(24 days)
We claim substantial equivalence to the current legally marketed Accu-Chek Advantage System.
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No
The summary describes a standard glucose meter based on amperometric and glucose dehydrogenase principles, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
No
The device is designed to measure glucose levels, not to treat a condition. It provides diagnostic information rather than therapy.
Yes
The device "quantitatively measure[s] the concentration of glucose in capillary whole blood," which is used as a diagnostic indicator for diabetes.
No
The device description explicitly mentions an "Instrument Operating Principle" (amperometric) and a "Reagent Test Principle" (glucose dehydrogenase), indicating the use of physical hardware and chemical reagents to perform the glucose measurement. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed to "quantitatively measure the concentration of glucose in capillary whole blood". This is a measurement performed in vitro (outside the body) on a biological sample (blood).
- Sample Type: It uses "capillary whole blood", "venous, arterial, and neonate (including cord) blood samples". These are all biological samples.
- Measurement Principle: It uses "amperometric" and "glucose dehydrogenase" principles, which are common methods for analyzing biological samples in a laboratory or point-of-care setting.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that description by measuring glucose in blood samples to provide information for persons with diabetes or healthcare professionals.
N/A
Intended Use / Indications for Use
The Accu-Chek Advantage system is designed to quantitatively measure the concentration of glucose in capillary whole blood. The device is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary, venous, arterial, and neonate (including cord) blood samples; lay use is limited to capillary whole blood testing.
The Accu-Chek Advantage system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale.
Professionals may use the test strips to test capillary, venous, arterial, and neonate (including cord) blood samples; lay use is limited to capillary whole blood testing.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
Instrument Operating Principle -- amperometric
Reagent Test Principle -- glucose dehydrogenase
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
professional use and over-the-counter sale.
Professionals may use the test strips to test capillary, venous, arterial, and neonate (including cord) blood samples; lay use is limited to capillary whole blood testing.
by persons with diabetes or by health care professionals in the home or in health care facilities.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing on the modified Accu-Chek Advantage (modified) System demonstrated that the device meets the performance requirements for its intended use. All predetermined acceptance criteria were satisfied. The data demonstrates that the Accu-Chek Advantage is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
We claim substantial equivalence to the current legally marketed Accu-Chek Advantage System.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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SEP 1 2 2003
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| 510(k) Summary | K032552 |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
| 1) Submitter name, address, contact | Roche Diagnostics Corporation |
| 9115 Hague Rd. | |
| Indianapolis, IN 46250 | |
| (317) 845-2000 | |
| Contact Person: Scott Thiel | |
| Date Prepared: August 18, 2003 | |
| 2) Device name | Proprietary name: Accu-Chek Advantage System |
| Classification name: Glucose dehydrogenase, glucose test system | |
| (21 C.F.R. § 862.1345)(75LFR) | |
| 3) Predicate device | We claim substantial equivalence to the current legally marketed Accu-Chek Advantage System. |
| 4) Device Description | Instrument Operating Principle -- amperometric |
| Reagent Test Principle -- glucose dehydrogenase | |
| 5) Intended use | The Accu-Chek Advantage system is designed to quantitatively measure the concentration of glucose in capillary whole blood. The device is indicated for professional use and over-the-counter sale. Professionals may use the test strips to test capillary, venous, arterial, and neonate (including cord) blood samples; lay use is limited to capillary whole blood testing. |
| Feature/Claim | Detail |
| Intended use | The Accu-Chek Advantage system is designed to quantitatively measure the |
| concentration of glucose in capillary whole blood. The device is indicated for | |
| professional use and over-the-counter sale. Professionals may use the test | |
| strips to test capillary, venous, arterial, and neonate (including cord) blood | |
| samples; lay use is limited to capillary whole blood testing. | |
| Test principle | 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. | |
| Monitor coding | Code chip is provided with each carton of test strips. |
| procedure | |
| Test strip storage | Store at room temperature between +36° F (+2° C) and +86° F (+30° C). |
| conditions | |
| Test strip operating | Between +5° F (+10° C) and +104° F (+40° C). |
| conditions | |
| Quality control | Tests should be run with liquid quality control materials whenever a new vial |
| of test strips is opened or an unusual blood test result is obtained. | |
| testing frequency | |
| Quality control | The mean is strip lot specific and will be determined individually. The range |
| of the controls is within ± 15 mg/dL or ± 15% compared to the determined | |
| mean. | |
| acceptable range | |
| Labeling instructions | The normal fasting adult blood glucose range for a non-diabetic is 70-105 |
| mg/dL. One to two hours after meals, normal blood glucose levels should be | |
| less than 140 mg/dL. Doctors will determine the range that is appropriate for | |
| the patients. | |
| regarding expected | |
| results | |
| Labeling instructions | Run a quality control test, if the result is outside the acceptable QC recovery |
| range contact Roche Diagnostics's Accu-Chek Customer Care center; if | |
| result is within the acceptable range, review proper testing procedure and | |
| repeat blood glucose test with a new test strip. | |
| regarding response | |
| to unusual results |
:
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510(k) Summary, Continued
The Roche Diagnostics Accu-Chek Advantage (modified) System is 6) Similarities substantially equivalent to the current legally marketed Accu-Chek Advantage (predicate) System. The proposed modification is relatively modest in scope. The following is a list of some of the claims and features unaffected by the proposed modification.
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Continued on next page
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510(k) Summary, Continued
6) Similarities (continued)
| Feature/Claim | Detail |
|---|---|
| Acceptable sample | |
| types | Capillary whole blood samples from a fingerstick. Venous, neonatal, or arterial blood may also be used only if drawn by health care professionals. |
| Reportable range | 10-600 mg/dL |
| Hematocrit range | 20 - 65 % in vitro diagnostic use only. |
7) Data demonstrating substantial equivalence
Performance testing on the modified Accu-Chek Advantage (modified) System demonstrated that the device meets the performance requirements for its intended use. All predetermined acceptance criteria were satisfied. The data demonstrates that the Accu-Chek Advantage is substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched, with three wavy lines emanating from the eagle's body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road Rockville MD 20850
Mr. Scott Thiel Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K032552
Trade/Device Name: Accu-Chek Advantage Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: August 18, 2003 Received: August 19, 2003
SEP 1 2 2003
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): Қозасы (1): Қозаст 2) Device Name: Accu-Chek Advantage Test System
Indications for Use:
The Accu-Chek Advantage system is designed to quantitatively measure the concentration of qlucose in capillary whole blood by persons with diabetes or by health care professionals in the home or in health care facilities. The device is indicated for professional use and overthe-counter sale.
Professionals may use the test strips to test capillary, venous, arterial, and neonate (including cord) blood samples; lay use is limited to capillary whole blood testing.
(Please DO Not WRITE BÈLOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Carol C Benam/s Jean Cooper, DVM
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K 032552
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)