Launch of HbA1c analyzer "Glycohemoglobin Analyzer RC20"
September 29, 2014
Sekisui Medical Co., Ltd.
"Glycohemoglobin Analyzer RC20" (product name: "ラピッドカラム® A1c") will be released on the 29th of September by Sekisui Medical (part of the Sekisui Chemical Group; President: Hideo Tagashira; Head Office: Tokyo, Chuo Ward). Capable of carrying out HbA1c (Hemoglobin A1c) analyses, one of the commonly used tests for diabetes, in 3 minutes using High Performance Liquid Chromatography (HPLC), the analyzer is designed to assist in the diagnosis of diabetes in clinics and small-sized hospitals.
At present in Japan, the number of adults who are suspected to likely be suffering from diabetes is approx. 9.5 million, and this number is on an upwards trend (2012, National Health and Nutrition Survey, March, 2014, Ministry of Health, Labour and Welfare). Early detection and rapid treatment are considered indispensable in both prevention of the disease as well as halting its progress to a more serious condition. It is for this reason that direct patient care facilities, such as specialist diabetes clinics and small-scale hospitals, are feeling an increased need for access to accurate and rapid HbA1c analysis results, allowing them to decide on a treatment path.
In consideration of these needs Sekisui Medical is proud to release our Glycohemoglobin Analyzer RC20 (product name: ラピッドカラム® A1c), an HbA1c Analyzer using the HPLC analytic technique. Analyses can be carried out after setting the specialized column and reagent kit (a cassette containing the eluent) on the device, and obtaining a whole blood sample using the specially-designed sampling device. The analyzer is the realization of careful design for small size and footprint, ideally suited to contribute to the day-to-day operations of facilities responsible for direct patient care, such as clinics and small hospitals.
In addition to this, Sekisui Medical also offers an enzymatic HbA1c reagent, first of its class in Japan, a novel glucose reagent as well as reagents for insulin and other analytes. Sekisui Medical hopes to contribute positively to the diverse field of diabetes diagnosis, answering the various needs of doctor and patient alike.
Product Characteristics
- HPLC based analysis of HbA1c
Capable of carrying out HbA1c analyses, one of the commonly used tests for diabetes, precisely and accurately in 3 minutes using the HPLC analytic technique. - Easy & Rapid Microsample Analyses
3-step, easy operation using a microsample (approx. 3μL of blood either from a fingerstick or blood collection tube) taken with the specially-designed sampling device, with results in 3 minutes. - Small Size & Small Footprint
Small size and small installation footprint approx. the size of an A4 sheet of paper.
Easily installable in the smallest of locations.
Reference Information
- 1Clinical Significance of HbA1c
HbA1c is expressed within red blood cells and is the result of the bonding of the body's oxygen carrying molecule, hemoglobin, and glucose. Also called glycated hemoglobin, the higher the level of blood sugar, the easier glycohemoglobin is formed. Blood sugar levels are constantly fluctuating but HbA1c is stable. As the average life span of a red blood cell, and by extension, hemoglobin, is approximately 4 months, testing HbA1c levels allows for determination of the average blood sugar level of the previous 1 - 2 months.
- 2Product Specifications
| Product name | ラピッドカラム® A1c |
|---|---|
| Brand name | Glycohemoglobin Analyzer RC20 |
| Medical Device Registration Number | 13B2X00163225002 |
| Class | Class I(General medical device requiring specialist maintenance and management) |
| Analyte | Hemoglobin A1c (HbA1c) |
| Analytic technique | HPLC (Cation exchange liquid chromatographic separation analysis) |
| Sample | Whole blood |
| Sample volume | 3μL |
| Analysis time | approx. 3 mins |
| Range | 4.0—15.0% (NGSP) |
| Power supply | AC adapter 100V (50/60Hz) |
| Energy consumption | Max. 52VA |
| External dimensions | W194 x D375 x H364mm |
| Mass | 11.2kg (Excl. AC Adapter) |
- 3Packaging ･ Price
Analyzer Unit
| Part Name | Package Contents | Recommended Retail Price |
|---|---|---|
| Glycohemoglobin Analyzer RC20 | 1 | ¥1,800,000 |
Sold Separately
| Part Name | Package Contents | Recommended Retail Price |
|---|---|---|
| Glycohemoglobin Analyzer RC20 Column | 1 | ¥72,000 |
| Glycohemoglobin Analyzer RC20 Reagent Kit | 1 | ¥32,000 |
| RC20 Sampling Device | 100 | ¥10,000 |
| RC20 Calibrator | Single use x 2 conc. x 1 bottle each | ¥25,000 |
| RC20 Control | Single use x 2 bottles | ¥13,000 |
| RC20 Printer Paper | 10 Rolls | ¥12,000 |
| RC20 External Barcode Reader | 1 | ¥12,000 |
- 4External View:
- Updates to specifications may be made without advance notice.
- "ラピッドカラム®" (RapidColumn as rendered in Japanese) is a trademark owned by Sekisui Medical Co., Ltd. Japan and is registered in Japan and/or other countries.