(80 days)
The Accu-Chek Advantage and Accu-Chek Advantage H Test Strips are to be used with the Accu-Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu-Chek Advantage and Accu-Chek Complete monitors are designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.
Professionals may use the test strips to test capillary, venous, arterial and neonate (including cord) blood samples; lay use is limited to capillary blood testing.
The Accu-Chek Advantage and Accu-Chek Advantage H Test Strips are to be used with the Accu-Chek® Advantage® and Accu-Chek® Complete™ Monitors. The test strips are designed for convenient, confident, and accurate testing of blood glucose in whole blood samples.
The provided text is a 510(k) summary for the Accu-Chek Advantage and Accu-Chek Advantage H Test Strips. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through a clinical trial with acceptance criteria for a new device.
Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria in the way a traditional clinical trial report would.
Here's why the requested information cannot be extracted from this document:
- 510(k) Submissions Focus on Substantial Equivalence: The primary goal of a 510(k) is to convince the FDA that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves demonstrating similar technological characteristics and intended use, and that any differences do not raise new questions of safety or effectiveness. It's not typically a full-scale clinical trial proving efficacy against pre-defined performance metrics for a novel technology.
- Lack of Performance Data: While the document mentions the device is "designed for convenient, confident, and accurate testing," it does not provide any specific numerical performance data (e.g., accuracy, precision, sensitivity, specificity, or bias) that would be compared against acceptance criteria.
- No Mention of Study Design: There is no description of a study design, sample sizes, ground truth establishment, or expert adjudication as would be found in a clinical study report. The closest it comes to a "study" is the explanation of changing the reference curve to reflect plasma glucose values, but no data from this modification is presented.
Based on the provided text, I cannot complete the table or answer the questions as the information is not present.
The document states:
- "The modified Boehringer Mannheim Accu-Chek Advantage and Accu-Chek Advantage H Test Strips are substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Accu-Chek Advantage Test Strip (K951887 and K954833)."
- "Boehringer Mannheim has modified the reference curve employed within the code key used with the Accu-Chek Advantage and Accu-Chek Advantage H test strips to now provide results which reflect the higher laboratory plasma glucose value."
This indicates a modification to an existing device (the "predicate device") to report plasma equivalent glucose values instead of whole blood equivalent values. The substantial equivalence argument relies on the predicate device's existing clearance and the technical justification for the change, not on a new, comprehensive clinical performance study with explicit acceptance criteria provided in this summary.
To get the requested information, one would need to consult the original 510(k) submissions for the predicate devices (K951887 and K954833) or a more detailed technical report for the Accu-Chek Advantage and Accu-Chek Advantage H Test Strips, which is not included in this extract.
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Accu-Chek Advantage and Accu-Chek Advantage H Test Strips
510(k) Summary
| 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 | Boehringer Mannheim Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000 |
| Contact Person: | Mike Flis |
| Date Prepared: | June 5, 1998 |
| 2) Device name | Proprietary name: Accu-Chek™ Advantage® and Accu-Chek™ Advantage H™ Test StripsCommon name: Blood glucose test systemClassification name: glucose dehydrogenase, glucose |
| 3) Predicate device | We claim substantial equivalence to the unmodified Accu-Chek Advantage Test Strip. |
| 4) Device Description | The Accu-Chek Advantage and Accu-Chek Advantage H Test Strips are to be used with the Accu-Chek® Advantage® and Accu-Chek® Complete™ Monitors. The test strips are designed for convenient, confident, and accurate testing of blood glucose in whole blood samples. |
Continued on next page
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510(k) Summary, Continued
| 5) Intended use | The Accu-Chek Advantage and Accu-Chek Advantage H Test Strips are to beused with the Accu-Chek® Advantage® and Accu-Chek® Complete™Monitors. The Accu-Chek Advantage and Accu-Chek Complete monitors aredesigned for testing glucose in whole blood by persons with diabetes or byhealth care professionals in the home or in health care facilities.Professionals may use the test strips to test capillary, venous, arterial andneonate (including cord) blood samples; lay use is limited to capillary bloodtesting. |
|---|---|
| 6) Comparisonto predicatedevice | The modified Boehringer Mannheim Accu-Chek Advantage and Accu-ChekAdvantage H Test Strips are substantially equivalent to other products incommercial distribution intended for similar use. Most notably it issubstantially equivalent to the currently marketed Accu-Chek Advantage TestStrip (K951887 and K954833). |
| Blood glucose concentrations can be expressed two ways, as whole bloodglucose or as plasma (or serum) glucose. The concentration of glucose inwhole blood is lower (by about 8%) than the plasma glucose value for thissame blood sample because of the differences in distribution of water betweenthe two compartments (red blood cells and plasma). Test strips developed forthe measurement of whole blood samples were traditionally referenced toprovide a whole blood glucose value. However, many North Americanlaboratories have, for the last few decades, routinely measured and reportedonly the plasma glucose values. Recent advancements in the management ofpatients with diabetes have created a preference to have the results for bloodglucose test strips reflect the laboratory plasma value instead of the moretraditional whole blood value. For this reason Boehringer Mannheim hasmodified the reference curve employed within the code key used with theAccu-Chek Advantage and Accu-Chek Advantage H test strips to nowprovide results which reflect the higher laboratory plasma glucose value. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 3 1998
Mike Flis . Requlatory Affairs Specialist Boehringer Mannheim 9115 Hague Road P.O. Box 50457 46250-0457 Indianapolis, Indiana
K982089 Re : Accu-Chek® Advantage™ and Advantage H™ Test Strips Requlatory Class: II Product Code: LFR Dated: June 11, 1998 Received: June 15, 1998
Dear Mr. Flis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice; labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major ---regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 entification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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® and Accu-Chek™ Advantage H™ Test Strips Indications for Use:
The Accu-Chek Advantage and Accu-Chek Advantage H Test Strips are to be used with the Accu-Chek® Advantage® and Accu-Chek® Complete™ Monitors. The Accu-Chek Advantage and Accu-Chek Complete monitors are designed for testing glucose in whole blood by persons with diabetes or by health care professionals in the home or in health care facilities.
Professionals may use the test strips to test capillary, venous, arterial and neonate (including cord) blood samples; lay use is limited to capillary blood testing.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K982084
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.