(25 days)
The OneTouch® Select™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Select™ System is intended for self-testing outside the body (in vitro diagnostic use) by pcople with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch® Select™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
The OneTouch® Select™ Blood Glucose Monitoring System consists of the OneTouch® Select™ Meter, OneTouch® Select™ Test Strips (provided separately), OneTouch® Select™ Control Solution (provided separately), OneTouch® Select™ High Control Solution (provided separately), either the OneTouch® UltraSoft® Adjustable Blood Sampler with OneTouch® UltraClear® Cap or the OneTouch® Lancing Device with Onc Touch® AST ClearCap and OneTouch® UltraSoft Sterile Lancets.
The OneTouch® Select™ meter, test strip and high control solution are modifications of the OneTouch Ultra 2® meter, test strip and normal control solution, respectively.
There are no changes to other system testing components compared to the currently marketed product.
The OneTouch® Select™ Blood Glucose Monitoring System was tested and found to be substantially equivalent to the predicate OneTouch Ultra 2 Blood Glucose Monitoring System.
Here's a breakdown of the requested information, although some details (like specific sample sizes for training sets and the exact number/qualifications of experts) are not explicitly provided in the summary:
1. Table of Acceptance Criteria and Reported Device Performance
The summary states that the modified blood glucose monitoring system was tested in accordance with ISO 15197:2003(E). This standard outlines acceptance criteria for the accuracy of blood glucose monitoring systems. While the exact numerical criteria from ISO 15197:2003(E) are not listed in this summary, the document asserts that the "System accuracy performance demonstrated that the OneTouch® Select™ Blood Glucose Monitoring System and the currently marketed OneTouch Ultra 2 Blood Glucose Monitoring System are substantially equivalent."
Therefore, the acceptance criteria would be those defined by ISO 15197:2003(E), and the performance reported is that it met these criteria as being substantially equivalent to the predicate device.
| Acceptance Criteria (based on ISO 15197:2003(E) - specific thresholds not stated in text) | Reported Device Performance (Relative to predicate device) |
|---|---|
| System Accuracy (e.g., % of results within specific ranges of reference method) | Demonstrated substantial equivalence in accuracy |
| Repeatability (Precision) | Tested and demonstrated |
| Intermediate Precision | Tested and demonstrated |
| User performance assessment (accuracy of results and usability) | Assessed and validated |
| Comprehension of product labeling | Validated |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the analytical performance testing (system accuracy, repeatability, intermediate precision) or the user performance evaluation.
- Data Provenance: Not explicitly stated, but the testing would typically be prospective for such performance studies. Given LifeScan's global presence, the data would likely be collected in a controlled clinical or laboratory setting as part of the design verification process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: For ground truth in blood glucose measurements, this would typically involve laboratory reference methods and highly trained medical laboratory professionals rather than "experts" in the sense of radiologists. The "User performance evaluation" would assess accuracy by intended users (people with diabetes and healthcare professionals), but the ground truth for glucose values would be established by a reference laboratory method.
4. Adjudication Method for the Test Set
- Not applicable as the ground truth for blood glucose measurements is typically established by precisely calibrated and traceable laboratory reference methods, not subjective interpretation requiring adjudication among multiple human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC study was not done. This type of study is relevant for medical imaging where human readers interpret cases. For a blood glucose monitoring system, the primary evaluation is the accuracy of the device's measurement compared to a reference method, rather than human interpretation of device output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance study was done. "Analytical performance testing included system accuracy, repeatability and intermediate precision testing." This refers to the device's inherent ability to measure glucose values accurately and precisely, independently of user interaction for the measurement itself (though user interaction is a separate usability test).
7. The Type of Ground Truth Used
- The ground truth for blood glucose measurement studies is typically established by laboratory reference methods. These are highly accurate and precise methods (e.g., hexokinase method) performed in a clinical laboratory to determine the true blood glucose concentration against which the device's readings are compared.
8. The Sample Size for the Training Set
- The document does not provide information regarding a specific "training set" or its size. For a blood glucose meter, the "training" (calibration) is inherent in its design and manufacturing. Any iterative development might involve internal testing, but a distinct "training set" like in machine learning is not typically detailed in 510(k) summaries for these devices.
9. How the Ground Truth for the Training Set Was Established
- As a "training set" is not explicitly mentioned in the context of this device's regulatory submission, the method for establishing its ground truth is not provided. The ground truth for the device's validation (test set) is established using laboratory reference methods.
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Image /page/0/Picture/0 description: The image shows the LifeScan logo, which is a black oval shape with the words "LIFESCAN" in bold, black letters. Below the company name is the text "Johnson & Johnson company" in a smaller font. The logo is simple and modern, and the use of black and white gives it a clean and professional look. The logo is likely used to represent the company and its products.
