(50 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components.
No
The device is described as a "Blood Glucose Monitoring System" and is used for "quantitative measurement of glucose" as an "aid to monitor the effectiveness of diabetes control." This indicates it is a diagnostic tool, not a device that directly treats or cures a condition.
Yes
The device is explicitly stated as an "in vitro diagnostic use" system, intended to measure glucose in blood to aid in monitoring the effectiveness of diabetes control.
No
The device description explicitly lists hardware components such as a meter, test strips, control solutions, lancing devices, and lancets, indicating it is a hardware-based system with software likely embedded within the meter.
Yes, the device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The OneTouch® Vita™ System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control."
This statement clearly identifies the device as being for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The OneTouch® Vita™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Vita™ System is intended for self-testing outside the body (in vitro diagnostic use) by people 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 Vita™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
Product codes
NBW, CGA
Device Description
The OneTouch® Vita™ Blood Glucose Monitoring System consists of the OneTouch® Vita™ Meter; OneTouch® Vita™ Test Strips (provided separately); OneTouch® Vita™ Control Solution and OneTouch® Vita™ High Control Solution (provided separately); either the OneTouch® UltraSoft® Adjustable Blood Sampler with OneTouch® UltraClear® Cap or the OneTouch® Lancing Device with OneTouch® AST ClearCap; and OneTouch® UltraSoft Sterile Lancets.
The OneTouch® Vita™ meter is a modification of the OneTouch® Select™ and OneTouch® Ultra®2 meters. The OneTouch® Vita™ test strip is a modification of the OneTouch® Ultra® test strip (component of the OneTouch® Ultra®2 Blood Glucose Monitoring System).
There are no changes to other system testing components compared to the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger, forearm or palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare professionals in a clinical setting
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)
A comparison of system accuracy performance demonstrated that the OneTouch Vita™ Blood Glucose Monitoring System is substantially equivalent to the currently marketed OneTouch® Select™ and OneTouch® Ultra®2 Blood Glucose Monitoring Systems.
Design Verification testing (including software verification and validation testing) confirmed that the performance, safety, and effectiveness of the OneTouch® Vita™ Blood Glucose Monitoring System is equivalent to that of the predicate devices.
The modified blood glucose monitoring system (meter and test strip) 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 usability of the device (human factors) in the hands of intended users and validated comprehension of the proposed product labeling.
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.
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
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
Image /page/0/Picture/1 description: The image shows the LifeScan logo, which includes the word "LIFESCAN" in bold, sans-serif font. Below the word "LIFESCAN" is the phrase "a Johnson & Johnson company" in a smaller, lighter font. To the left of the word "LIFESCAN" is a graphic element that appears to be a stylized representation of a blood drop or a similar shape. The logo has a sleek and modern design.
OCT 2 2 2008
OneTouch® Vita™ Blood Glucose Monitoring System
510(k) Summary
| Sponsor | LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, CA 95035 U.S.A. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent | Primary 510(k) Contact (submitter):
Oyinkan Donaldson
LifeScan Scotland Ltd.
Beechwood Park North
Inverness, IV2 3ED
United Kingdom
Phone: 011-44-1463-721259
e-mail: odonalds@its.jnj.com
Secondary 510(k) Contact:
Mary Ellen Holden
LifeScan Inc.
1000 Gibraltar Drive
Milpitas, CA 95035 U.S.A.
Phone: 408 942 3589
e-mail: mholden@lfsus.jnj.com |
| Device Name and
Classification | OneTouch® Vita™ Blood Glucose Monitoring System
Common name: Glucose test system
Classification:
(1) OneTouch® Vita™ Blood Glucose Meters and
OneTouch® Vita ™ Test Strips are Class II
devices
(21 CFR § 862.1345)
(2) OneTouch® Vita™ Control Solutions are a Class I
device (21 CFR § 862.1660)
(3) OneTouch® Lancing Device with OneTouch® AST
ClearCap™, OneTouch® UltraSoft® Adjustable
Blood Sampler with OneTouch® UltraClear® Cap
and OneTouch® UltraSoft® Sterile Lancets are
Class I (exempt) devices (21 CFR § 878.4800) |
1
Image /page/1/Picture/0 description: The image shows the LifeScan logo. The logo features the word "LIFESCAN" in bold, sans-serif font. Below the word is the text "johnson johnson company" in a smaller, cursive font. To the left of the word is a graphic of a globe with a curved line extending from the bottom left to the top right.
