(156 days)
The ACCU-CHEK Aviva Test Strips are used with the ACCU-CHEK Aviva meter. The ACCU-CHEK Aviva test system is designed to quantitatively measure the concentration of glucose for monitoring glucose in the home or in health care facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.
Professionals may use the test strips to test capillary, venous, arterial, and neonatal blood; home use is limited to capillary whole blood testing.
The ACCU-CHEK Aviva Test Strips are stored within a desiccated vial. A test strip is removed from the vial and inserted into the meter. Upon insertion, the meter is activated. Blood is applied to the end of the test strip, and a glucose result is reported.
The test principle is: Blood from the test site works with the chemicals in the test strip to make a small electrical current in the test strip. The meter reads the current and gives a blood glucose results.
The provided text is a 510(k) Summary for ACCU-CHEK® Aviva Test Strips. This document primarily focuses on demonstrating substantial equivalence to a predicate device and obtaining FDA clearance for marketing. It does not contain a detailed study report with acceptance criteria and specific performance data in the format requested.
The document discusses the intended use, device description, and similarities/differences to the predicate device, but it lacks the specific study details (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established) that would typically be found in a comprehensive performance study report.
Therefore, I cannot fully complete the requested table and sections based on the provided text. I will extract the information that is present and note where data is missing.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided 510(k) summary. Acceptance criteria for device performance (e.g., accuracy percentages, bias) are typically established for a clinical study and then compared against the device's measured performance. This document does not present such a table.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not present in the provided 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not present in the provided 510(k) summary. For glucose meters, ground truth is typically established by laboratory reference methods, not expert consensus in the same way it would be for imaging devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the provided 510(k) summary. Adjudication is not typically applicable for objective measurements like glucose levels.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not present and is not applicable to this device. An MRMC study is relevant for AI-powered diagnostic tools where human readers interpret images or data, with and without AI assistance. This device is a standalone glucose measurement system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device described, ACCU-CHEK® Aviva Test Strips with the Aviva meter, is a standalone glucose measurement system. Its performance is inherent to the device itself and its interaction with a blood sample. A "standalone" study in the AI context refers to the algorithm's performance without human input, which could be considered analogous to the meter's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
While not explicitly stated in the provided text, for a glucose measurement device, the "ground truth" would typically be established by a laboratory reference method for glucose measurement (e.g., YSI analyzer, hexokinase method). The 510(k) summary does not specify this, but it is standard practice for such devices.
8. The sample size for the training set:
This information is not present in the provided 510(k) summary. This device is a traditional electrochemical sensor, not an AI/ML-based device that would require explicit "training data" in the same sense as an algorithm. Any "training" would be part of the R&D and calibration processes, not a distinct dataset for an algorithm.
9. How the ground truth for the training set was established:
This information is not present and is not applicable in the AI/ML sense of a "training set" for the reasons mentioned above.
Summary of available information:
The provided document is a 510(k) summary, which is a premarket notification to FDA. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting detailed performance study results with specific acceptance criteria and the comprehensive study design requested.
Key information from the document related to performance/description:
- Intended Use: Quantitatively measure glucose in capillary, venous, arterial, and neonate samples (professional use); capillary whole blood (home use). For monitoring glucose in home or healthcare facilities.
- Reportable Range: 10 - 600 mg/dL
- Test Sample Volume: 0.6 µL
- Test Time: 5 seconds
- Hematocrit Range: 10 - 70% (Difference from predicate, which was 20-70%)
Without a separate, detailed performance study report, the specific questions regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment (beyond the general understanding for a glucose meter) cannot be answered from this 510(k) summary.
{0}------------------------------------------------
AUG 1 1 2006
| 510(k) Summary | AUG 11 2006 | |
|---|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. | |
| 1) Submittername, address,contact | Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46256(317) 521-2000 | |
| Contact Person: Scott Thiel / Luann Ochs | ||
| Date Prepared: August 3, 2006 | ||
| 2) Device name | Proprietary name: ACCU-CHEK® Aviva Test Strips | |
| Common name: Whole blood glucose test system | ||
| Classification name: 75, LFR, Glucose Dehydrogenase, glucose | ||
| 3) Predicatedevice | The Roche Diagnostics ACCU-CHEK Aviva system cleared under K043474on April 27, 2005. | |
| 4) DeviceDescription | The ACCU-CHEK Aviva Test Strips are stored within a desiccated vial. Atest strip is removed from the vial and inserted into the meter. Uponinsertion, the meter is activated. Blood is applied to the end of the test strip,and a glucose result is reported. | |
| The test principle is: | ||
| Blood from the test site works with the chemicals in the test strip to make asmall electrical current in the test strip. The meter reads the current and givesa blood glucose results. |
Continued on next page
{1}------------------------------------------------
The ACCU-CHEK Aviva Test Strips are used with the ACCU-CHEK Aviva 5) Intended use meter. The ACCU-CHEK Aviva system is designed to quantitatively measure the concentration of glucose for monitoring glucose in the home or in health care facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.
