(33 days)
The Accu-Chek Advantage Module is designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.
The Accu-Chek Advantage Module is an in vitro device designed for measuring the concentration of glucose in whole blood, which is applied to the Accu-Chek Comfort Curve test strips. The test principle is: The enzyme glucose dehydrogenase converts the glucose in a blood sample to gluconolactone. This reaction liberates an electron that reacts with a coenzyme electron acceptor, the oxidized form of the mediator hexacyanoferrate (III), forming the reduced form of the mediator, hexacyanoferrate (II). The test strip employs the electrochemical principle of biamperometry. The meter applies a voltage between two identical electrodes, which causes the reduced mediator formed during the incubation period to be reconverted to an oxidized mediator. This generates a small current that is read by the meter.
The provided text is a 510(k) summary for the Accu-Chek Advantage Module, a device for measuring glucose in whole blood. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance results, study details (like sample size, data provenance, ground truth establishment), or comparative effectiveness studies (MRMC) with human readers.
Therefore, I cannot provide the requested information from the given text. The document is solely a premarket notification summary and does not include the detailed study results that would typically be part of a submission to demonstrate performance.
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K0 21513
JUN 11 2002
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. 1) Submitter Roche Diagnostics Corporation name, address, 9115 Hague Rd. contact Indianapolis, IN 46250 (317) 845-2000 Contact Person: Scott Thiel Date Prepared: May 7, 2002 2) Device name Proprietary name: Accu-Chek Advantage Module Common name: Whole blood glucose test system Classification name: 75 LFR. Glucose dehydrogenase, glucose 3) Predicate We claim substantial equivalence to the Accu-Chek Complete System. device 4) Device The Accu-Chek Advantage Module is an in vitro device designed for Description measuring the concentration of glucose in whole blood, which is applied to the Accu-Chek Comfort Curve test strips. The test principle is: The enzyme glucose dehydrogenase converts the glucose in a blood sample to gluconolactone. This reaction liberates an electron that reacts with a coenzyme electron acceptor, the oxidized form of the mediator hexacyanoferrate (III), forming the reduced form of the mediator, hexacyanoferrate (II). The test strip employs the electrochemical principle of biamperometry. The meter applies a voltage between two identical electrodes, which causes the reduced mediator formed during the incubation period to be reconverted to an oxidized mediator. This generates a small current that is read by the meter.
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510(k) Summary, Continued
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| 5) Intended use | The Accu-Chek Advantage Module is designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities. |
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| 6) Comparison to predicate device | The Roche Diagnostics Accu-Chek Advantage Module is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Accu-Chek Complete System. |
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into the design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service .
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Scott Thiel Regulatory Affairs/Diabetes Specialist Roche Diagnostics Corporation 9115 Hague Rd. P.O. Box 50457 Indianapolis, IN 46250
JUN 1 1 2002
Re: K021513
Device Name: Accu-Chek Advantage Module Regulation Number: 21 CFR$862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: NBW Dated: June 3, 2002 Received: June 5, 2002
Dear Mr. Thiel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): Device Name: Accu-Chek Advantage Module Indications for Use:
The Accu-Chek Advantage Module is designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.
Sean Coogan
(Division Sign-Off)
Division of Clinical Laboratory Devices
Division of Clinical Laboratory Devices
510(k) Number K021513
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.