(24 days)
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 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.
Instrument Operating Principle -- amperometric
Reagent Test Principle -- glucose dehydrogenase
The provided text indicates that the Accu-Chek Advantage (modified) System underwent performance testing to demonstrate its substantial equivalence to the predicate device. However, the document does not contain a table of specific acceptance criteria or detailed results of the device's performance against those criteria. It only states that "All predetermined acceptance criteria were satisfied."
Here's an analysis of the provided information related to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states: "All predetermined acceptance criteria were satisfied." However, the specific acceptance criteria and the detailed performance results are not listed.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text. The document mentions "Performance testing" but does not specify the sample size used for the test set or the provenance (e.g., country of origin, retrospective/prospective nature) of the data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable/Not available. For glucose measurement devices, the "ground truth" is typically established through reference laboratory methods (e.g., YSI analyzer) rather than expert consensus on images or clinical assessments. The document does not provide details on how ground truth was established, but it is highly unlikely to involve human experts for this type of device.
4. Adjudication Method for the Test Set
Not applicable/Not available. Since the ground truth for glucose measurement is established by laboratory methods, an adjudication method for expert consensus is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not relevant for a glucose measurement device. MRMC studies are typically used to assess the performance of diagnostic imaging aids where human readers interpret medical images.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes (implicitly). The "Performance testing on the modified Accu-Chek Advantage (modified) System" implies standalone performance, as a glucose meter directly measures glucose levels and does not involve a human interpretation loop in the same way an AI for image analysis would. The device's performance is its output.
7. The Type of Ground Truth Used
Implicitly, a reference laboratory method. For glucose meters, the ground truth for "quantitatively measure the concentration of glucose" is established by comparing the device's readings to those obtained by a highly accurate and precise reference laboratory method (e.g., a YSI glucose analyzer). This is a well-established practice in the in vitro diagnostics industry, though not explicitly stated in this summary.
8. The Sample Size for the Training Set
Not applicable/Not available. This device is an electrochemical glucose meter. There is no mention of a "training set" as would be used for machine learning algorithms. The device's performance is based on its chemical and electrical design, not on a machine learning model trained on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available. As mentioned above, there is no "training set" in the context of this device.
Summary of what is available from the provided text:
- Acceptance Criteria & Performance: Stated that "All predetermined acceptance criteria were satisfied," but no details are provided.
- Study Type: Performance testing was conducted to demonstrate substantial equivalence to the predicate device.
- Comparison: The modified device was deemed "substantially equivalent" to the current legally marketed Accu-Chek Advantage System.
- Intended Use: Quantitatively measure the concentration of glucose in capillary whole blood.
- Measuring Principle: Amperometric, using glucose dehydrogenase.
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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 Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000Contact Person: Scott ThielDate Prepared: August 18, 2003 |
| 2) Device name | Proprietary name: Accu-Chek Advantage SystemClassification 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 -- amperometricReagent 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 theconcentration of glucose in capillary whole blood. The device is indicated forprofessional use and over-the-counter sale. Professionals may use the teststrips to test capillary, venous, arterial, and neonate (including cord) bloodsamples; lay use is limited to capillary whole blood testing. |
| Test principle | The enzyme glucose dehydrogenase converts the glucose in a blood sampleto gluconolactone. This reaction liberates an electron that reacts with acoenzyme 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 ofbiamperometry. The meter applies a voltage between two identicalelectrodes, which causes the reduced mediator formed during the incubationperiod to be reconverted to an oxidized mediator. This generates a smallcurrent 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 vialof 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 rangeof the controls is within ± 15 mg/dL or ± 15% compared to the determinedmean. |
| acceptable range | |
| Labeling instructions | The normal fasting adult blood glucose range for a non-diabetic is 70-105mg/dL. One to two hours after meals, normal blood glucose levels should beless than 140 mg/dL. Doctors will determine the range that is appropriate forthe patients. |
| regarding expectedresults | |
| Labeling instructions | Run a quality control test, if the result is outside the acceptable QC recoveryrange contact Roche Diagnostics's Accu-Chek Customer Care center; ifresult is within the acceptable range, review proper testing procedure andrepeat blood glucose test with a new test strip. |
| regarding responseto 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 sampletypes | 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 % < 200 mg/dl and 20 - 55% ≥ 200 mg/dl |
| Warnings andprecautions | For 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)
§ 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.