G8 Automated HPLC Analyzer Model HLC-723 G8
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K071132 FDA 510(k)
- FDA Product Code
- LCP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7470 FDA 510(k)
- Regulation Number
- 864.7470 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The G8 Automated HPLC Analyzer Model HLC-723 G8 is an automated high-performance liquid chromatography (HPLC) system designed for the quantitative measurement of glycosylated hemoglobin (HbA1c) in venous whole blood specimens. It employs the gold-standard ion-exchange method to differentiate and analyze HbA1c levels, providing results in both percentage (%HbA1c, DCCT/NGSP) and mmol/mol (IFCC) units. This device is classified under assay devices for hematology applications and is intended for in vitro diagnostic use.
The G8 HPLC Analyzer is supplied as a reusable laboratory instrument and is intended for use in clinical or laboratory settings. It features a low coefficient of variation (CV) of less than 2% and delivers analysis results in approximately 1.6 minutes per sample, supporting high-throughput testing. The device is regulated under FDA 510(k) clearance (K071132) and falls under device class II (regulation number 864.7470). It is not specified as MRI-safe or single-use, and storage conditions are not detailed in the provided data.
Frequently asked questions
What clinical measurement does the G8 Automated HPLC Analyzer primarily perform, and how does it compare to other methods?
The G8 Automated HPLC Analyzer is designed for the quantitative measurement of glycosylated hemoglobin (HbA1c) in venous whole blood specimens using the gold-standard ion-exchange HPLC method. This method differentiates and analyzes HbA1c levels with high precision, providing results in both percentage (%HbA1c, DCCT/NGSP) and mmol/mol (IFCC) units. The ion-exchange method is widely regarded as the most accurate for HbA1c testing, offering superior specificity compared to alternative techniques like immunoassays or turbidimetric inhibition assays.
How fast and reliable are the results produced by the G8 HPLC Analyzer, and what throughput can it support?
The G8 HPLC Analyzer delivers analysis results in approximately 1.6 minutes per sample, enabling high-throughput testing in clinical or laboratory settings. Its low coefficient of variation (CV) of less than 2% ensures high reliability and consistency for HbA1c measurements, making it suitable for busy environments where rapid and accurate results are critical.
Is the G8 HPLC Analyzer reusable, and if so, what maintenance or consumables are required for its operation?
Yes, the G8 HPLC Analyzer is a reusable laboratory instrument, meaning it is designed for long-term use in clinical or laboratory settings. While the device itself is not single-use, it requires specific consumables (such as blood collection tubes, reagents, and disposable sample vials) for each analysis. The manufacturer’s instructions should be followed for proper maintenance, calibration, and upkeep to ensure continued accuracy and performance.
What regulatory pathway was followed for the G8 HPLC Analyzer, and what classification does it hold?
The G8 Automated HPLC Analyzer received FDA 510(k) clearance (K071132) under the traditional review pathway, demonstrating that it is substantially equivalent to a legally marketed predicate device. It is classified under FDA device class II (regulation number 864.7470) and is intended for in vitro diagnostic use in hematology applications. This classification reflects its role as an assay device for measuring HbA1c in venous whole blood.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: G8 Analyzer | https://www.diagnostics.eu.tosohbioscience.com/, G8 HPLC Analyzer - Tosoh, HLC-723G8 | Tosoh Bioscience, HLC-723G8 | Tosoh Bioscience, Overview | Tosoh G8 HPLC Analyzer
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K071132 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tosoh Bioscience, Inc.
Sources (1)
- FDA 510(k) K071132 24 fields · synced Sep 20, 2026