Professionals may use the test strips to test capillary, venous, arterial, and neonate samples; home use is limited to capillary whole blood testing.
The proposed modification is relatively modest in scope. The following is a 6) Similarities to predicate list of some of the claims and features unaffected by the proposed device modifications.
| Feature/Claim | Detail |
|---|---|
| Intended Use | Both systems are intended for testing glucose in whole blood bypersons with diabetes or by health care professionals in the home or inhealth care facilities. |
| Closed System | Each system's test strips and controls are designed to be used only withthat system. |
| Test Principle | Chemicals in the test strip make a small electric current in the test stripwhen dosed with a sample. The meter reads the current and gives ablood sugar result. |
| Test Strip storageconditions | Store the test strips at room temperature (less than 90°F); do not freeze. |
| Quality controlprocedures | User is directed to perform quality control testing: when the cap is leftoff the vial of test strips, when a new vial is opened, if the meter isdropped, if the result does not agree with the way the user feels,whenever the user wishes to check the performance of the system. |
| Altitude | 10,150 feet |
| Reportable range | 10 - 600 mg/dL |
| Warnings andprecautions | Both systems are for in vitro diagnostic use only. |
| Active reagentcomposition | Glucose dehydrogenase |
| Monitor codingprocess | Both systems use a code key, included in the test strip vial, inserted intothe meter. |
| Test strip packaging | Both systems provide test strips in a desiccated vial. |
| Identification ofcontrol solutions | Both systems automatically distinguish control solutions from wholeblood samples. |
Continued on next page
{2}------------------------------------------------
510(k) Summary, Continued
- Similarities to predicate device, cont.
Feature/Claim Detail Test sample volume 0.6 µL Test time 5 seconds Expiration In addition to information included in labeling, the code key contains expiration date of associated test strips. System informs user when code key has expired. The system utilizes both AC/DC electrical impedance information. Test strip technology The normal fasting blood glucose range for an adult without diabetes Labeling instructions is 74 - 106 mg/dL. Two hours after meals, the blood glucose range regarding expected for an adult without diabetes is less than 140 mg/dL. For people with results diabetes: consult your doctor for the blood glucose range appropriate for you.
- Difference to predicate device
| Topic | ACCU-CHEK Aviva Pro TestStrips | ACCU-CHEK Aviva |
|---|---|---|
| Sample Types | Whole blood (capillary, venous,arterial, and neonate) | Whole blood samples (capillaryand venous) |
| Hematocrit | 10 - 70% | 20 - 70% |
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Scott Thiel, MT(ASCP), MBA Regulatory Affairs Program Principal Roche Diagnostics, Inc. 9115 Hague Road Indianapolis, IN 46250-0416
AUG 1 1 2006
Re: K060620
Trade/Device Name: ACCU-CHEK® Aviva Test Strips Regulation Number: 21 CFR8862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: LFR, NBW Dated: July 24, 2006 Received: July 25, 2006
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).
{4}------------------------------------------------
Page 2 -
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Garcia, Ph.D.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known):__ K060620
Device Name: ____ ACCU-CHEK® Aviva Test Strips
Indications For Use:
The ACCU-CHEK Aviva Test Strips are used with the ACCU-CHEK Aviva meter. The ACCU-CHEK Aviva test system is designed to quantitatively measure the concentration of glucose for monitoring glucose in the home or in health care facilities. Testing sites include traditional fingertip site along with palm, forearm, upper arm, thigh, and calf.
Professionals may use the test strips to test capillary, venous, arterial, and neonatal blood; home use is limited to capillary whole blood testing.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
C.A.C. i
Office of Home - Domestic Device
510(k) K060620
Page 1 of
§ 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.