(29 days)
Not Found
No
The document describes a standard blood glucose monitoring system and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
This device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, not for treating a disease or condition.
Yes
The text states that the system is an "aid to monitor the effectiveness of diabetes control," which implies a diagnostic purpose.
No
The device description explicitly lists hardware components like a meter, test strips, control solution, blood sampler, and lancets, indicating it is a system with physical components, not solely software.
Yes, the OneTouch Ultra 2 Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The "Intended Use / Indications for Use" section explicitly states: "The OneTouch Ultra 2 System is intended for use outside the body (in vitro diagnostic use)..."
- Function: The device measures glucose in fresh capillary whole blood, which is a biological sample taken from the body and analyzed in vitro (outside the body).
- Purpose: It is used as an aid to monitor the effectiveness of diabetes control, which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
The OneTouch Ultra 2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra 2 System is intended for use 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 Ultra 2 Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
Product codes
NBW, CGA
Device Description
The OneTouch Ultra 2 Blood Glucose Monitoring System consists of the OneTouch Ultra 2 Meter, OneTouch Ultra Test Strips (provided separately), OneTouch Ultra Control Solution, OneTouch UltraSoft Blood Sampler and OneTouch UltraSoft Sterile Lancets. The predicate OneTouch® Ultra® Meter has been modified to produce the OneTouch Ultra 2 Meter; there are no changes to other system testing components compared to the currently marketed product.
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
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
A meter equivalence study demonstrated that the OneTouch® Ultra® 2 Blood Glucose Monitoring System and the currently marketed OneTouch® Ultra® Blood Glucose Monitoring System are substantially equivalent.
Design verification (including software verification and validation testing) confirmed that the performance, safety and effectiveness of the OneTouch Ultra 2 Blood Glucose Monitoring System was equivalent with that of the predicate device.
The modified meter was tested in accordance with ISO 15197:2003(E) including a consumer evaluation to assess ease of use (human factors and user acceptance). In addition, reading level assessment of the product labeling was conducted and validated for comprehension.
Key Metrics
Not Found
Predicate Device(s)
OneTouch Ultra Blood Glucose Monitoring System (Ko2 4 194)
Reference Device(s)
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/0 description: The image shows the LifeScan logo, which includes a stylized globe and the company name in bold, sans-serif font. Below the company name, it says "a Johnson & Johnson company" in a smaller, italicized font. The logo has a swoosh design element above the company name, adding a dynamic visual element to the overall design. The logo is in black and white.
IAN 17
OneTouch® Ultra® 2 Blood Glucose Monitoring System
510(k) Summary
| Submitter | LifeScan, Inc.
1000 Gibraltar Drive
Milpitas, CA 95035-6312
Contact: Lisa McGrath
Date Prepared: December 16, 2005 |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | OneTouch® Ultra® 2 Blood Glucose Monitoring System
Common name: Glucose test system
Classification:
(1) OneTouch® Ultra® 2 Blood Glucose Meters and
OneTouch® Ultra® Test Strips are Class II devices (21
CFR § 862.1345)
(2) OneTouch® Ultra® Control Solution is a Class I
device (21 CFR § 862.1660)
(3) OneTouch® UltraSoft® Adjustable Blood Sampler and
Sterile Lancets are Class I (exempt) devices (21 CFR § |
System Description
The OneTouch Ultra 2 Blood Glucose Monitoring System consists of the OneTouch Ultra 2 Meter, OneTouch Ultra Test Strips (provided separately), OneTouch Ultra Control Solution, OneTouch UltraSoft Blood Sampler and OneTouch UltraSoft Sterile Lancets. The predicate OneTouch® Ultra® Meter has been modified to produce the OneTouch Ultra 2 Meter; there are no changes to other system testing components compared to the currently marketed product.
878.4800)
OneTouch Ultra Blood Glucose Monitoring System ( Ko2 4 194 ) Predicate Device
Intended Use
The OneTouch Ultra 2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra 2 System is intended for use 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 Ultra 2 Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
1
510(K) Summary, Page 2
Comparison to Predicate Device
The modifications to the device encompass meter software/firmware, ergonomic/physical design, hardware and labeling changes. There has been no change to the intended use, operating principle, functionality or material composition of the device.
Technological Characteristics
There has been no change to the fundamental scientific technology.
Summary of Performance Characteristics
There has been no change to the performance characteristics of the system.
A meter equivalence study demonstrated that the OneTouch® Ultra® 2 Blood Glucose Monitoring System and the currently marketed OneTouch® Ultra® Blood Glucose Monitoring System are substantially equivalent.
Design verification (including software verification and validation testing) confirmed that the performance, safety and effectiveness of the OneTouch Ultra 2 Blood Glucose Monitoring System was equivalent with that of the predicate device.
The modified meter was tested in accordance with ISO 15197:2003(E) including a consumer evaluation to assess ease of use (human factors and user acceptance). In addition, reading level assessment of the product labeling was conducted and validated for comprehension.
Conclusion
The modified OneTouch Ultra 2 Blood Glucose Monitoring System is substantially equivalent to the predicate OneTouch Ultra Blood Glucose Monitoring System.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, vectorized design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 7 2006
Ms. Lisa G. McGrath Regulatory Project Leader LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312
K053529 Re:
Trade/Device Name: OneTouch® Ultra® 2 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: December 17, 2005 Received: December 19, 2005
Dear: Ms. McGrath
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).
3
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) 276-0484. 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/industry/support/index.html.
Sincerely vours,
Alberto G. A.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K053529
Device Name: OneTouch® Ultra® 2 Blood Glucose Monitoring System
Indications For Use:
The OneTouch Ultra 2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra 2 System is intended for use 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 Ultra 2 Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
Prescription Use × (Part 21 CFR 801 Subpart D)
Image /page/4/Picture/7 description: The image shows the text "AND/OR" with the "AND" portion of the text circled. The text is written in a simple, sans-serif font. The circle around "AND" is hand-drawn and slightly irregular. The image appears to be a simple, possibly hand-drawn, graphic.
Over-The-Counter Use x (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Page 1 of 1
Albert Sevy
Division Sign-Off
Office of 1 a Vitro Diagnostic Device Evaluation and Salery
10(k) ........................................................................................................................................................................