System Description
The OneTouch® Vita™ Blood Glucose Monitoring System consists of the OneTouch® Vita™ Meter; OneTouch® Vita™ Test Strips (provided separately); OneTouch® Vita™ Control Solution and OneTouch® Vita™ High Control Solution (provided separately); either the OneTouch® UltraSoft® Adjustable Blood Sampler with OneTouch® UltraClear® Cap or the OneTouch® Lancing Device with OneTouch® AST ClearCap; and OneTouch® UltraSoft Sterile Lancets.
The OneTouch® Vita™ meter is a modification of the OneTouch® Select™ and OneTouch® Ultra®2 meters. The OneTouch® Vita™ test strip is a modification of the OneTouch® Ultra® test strip (component of the OneTouch® Ultra®2 Blood Glucose Monitoring System).
There are no changes to other system testing components compared to the predicate devices.
Predicate Devices - OneTouch® Select™ Blood Glucose Monitoring System (K072543, cleared 4th Oct 2007)
- OneTouch® Ultra®2 Blood Glucose Monitoring System (K053529, cleared 17 Jan 2006)
Intended Use
The OneTouch® Vita™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Vita™ System is intended for self-testing outside the body (in vitro diagnostic use) by people 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 Vita™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
Comparison to Predicate Devices
The device modifications encompass:
- Meter ergonomic/physical design and software/firmware changes . including removal of user coding step
- Test Strip changes to electrode layout and cosmetic appearance .
The OneTouch® Vita™ Blood Glucose Monitoring System has the same intended use, material composition and operating principle as the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the LifeScan logo, which includes the company name in bold, stylized letters. Below the company name, in smaller font, is the text "Johnson & Johnson company". To the left of the company name is a graphic element that appears to be a stylized globe or sphere with an arc extending from it.
Technological Characteristics
The OneTouch® Vita™ Blood Glucose Monitoring System has the same
fundamental scientific technology as the OneTouch® Select™ Blood Glucose Monitoring System and OneTouch® Ultra®2 Blood Glucose Monitoring System predicate devices.
Summary of Performance Characteristics
The OneTouch Vita™ Blood Glucose Monitoring System has the same performance characteristics as the OneTouch® Select™ Blood Glucose Monitoring System and OneTouch® Ultra 2 Blood Glucose Monitoring System predicate devices.
A comparison of system accuracy performance demonstrated that the OneTouch Vita™ Blood Glucose Monitoring System is substantially equivalent to the currently marketed OneTouch® Select™ and OneTouch® Ultra®2 Blood Glucose Monitoring Systems.
Design Verification testing (including software verification and validation testing) confirmed that the performance, safety, and effectiveness of the OneTouch® Vita™ Blood Glucose Monitoring System is equivalent to that of the predicate devices.
The modified blood glucose monitoring system (meter and test strip) 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 usability of the device (human factors) in the hands of intended users and validated comprehension of the proposed product labeling.
Conclusion
The OneTouch® Vita™ Blood Glucose Monitoring System is substantially equivalent to the OneTouch® Select™ Blood Glucose Monitoring System and OneTouch® Ultra®2 Blood Glucose Monitoring System predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure in black, with three distinct lines forming its body and wings. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 0 6 2008
LifeScan Inc. c/o Mrs. Ovinkan Donaldson 1000 Gibraltar Dr. Milpitas. CA 95035
K082513 Re: Trade Name: OneTouch Vita Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA Dated: September 18, 2008 Received: September 22, 2008
Dear Mrs. Donaldson:
This letter corrects our substantially equivalent letter of October 22, 2008.
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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Page 2 -
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.
Yéan 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
5
Indications for Use
510(k) Number (if known): __