(168 days)
Not Found
Not Found
No
The summary describes a standard blood glucose monitoring system and explicitly states that AI, DNN, or ML were "Not Found" in the relevant sections.
No
The device is intended for quantitative measurement and monitoring of blood glucose levels, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as a "Blood Glucose Monitoring System" intended for "quantitative measurement of glucose in whole blood," which indicates its use in diagnosing or monitoring health conditions.
No
The device description explicitly includes hardware components such as the ONE TOUCH® II Hospital Meter, ONE TOUCH® Test Strips, control solutions, and the DataDock. While it mentions data management software, it is part of a larger system that includes physical devices.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in whole blood." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (whole blood) outside of the body to provide diagnostic information (glucose levels).
- Device Components: The system includes components like "ONE TOUCH® Test Strips" and "control solutions," which are typical reagents and consumables used in in vitro diagnostic testing.
- Anatomical Site: The anatomical site is "whole blood," which is a biological specimen analyzed in vitro.
The definition of an IVD generally involves devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The ONE TOUCH® II HOSPITAL Blood Glucose Monitoring System, consisting of the ONE TOUCH® II Hospital Meter, ONE TOUCH® Test Strips, control solutions, data management software, and the DataDock and other optional accessories is intended for quantitative measurement of glucose in whole blood in hospital, clinic, and home settings. It is intended for monitoring blood glucose levels in neonatal or non-neonatal whole blood samples. Non-neonatal blood glucose results can be reported in either whole blood equivalents or plasma/serum equivalents.
Product codes (comma separated list FDA assigned to the subject device)
CGA
Device Description
The DataDock is an optional accessory for the ONE TOUCH® II Hospital Meter. When the ONE TOUCH® II Hospital Meter is inserted into the DataDock, it provides features which improve ease-of-use and enhance data management capability.
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
neonatal or non-neonatal
Intended User / Care Setting
hospital, clinic, and home settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
510(k) Summary
DEC I S 1997
| Submitter | LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, CA 95037
John E. Hughes |
|---------------------|--------------------------------------------------------------------------------|
| Date | July 1, 1997 |
| Proprietary Name | ONE TOUCH® II Hospital Blood Glucose
Monitoring System
DataDock |
| Common Name | Blood Glucose Monitor |
| Classification Name | 75CGA Glucose oxidase, glucose |
Device Description
The DataDock is an optional accessory for the ONE TOUCH® II Hospital Meter. When the ONE TOUCH® II Hospital Meter is inserted into the DataDock, it provides features which improve ease-of-use and enhance data management capability.
Intended Use
The ONE TOUCH® II HOSPITAL Blood Glucose Monitoring System, consisting of the ONE TOUCH® II Hospital Meter, ONE TOUCH® Test Strips, control solutions, data management software, and the DataDock and other optional accessories is intended for quantitative measurement of glucose in whole blood in hospital, clinic, and home settings. It is intended for monitoring blood glucose levels in neonatal or non-neonatal whole blood samples. Non-neonatal blood glucose results can be reported in either whole blood equivalents or plasma/serum equivalents.
Substantial Equivalence
The DataDock is an optional accessory modifying the ONE TOUCH® II Hospital Blood Glucose Monitoring System currently in commercial distribution. The modification neither significantly changes the safety and effectiveness nor makes any change to its intended use of the device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 6 1997
John E. Hughes Manager, Regulatory Affairs LifeScan Inc. 1000 Gibraltar Drive Milpitas, California 95035-6312
K972473 Re : ONE TOUCH II DataDock Hospital Blood Glucose Monitoring System Regulatory Class: II Product Code: CGA October 1, 1997 Dated: October 3, 1997 Received:
Dear Mr. Hughes:
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, Drug, 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 against 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 regulations.
2
Page 2
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 entitled, "Misbranding by reference to premarket notification" (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 Sitman
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
3
510(k) Summary
DEC I S 1997
| Submitter | LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, CA 95037
John E. Hughes |
|---------------------|--------------------------------------------------------------------------------|
| Date | July 1, 1997 |
| Proprietary Name | ONE TOUCH® II Hospital Blood Glucose
Monitoring System
DataDock |
| Common Name | Blood Glucose Monitor |
| Classification Name | 75CGA Glucose oxidase, glucose |
Device Description
The DataDock is an optional accessory for the ONE TOUCH® II Hospital Meter. When the ONE TOUCH® II Hospital Meter is inserted into the DataDock, it provides features which improve ease-of-use and enhance data management capability.
Intended Use
The ONE TOUCH® II HOSPITAL Blood Glucose Monitoring System, consisting of the ONE TOUCH® II Hospital Meter, ONE TOUCH® Test Strips, control solutions, data management software, and the DataDock and other optional accessories is intended for quantitative measurement of glucose in whole blood in hospital, clinic, and home settings. It is intended for monitoring blood glucose levels in neonatal or non-neonatal whole blood samples. Non-neonatal blood glucose results can be reported in either whole blood equivalents or plasma/serum equivalents.
Substantial Equivalence
The DataDock is an optional accessory modifying the ONE TOUCH® II Hospital Blood Glucose Monitoring System currently in commercial distribution. The modification neither significantly changes the safety and effectiveness nor makes any change to its intended use of the device.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 6 1997
John E. Hughes Manager, Regulatory Affairs LifeScan Inc. 1000 Gibraltar Drive Milpitas, California 95035-6312
K972473 Re : ONE TOUCH II DataDock Hospital Blood Glucose Monitoring System Regulatory Class: II Product Code: CGA October 1, 1997 Dated: October 3, 1997 Received:
Dear Mr. Hughes:
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, Drug, 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 against 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 regulations.
5
Page 2
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 entitled, "Misbranding by reference to premarket notification" (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 Sitman
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
6
Indications for Use Form
510(k) Number (if known)
972473
Device Name:
ONE TOUCH® II Hospital Blood Glucose Monitoring System DataDock
Indications for Use
The ONE TOUCH® II HOSPITAL Blood Glucose Monitoring System, consisting of the ONE TOUCH® II Hospital Meter, ONE TOUCH® Test Strips, control solutions, data management software, the optional DataDock and other accessories is intended for quantitative measurement of glucose in whole blood in hospital, clinic, and home settings. It is intended for monitoring glucose levels in neonatal or non-neonatal whole blood samples. Non-neonatal glucose results can be reported in either whole blood equivalents or plasma/serum equivalents.
(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)
(Division Sign-Off)
Division of Clincal Laboratory Devices,
510(k) Number. 972473 134