(24 days)
The Accu-Chek Go system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring glucose 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 and venous blood samples; lay use is limited to capillary whole blood testing.
Instrument Operating Principle -- photometry
Reagent Test Principle -- glucose dehydrogenase
Here's a breakdown of the acceptance criteria and study information for the Accu-Chek Go System based on the provided 510(k) summary:
The document states that a multi-center performance study was conducted to evaluate the accuracy and precision of the modified device, and all predetermined acceptance criteria were satisfied. However, the document does not explicitly list the specific acceptance criteria or the reported device performance in a table format. It only states that the device "correlates well with the laboratory plasma glucose reference test method." More detailed information regarding the specific criteria (e.g., specific bias percentages, error grid analysis zones, or precision CVs) and the performance results would typically be found in the full study report, which is not provided here.
Therefore, the table below uses the information available in the provided text, acknowledging that the specific performance metrics for the acceptance criteria are not detailed.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied/General) | Reported Device Performance (Summary) |
|---|---|
| Accuracy (Correlation with reference method) | Device correlates "well with the laboratory plasma glucose reference test method." |
| Precision | Predetermined precision requirements were satisfied. |
Note: The 510(k) summary explicitly states that "All predetermined acceptance criteria were satisfied," but does not detail the quantitative cutoffs for these criteria or the specific performance metrics achieved (e.g., specific bias percentages, error grid analysis zones, or precision CVs).
2. Sample Size and Data Provenance for the Test Set
The document does not specify the exact sample size used for the test set. It only mentions "A multi-center performance study was conducted."
Regarding data provenance, the document indicates:
- Country of Origin: Not explicitly stated, but given Roche Diagnostics Corporation's location (Indianapolis, IN) and the FDA approval process, it's highly likely that at least some, if not all, of the data originated from the United States.
- Retrospective or Prospective: Not explicitly stated. However, "A multi-center performance study was conducted" generally implies a prospective study where data is collected specifically for the purpose of the device evaluation.
3. Number of Experts and Qualifications for Ground Truth Establishment
The document does not provide information on:
- The number of experts used to establish the ground truth for the test set.
- The qualifications of those experts.
- Given the nature of a glucose meter, the "ground truth" is typically established by laboratory reference methods rather than expert consensus on subjective findings.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. This is generally not relevant for quantitative medical devices like blood glucose meters where the ground truth is established by a quantitative laboratory reference method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable for a standalone glucose meter. MRMC studies are typically used for imaging interpretation devices where human readers interpret medical images, and the study assesses the impact of AI assistance on their diagnostic performance. This device is a standalone quantitative measurement system.
6. Standalone (Algorithm Only) Performance
Yes. The study conducted was a standalone performance study of the Accu-Chek Go System. The glucose meter itself (the "algorithm" in this context) directly measures and reports glucose concentration without human interpretation in the results generation process. The summary explicitly states: "Performance testing on the modified Accu-Chek Go System demonstrated that the device meets the performance requirements for its intended use." This focuses on the device's intrinsic accuracy and precision compared to a reference method.
7. Type of Ground Truth Used
The ground truth used was laboratory plasma glucose reference test method. The document states that the device's performance "correlates well with the laboratory plasma glucose reference test method." This indicates that the device's readings were compared against an established, highly accurate laboratory instrument.
8. Sample Size for the Training Set
The document does not provide information on the sample size used for the training set. For medical devices, especially quantitative ones, the "training set" might refer to data used during the development and calibration phases of the device, rather than a distinct, separate dataset used for machine learning model training in the AI sense.
9. How the Ground Truth for the Training Set was Established
The document does not provide information on how the ground truth was established for a training set. Similar to point 8, if a "training set" was used for calibration or development, the ground truth would likely have been established using a laboratory reference method, consistent with how the test set ground truth was determined.
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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 | Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000Contact Person: Scott ThielDate Prepared: April 20, 2004 |
| 2) Device name | Proprietary name: Accu-Chek Go 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 Compact System (K#031755). |
| 4) Device Description | Instrument Operating Principle -- photometryReagent Test Principle -- glucose dehydrogenase |
| 5) Intended use | The Accu-Chek Go system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring glucose 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 and venous blood samples; lay use is limited to capillary whole blood testing. |
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510(k) Summary, Continued
The Roche Diagnostics Accu-Chek Go (modified) System is 6) Similarities substantially equivalent to the current legally marketed Accu-Chek Compact (predicate) System. The following is a list of some of the claims and features unaffected by the proposed modification.
| Feature/Claim | Detail |
|---|---|
| Intended use | The Accu-Chek Go and Accu-Chek Compact systems aredesigned to quantitatively measure the concentration of glucose incapillary whole blood. The devices are indicated for professionaluse and over-the-counter sale. Professionals may use the teststrips to test capillary and venous blood samples; lay use is limitedto capillary whole blood testing. Both systems are indicated forAlternate Site Testing use. |
| Test principle | Glucose dye oxidoreductase mediator reaction. |
| Test strip storageconditions | Store at room temperature between +36° F (+2° C) and +86° F (+30° C). |
| Test strip operatingconditions | Between +5° F (+10° C) and +104° F (+40° C). |
| Quality controltesting frequency | Tests should be run with liquid quality control materials whenever a newvial of test strips is opened or an unusual blood test result is obtained. |
| Quality controlacceptable range | The mean is strip lot specific and will be determined individually. Therange of the controls is within $\pm$ 15 mg/dL or $\pm$ 15% compared to thedetermined mean. |
| Labelinginstructionsregarding expectedresults | 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 levelsshould be less than 140 mg/dL. Doctors will determine the range that isappropriate for the patients. |
| Labelinginstructionsregarding responseto unusual results | Run a quality control test, if the result is outside the acceptable QCrecovery range contact Roche Diagnostics' Accu-Chek Customer Carecenter; if result is within the acceptable range, review proper testingprocedure and repeat blood glucose test with a new test strip. |
| Acceptable sampletypes | Capillary whole blood samples from a fingerstick or AST site. Venousblood may also be used only if drawn by health care professionals. |
| Reportable range | 10-600 mg/dL |
| Hematocrit range | 25-65% |
| Warnings andprecautions | For in vitro diagnostic use only. |
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510(k) Summary, Continued
- Data demonstratin g substantial equivalence
Performance testing on the modified Accu-Chek Go System demonstrated that the device meets the performance requirements for its intended use. A multi-center performance study was conducted to evaluate the accuracy and precision of the modified device. The clinical data demonstrates that the performance of the Accu-Chek Go correlates well with the laboratory plasma glucose reference test method. All predetermined acceptance criteria were satisfied. The data also demonstrates that the Accu-Chek Go is substantially equivalent to the predicate device.
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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 depiction of an eagle in flight, composed of three curved lines. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
APR 2 2 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Scott Thiel Regulatory Affairs/Diabetes Specialist Roche Diagnostics Corp. 9115 Hague Road Indianapolis, IN 46250
K040796 Re:
Trade/Device Name: Accu-Chek Go Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: LFR, NBW Dated: March 25, 2004 Received: March 29, 2004
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,
Jean M. Cooper, US, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K040796
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Accu-Chek Go system is designed to quantitatively measure the concentration The Accu-Chek Go system is dealghoute to qualifically of the librath care focilition of glucose in Capillary whole Blood by person in health care facilities. The professionals for monitoning graves and over-the-counter sale.
Professionals may use the test strips to test capillary and venous blood samples; lay use is limited to capillary whole blood testing.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
.The-Counter Use
(CFR 807 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)
Division Sign-Off
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Office of In Vitro Diagnostic Device Evaluation and Sc
510(k) K040796
§ 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.