, algorithm optimization) would likely be an internal process before the equivalence study. The "230 patient samples" refer to the test set used for demonstrating substantial equivalence.
9. How the Ground Truth for the Training Set Was Established:
Not specified. As mentioned above, a separate training set is not explicitly detailed. The device likely uses internal calibration methods which would be established during development, rather than a "ground truth" for a machine learning training process described in the document. The device's operation relies on established HPLC principles and a "cation exchange column" with "three elution buffers." The software compares retention times to "known windows," implying pre-defined chemical properties rather than data-driven machine learning ground truth establishment.
§ 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).