(88 days)
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.
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.
The provided text is a 510(k) summary for the ONE TOUCH® Basic/Profile/ONE TOUCH® II Test Strips. It focuses on demonstrating substantial equivalence to a predicate device, primarily through a change in test strip dimensions to allow for a smaller blood drop. The document does not contain the detailed information necessary to answer all the points of your request regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML powered device.
Here's an breakdown of what can be extracted and what is missing, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "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%)."
However, it does not provide a specific table of acceptance criteria (e.g., accuracy metrics like bias, standard deviation, or specific error grid analysis targets commonly used for glucose meters) nor the reported device performance data against those criteria. It only makes a general statement about equivalence regarding hematocrit range.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any testing. It also does not provide data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable and not provided in this document. The device is a blood glucose meter, and its 'ground truth' for glucose measurement typically refers to a reference laboratory method, not expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used when human interpretation (e.g., of images) is involved in establishing ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable and not provided. This is not an AI/ML powered device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance would be relevant or conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is a standalone blood glucose meter. Its performance is inherent in its design and operation. The statement "The performance of the modified test strip has been shown to be equivalent to that of the predicate..." implies a standalone performance comparison. However, specific details about a "standalone study" with detailed methodologies and results are not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a blood glucose meter, the 'ground truth' would typically be reference laboratory glucose measurements (e.g., using a YSI glucose analyzer or a similar laboratory-grade method). However, the document does not explicitly state the type of ground truth used.
8. The sample size for the training set
The document does not mention a "training set" as this is not an AI/ML device. The "training" in the context of a blood glucose meter typically refers to the calibration (entering a code for each lot of test strips), not a machine learning training phase.
9. How the ground truth for the training set was established
As there is no "training set" in the AI/ML context, this information is not applicable and not provided.
Summary of what is available from the document:
The provided 510(k) summary focuses on demonstrating that a modification to an existing blood glucose test strip (ONE TOUCH® Basic/Profile/ONE TOUCH® II Test Strips) does not alter its fundamental performance. The key assertion is that 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%)." This implies that the acceptance criteria for equivalence related to hematocrit performance were met, but the specific criteria and corresponding performance data are not detailed in this public summary document.
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510(k) Summary
| Submitter | LifeScan, Inc.1000 Gibraltar DriveMilpitas, CA 95035Contact: Frank PeraltaDate Prepared: May 8, 2003 |
|---|---|
| Device Name | ONE TOUCH® Basic/Profile/ONE TOUCH® II Test StripsCommon 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 _
§ 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.