(94 days)
The software is intended to assist health care professional and people with diabetes review and analyze blood glucose test results. The device is not intended to provide any diagnosis on patient results.
Accessory to Accu-Chek brand meters that enables the person with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support effective diabetes management.
The provided 510(k) summary for the Diabetes Assistant Software (K014139) does not contain specific acceptance criteria, performance data, or details of a study that proves the device meets such criteria.
The submission is focused on demonstrating substantial equivalence to a predicate device (Camit Diabetes Management Software) based on functional similarities and intended use. There is no mention of a clinical or performance study with detailed methodologies, sample sizes, ground truth establishment, or expert involvement to evaluate the device's efficacy or accuracy against specific benchmarks.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.
The document primarily states:
- Intended use: To assist healthcare professionals and people with diabetes in reviewing and analyzing historical blood glucose test results. It explicitly states the device is "not intended to provide any diagnosis on patient results."
- Comparison to predicate device: The submission lists features where the Diabetes Assistant Software is similar to the Camit Diabetes Management Software, such as intended use, meters supported, customer support, data storage, reports/graphs, tracking of non-blood glucose data, multiple patient support, password protection, and embedded help.
This type of submission often relies on the predicate device's established performance and the demonstration that the new device does not introduce new questions of safety or effectiveness.
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MAR 2 1 2002
510(k) Summary K014139 According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Roche Diagnostics Corporation 1) Submitter name, address, 9115 Hague Rd. Indianapolis, IN 46250 contact (317) 521-2000 ext. 3362 Contact Person: Scott Thiel Date Prepared: December 13, 2001 Proprietary name: Diabetes Assistant Software 2) Device name Classification name: calculator/data processing module for clinical use (21 C.F.R. § 862.1345) We claim substantial equivalence to the current legally marketed Camit 3) Predicate device Diabetes Management Software. Accessory to Accu-Chek brand meters that enables the person with diabetes 4) Device and their health care professionals in review, analysis and evaluation of Description historical blood glucose test results to support effective diabetes management. The software is intended to assist health care professional and people with 5) Intended use diabetes review and analyze blood glucose test results. The device is not intended to provide any diagnosis on patient results. Continued on next page
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510(k) Summary, Continued
Comparison to Predicate Device
and the same of the same of the same of the same
The Roche Diagnostics Diabetes Assistant is substantially equivalent to the Similarities The Roome Diagnobated version Camit Diabetes Management software. The earrent logally into of some of the claims and features unaffected by the proposed modification. .
| Feature/Claim | Detail |
|---|---|
| Intended use | The software is intended to assist health care professional and people withdiabetes review and analyze blood glucose test results. The device is notintended to provide any diagnosis on patient results. |
| Meters upload | Specified Accu-Chek meters. |
| Support | Through Accu-Chek Customer CareSM |
| Data storage | On computer media. |
| Reports and graphs | Similar graphs and reports can be generated for viewing on a displayscreen, and hard copy printout. |
| Track non-bloodglucose data | Tracks similar data sets. (i.e. Carbohydrates, insulin, timeblocks, eventcodes) |
| Multiple patients | Similar ability to support multiple patients in the same database |
| Password Protection | Similar ability to password protect the user's data |
| Embedded help | Similar method to receive help while in the program |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures connected at the shoulders, representing health, services, and the connection between them.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 1 2002
Mr. Scott Thiel Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
K014139 Re:
Trade/Device Name: Diabetes Assistant Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA Dated: March 1, 2002 Received: March 4, 2002
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 for abounded in the 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 11 your de subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 r read on actived a determination that your device complies with other requirements of the Act that I Drederal 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will anon you to or gift substantial equivalence of your device to a legally marketed nothcation. THE I DFF 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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 60710 Horionally, for questions on the promotion and advertising of your device, (301) 594-4500. Raundination at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsiver Assistance at its toll-free number (800) 638-2041 or 11andracter anternet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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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Indications for Use Statement
510(k) Number (if known): Device Name: Diabetes Assistant software
Indications for Use:
The software is intended to assist health care professional and people with diabetes review and The software is intended to assist notificated in provide any diagnosis on patient results.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use ✓
(Optional Format 1-2-96)
e.A
vision Sign-Off) Division of Clinice | Laboratory Devices KA14139 510(k) Number
§ 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.