(24 days)
K#031755
Not Found
No
The summary describes a photometric glucose monitoring system based on glucose dehydrogenase, with no mention of AI, ML, image processing, or any related concepts. The performance studies focus on accuracy and precision compared to a reference method and predicate device, which is standard for this type of device and does not indicate AI/ML use.
No
The device is designed for monitoring glucose levels, not for treating a disease or condition.
Yes
The device is designed to "quantitatively measure the concentration of glucose in capillary whole blood," which aims to monitor glucose levels for individuals with diabetes, indicating its use in identifying and tracking a health condition.
No
The device description explicitly mentions an "Instrument Operating Principle -- photometry" and "Reagent Test Principle -- glucose dehydrogenase," indicating the use of hardware components (a meter and test strips) 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 intended use explicitly states that 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).
- Device Description: The operating principle (photometry) and reagent test principle (glucose dehydrogenase) are methods used to analyze the chemical composition of a sample in vitro.
- Anatomical Site: While the blood is collected from an anatomical site, the testing itself is performed on the collected blood sample, not directly on the body.
Therefore, based on the provided information, the Accu-Chek Go system fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
LFR, NBW
Device Description
Instrument Operating Principle -- photometry
Reagent Test Principle -- glucose dehydrogenase
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
persons with diabetes or by health care professionals for monitoring glucose 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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#031755
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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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 Corporation |
| 9115 Hague Rd. | |
| Indianapolis, IN 46250 | |
| (317) 845-2000 | |
| Contact Person: Scott Thiel | |
| Date Prepared: April 20, 2004 | |
| 2) Device name | Proprietary name: Accu-Chek Go 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 Compact System (K#031755). |
| 4) Device Description | Instrument Operating Principle -- photometry |
| Reagent 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. |
Continued on next page
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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 are |
| designed to quantitatively measure the concentration of glucose in | |
| capillary whole blood. The devices are 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. Both systems are indicated for | |
| Alternate Site Testing use. | |
| Test principle | Glucose dye oxidoreductase mediator reaction. |
| Test strip storage | |
| conditions | Store at room temperature between +36° F (+2° C) and +86° F (+30° C). |
| Test strip operating | |
| conditions | Between +5° F (+10° C) and +104° F (+40° C). |
| Quality control | |
| testing frequency | 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. | |
| Quality control | |
| acceptable range | The mean is strip lot specific and will be determined individually. The |
| range of the controls is within $\pm$ 15 mg/dL or $\pm$ 15% compared to the | |
| determined mean. | |
| Labeling | |
| instructions | |
| regarding expected | |
| results | 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. | |
| Labeling | |
| instructions | |
| regarding response | |
| to unusual results | Run a quality control test, if the result is outside the acceptable QC |
| recovery range contact Roche Diagnostics' 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. | |
| Acceptable sample | |
| types | Capillary whole blood samples from a fingerstick or AST site. Venous |
| blood may also be used only if drawn by health care professionals. | |
| Reportable range | 10-600 mg/dL |
| Hematocrit range | 25-65% |
| Warnings and | |
| precautions | For in vitro diagnostic use only. |
Continued on next page
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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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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 (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