0CT 5 * 2007
0 neTouch® Select™ Blood GlucoseM onitoring System
510 k) Sum m ary
| Sponsor | LifeScan, Inc.1000 Gibraltar DriveMilpitas, CA 95035 U.S.A. |
|---|---|
| Correspondent | Primary 510(k) Contact:Alison WilsonLifeScan Scotland Ltd.Beechwood Park NorthInverness, IV2 3EDUnited KingdomPhone: 011-44-1463-721256e-mail: awilson4@lfsgb.jnj.comAlternate 510(k) Contact:Mary Ellen HoldenLifeScan Inc.1000 Gibraltar DriveMilpitas, CA 95035 U.S.A.Phone: 408 942 3589E-mail: Mholden@lfsus.jnj.com |
| Device Name andClassification | OneTouch® Select™ Blood Glucose Monitoring SystemCommon name: Glucose test systemClassification:(1) OneTouch® Select™ Blood Glucose Meters andOneTouch® Select™ Test Strips are Class II devices(21 CFR § 862.1345)(2) OneTouch® Select™ Control Solutions are a Class Idevice (21 CFR § 862.1660)(3) OneTouch® Lancing Device with OneTouch® ASTClearCap™, OneTouch® UltraSoft® Adjustable BloodSampler with OneTouch® UltraClear® Cap andOneTouch® UltraSoft® Sterile Lancets are Class I(exempt) devices (21 CFR § 878.4800) |
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Image /page/1/Picture/0 description: The image shows the logo for LifeScan, a Johnson & Johnson company. The logo features the word "LIFESCAN" in bold, black letters. Below the company name is the text "a Johnson & Johnson company" in a smaller font. The logo also includes a graphic element that resembles a stylized orbit around the company name.
System Description
The OneTouch® Select™ Blood Glucose Monitoring System consists of the OneTouch® Select™ Meter, OneTouch® Select™ Test Strips (provided separately), OneTouch® Select™ Control Solution (provided separately), OneTouch® Select™ High Control Solution (provided separately), either the OneTouch® UltraSoft® Adjustable Blood Sampler with OneTouch® UltraClear® Cap or the OneTouch® Lancing Device with Onc Touch® AST ClearCap and OneTouch® UltraSoft Sterile Lancets.
The OneTouch® Select™ meter, test strip and high control solution are modifications of the OneTouch Ultra 2® meter, test strip and normal control solution, respectively.
There are no changes to other system testing components compared to the currently marketed product.
Predicate Device OneTouch® Ultra® 2 Blood Glucose Monitoring System
Intended U se
The OneTouch® Sclect™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Select™ System is intended for self-testing outside the body (in vitro diagnostic use) by pcople with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch® Select™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
C om parison to Predicate D evice
The modifications to the device encompass:
- . M eter : ergonomic/physical design, electronic/hardware, software/firmware changes.
- . Test Strip: changes to appearance and layout of electrodes
- ControlSolution : availability of a second level of control .
There has been no change to the intended use, operating principle, functionality, or material composition of the device.
Technological C haracteristics
There has been no change to the fundamental scientific technology.
Summary of Perform ance Characteristics
There has been no change to the performance characteristics of the system.
A comparison of system accuracy performance demonstrated that the OneTouch® Select™ Blood Glucose Monitoring System and the currently marketed OneTouch Ultra 2 Blood Glucose Monitoring System are substantially equivalent.
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Design Verification testing (including software verification and validation testing) Dosign Vormediten working (more and effectiveness of the OneTouch® Select™ economical mae Monitoring System were equivalent to that of the predicate device.
The modified blood glucose monitoring system (meter, strips, and control) was tested in accordance with ISO 15197:2003(E). Analytical performance testing included system accuracy, repeatability and intermediate precision testing. A User performance evaluation assessed accuracy of results and usability of the device (human factors) in the hands of intended users. In addition, comprehension of the proposed product labeling was validated.
C onclusion
The OneTouch® Sclect™ Blood Glucose Monitoring System is substantially equivalent to the predicate OneTouch Ultra 2 Blood Glucose Monitoring System.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
LifeScan, Inc. c/o Ms. Alison Wilson Regulatory Affairs Specialist 1000 Gibraltar Drive Milpitas, CA 95035-6312
OCT 5 2007
Re: K072543
Trade/Device Name: OneTouch® Select™ Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: September 07, 2007 Received: September 10, 2007
Dear Ms. Wilson:
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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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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., 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): ____________________________________________________________________________________________________________________________________________________
Device Name: OneTouch® Select™ Blood Glucose Monitoring System
Indications For Use:
The OneTouch Select Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Select System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes in a home setting and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.
The OneTouch Select Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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| 510(k) | K072543 |
§ 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.