(512 days)
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for IN VITRO DIAGNOSTIC USE for the measurement of hemoglobin A1c (HbA1c) in whole blood specimens. Hemoglobin A1c measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control.
The Hemoglobin A1c Calibrator Set is a reference agent designed for calibrating the Tosoh Automated Glycohemoglobin Analyzer HLC-723G8.
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (G8) is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports stable Alc (sAlc) percentage in whole blood. The operational portion of the G8 is composed of a sampling unit, liquid pump, degasser, column, detector, microprocessors. sample loader, floppy disk drive unit, operation panel, and a printer.
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 uses non-porous ionexchange high performance liquid chromatography (HPLC) for rapid, accurate and precise separation of the stable form of HbA1c from other hemoglobin fractions. The G8 uses a cation exchange column and separates the usual hemoglobin components in the blood into six fractions, Ala, A1b, F, L-A1c, sA1c, and A0. The separation is done by eluting the hemoglobins from the column with a stepwise elution of three elution buffers containing different salt concentrations. The result report is printed out and can be stored on a digital media. 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 calibrator set consists of two levels of calibrator, the low level in the non-diabetic range and the high level in the diabetic range. These two calibrators are used to establish a reference curve from which to establish the percentage of HbA1c in patient and control samples.
Here's a breakdown of the acceptance criteria and the study details for the Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin A1c Calibrator Set, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Difference between device and predicate to be within allowable error range | 100% of 114 specimens (HbA1c range 4.0-16.8%) showed differences within ±0.5% compared to the predicate device. |
| Functioning as intended, with expected A1c and Total HbA measurements | "In all instances, the Automated Glycohemoglobin Analyzer HLC-723G8 and Hemoglobin A1c Calibrator Set functioned as intended and measurement of A1c and Total HbA was as expected." |
Note: The document does not explicitly state numerical acceptance criteria for precision, linearity, or other specific performance aspects beyond the method comparison. The "allowable error range" for the method comparison is defined as ±0.5%.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 114 specimens
- Data Provenance: Not explicitly stated (e.g., country of origin). The study compared the new device against a predicate device. It is presented as a singular comparison study to demonstrate substantial equivalence, implying it was a retrospective analysis of samples rather than a prospective trial with new patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for the test set was established by the predicate device's measurements, not by expert consensus. The study focused on comparing the new device's measurements against these established values.
4. Adjudication Method for the Test Set
Not applicable. There was no mention of an adjudication process as the comparison was made against a single predicate device's output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study detailed is a method comparison study between a new automated analyzer and a predicate automated analyzer, not an evaluation of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The entire study describes the performance of the automated analyzer (algorithm/instrument only) in measuring HbA1c, without any human intervention in the measurement process beyond sample loading.
7. The Type of Ground Truth Used
The ground truth used for the method comparison was the measurements obtained from the predicate device, Tosoh Bioscience, Inc.'s G7 Automated HPLC Analyzer (K011434).
8. The Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its size. This is typical for a device like an automated analyzer, where performance is validated through analytical studies (precision, linearity, method comparison) rather than machine learning model training. The calibrators are used for establishing the reference curve within the device's operational setup, but this isn't a "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a "training set" in the AI/ML sense is not described. For the instrument's operation, the "ground truth" (or reference) for its internal calibration is established using a two-level Hemoglobin A1c Calibrator Set, with the low level in the non-diabetic range and the high level in the diabetic range. These calibrators establish a reference curve for the instrument.
§ 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).