(88 days)
ONE TOUCH® Basic/Profile/ONE TOUCH® II Test Strips
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No
The description details a standard enzymatic reaction and reflectance photometry for glucose measurement, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is an in vitro diagnostic product intended to measure glucose levels, not to treat a condition.
Yes
The device is described as an "in vitro diagnostic product" and its intended use is to provide a quantitative measurement of glucose in whole blood.
No
The device description explicitly states it consists of a test strip (hardware) and a reflectance photometer (hardware), in addition to data management software. It is a system with both hardware and software components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quantitative measurement of glucose in whole blood as an aid in managing their glycemic state." This is a diagnostic purpose performed on a biological sample (whole blood).
- Device Description: The description clearly states, "The ONE TOUCH® Blood Glucose Monitoring System is an in vitro diagnostic product..." This directly identifies the device as an IVD.
- Mechanism: The description details a chemical reaction occurring on the test strip with the blood sample to produce a measurable result (color intensity proportional to glucose). This is a characteristic of in vitro diagnostic tests.
- Sample Type: The device uses "whole blood," which is a biological sample tested outside of the body (in vitro).
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ONE TOUCH® Basic/Profile/ONE TOUCH® II Test Strips are intended for use with ONE Touch ® Brand meters by healthcare professionals and laypersons with diabetes at home to provide a quantitative measurement of glucose in whole blood as an aid in managing their glycemic state.
Product codes
NBW, CGA
Device Description
The ONE TOUCH® Blood Glucose Monitoring System is an in vitro diagnostic product consisting of a test strip impregnated with reagents and a reflectance photometer for the determination of glucose in whole blood. Several different ONE Touch ® Brand reflectance photometers may be used (the ONE TOUCH ® Basic, ONE Touch ® II, or the ONE TOUCH ® Profile Meter). A quality control solution, ancillary devices to aid obtaining a capillary blood sample (lancets and lancing device) as well as data management computer software are also available.
A ONE Touch ® Test Strip is inserted into the meter and a drop of blood applied to the test spot. Glucose oxidase present in the test strip catalyzes the reaction of qlucose in the sample with oxygen to yield gluconic acid and hydrogen peroxide. Hydrogen peroxide subsequently oxidizes dyes in the test strip in the presence of peroxidase, a second enzyme, to produce a blue colored form of the dyes. The intensity of the blue color produced is proportional to the amount of glucose in the sample. The meter measures the amount of light reflected by the blue product and converts it to a glucose concentration that is presented on the meter display. The user adjusts the meter response for each lot of test strips by entering a calibration code that is specific to that lot into the meter.
No modifications to the intended use or to the fundamental scientific technology of the ONE Touch® Blood Glucose Monitoring System are being made. The description above applies to the currently marketed device and will apply equally to the modified device described in this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare professionals and laypersons with diabetes at home
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
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Summary of Performance Studies
The performance of the modified test strip has been shown to be equivalent to that of the predicate through the acceptable hematocrit range (30% to 55%).
Key Metrics
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Predicate Device(s)
ONE TOUCH® Basic/Profile/ONE TOUCH® II Test Strips
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
| Submitter | LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, CA 95035
Contact: Frank Peralta
Date Prepared: May 8, 2003 |
|------------------|----------------------------------------------------------------------------------------------------------------------|
| Device Name | ONE TOUCH® Basic/Profile/ONE TOUCH® II Test Strips
Common name: Glucose test strip |
| Predicate Device | ONE TOUCH® Basic/Profile/ONE TOUCH® II Test Strips |
Device Description
The ONE TOUCH® Blood Glucose Monitoring System is an in vitro diagnostic product consisting of a test strip impregnated with reagents and a reflectance photometer for the determination of glucose in whole blood. Several different ONE Touch ® Brand reflectance photometers may be used (the ONE TOUCH ® Basic, ONE Touch ® II, or the ONE TOUCH ® Profile Meter). A quality control solution, ancillary devices to aid obtaining a capillary blood sample (lancets and lancing device) as well as data management computer software are also available.
A ONE Touch ® Test Strip is inserted into the meter and a drop of blood applied to the test spot. Glucose oxidase present in the test strip catalyzes the reaction of qlucose in the sample with oxygen to yield gluconic acid and hydrogen peroxide. Hydrogen peroxide subsequently oxidizes dyes in the test strip in the presence of peroxidase, a second enzyme, to produce a blue colored form of the dyes. The intensity of the blue color produced is proportional to the amount of glucose in the sample. The meter measures the amount of light reflected by the blue product and converts it to a glucose concentration that is presented on the meter display. The user adjusts the meter response for each lot of test strips by entering a calibration code that is specific to that lot into the meter.
No modifications to the intended use or to the fundamental scientific technology of the ONE Touch® Blood Glucose Monitoring System are being made. The description above applies to the currently marketed device and will apply equally to the modified device described in this submission.
Intended Use
The ONE TOUCH® Basic/Profile/ONE TOUCH® II Test Strips are intended for use with ONE Touch ® Brand meters by healthcare professionals and laypersons with diabetes at home to provide a quantitative measurement of glucose in whole blood as an aid in managing their glycemic state.
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Comparison to Predicate Device
The dimensions of the ONE TOUCH® Test Strip have been altered to permit use of a smaller blood drop. The performance of the modified test strip has been shown to be equivalent to that of the predicate through the acceptable hematocrit range (30% to 55%).
Conclusion
The modified ONE TOUCH ®Test Strip is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is composed of three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the caduceus.
Mr. Frank Peralta Senior Regulatory Submissions Specialist LifeScan, Inc. 1000 Gibraltar Drive Milpitas, California 95035-6312
AUG - 5 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K031472
Trade/Device Name: One Touch® Basic/Profile/One Touch II Test Strip Regulation Number: 21 CFR § 862.1345 Regulation Name: System, Test, Blood Glucose, Over-the-Counter Regulatory Class: II Product Code: NBW. CGA Dated: May 8, 2003 Received: May 9, 2003
Dear Mr. Peralta:
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. Ilsting 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). 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.
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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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number:
Ko31/72
ONE TOUCH® Basic/Profile/ ONE Touch® II Test Strips Device Name:
Indications for Use:
The ONE TOUCH® Basic/Profile/ONE TOUCH® II Test Strips are intended for use with ONE TOUCH ® Brand meters by healthcare professionals and laypersons with diabetes at home to provide a quantitative measurement of glucose in whole blood as an aid in managing their glycemic state.
Alberto S
Division Sign-Off For: Jean Cooper
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031472
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use _