(91 days)
The Bio-Rad VARIANT™ II TURBO Link Hemoglobin A1c Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high performance liquid chromatography (HPLC).
The VARIANT II TURBO Link Hemoglobin A1c Program is for use with the VARIANT II TURBO Link Hemoglobin Testing System interfaced with an automated sample transport system.
The Bio-Rad VARIANT II TURBO Link Hemoglobin A1c Program is for Professional Use Only.
Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
The VARIANT II TURBO Link Hemoglobin Testing System uses the principles of high performance liquid chromatography (HPLC). The VARIANT II TURBO Link Hemoglobin A lc Program is based on chromatographic separation of Hemoglobin Alc on a cation exchange cartridge. The reagents in the VARIANT II TURBO Link Hemoglobin A 1c Program have the same formulation as the reagents in the VARIANT II TURBO Hemoglobin A1c Program.
Here's a breakdown of the acceptance criteria and study details for the Bio-Rad VARIANT™ II TURBO Link Hemoglobin A1c Program, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the comparison to the predicate device. The study aims to demonstrate substantial equivalence by showing similar performance.
| Performance Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (VARIANT™ II TURBO Link) |
|---|---|---|
| Accuracy | Similar regression analysis to predicate | R² = 0.998, Slope = 0.983, Intercept = 0.225 |
| Precision | Equivalent within-run and total precision | Normal: Within run %CV = 0.62, Total %CV = 1.27 |
| Diabetic: Within run %CV = 0.47, Total %CV = 0.92 | ||
| Linearity | Similar linear range | 4.1 – 17.6 % HbA1c |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 180 EDTA whole blood patient samples for accuracy, and 80 normal and 80 diabetic patient samples for precision.
- Data Provenance: Not explicitly stated, but given the context of a 510(k) submission for a US market, it's highly probable the data was collected in the US. The document does not specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For HbA1c measurements, the "ground truth" is typically the reference method itself (HPLC in this case, specifically traced to DCCT and IFCC, and certified by NGSP), rather than expert consensus on individual samples. The study compares the new device's measurements to those of the predicate device (which is also traceable to these standards).
4. Adjudication Method for the Test Set
This information is not applicable as the ground truth is established by a quantitative analytical method (HPLC traceable to standards), not by human interpretation requiring adjudication.
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
This question is not applicable. This is a submission for an in vitro diagnostic device (analyzing blood samples) and not an imaging or AI-assisted diagnostic tool that would involve human "readers" or AI assistance in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This device operates as a standalone analytical instrument. The reported performance metrics (accuracy, precision, linearity) are reflective of its standalone performance without human input influencing the measurement itself, beyond standard laboratory procedures for sample handling and instrument operation. The "algorithm" here refers to the underlying HPLC and data processing, which operate automatically.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the device's performance is established by:
- Traceability to recognized reference methods: Diabetes Control and Complications Trial (DCCT) reference method and IFCC.
- Certification: via the National Glycohemoglobin Standardization Program (NGSP).
- Comparison to a legally marketed predicate device: The VARIANT II TURBO Hemoglobin A1c Program (K040872 and K063400), which itself would adhere to these traceability and certification standards.
Essentially, the ground truth is anchored by widely accepted analytical reference standards for HbA1c measurement.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This is a regulatory submission for a diagnostic instrument, not a machine learning model that undergoes "training." The device's performance is validated through accuracy, precision, and linearity studies directly comparing it to a predicate and reference standards, rather than by training on a dataset.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8.
§ 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).