(28 days)
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Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components. The modifications are related to the physical size of the device and lancing device, and the performance studies focus on equivalence to a predicate device and adherence to ISO standards for accuracy and usability.
No.
This device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, which aids in diabetes management by providing information, but it does not directly treat or prevent a disease.
Yes
This device is a diagnostic device because its intended use is for the quantitative measurement of glucose in fresh capillary whole blood, and it explicitly states it is for "in vitro diagnostic use" as an aid to monitor the effectiveness of diabetes control.
No
The device description explicitly lists hardware components like the meter, test strips, control solution, lancing device, and lancets, indicating it is a hardware-based system with software as part of the system.
Yes, the provided text explicitly states that the OneTouch UltraMini Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section clearly says:
The OneTouch UltraMini 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.
N/A
Intended Use / Indications for Use
The OneTouch UltraMini Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch UltraMini 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 UltraMini Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
Product codes
NBW
Device Description
The OneTouch UltraMini Blood Glucose Monitoring System consists of the OneTouch UltraMini Meter, OneTouch Ultra Test Strips (provided separately), OneTouch Ultra Control Solution, OneTouch Lancing Device with AST Clear Cap or OneTouch UltraSoft Blood Sampler with OneTouch UltraClear Cap and OneTouch UltraSoft Sterile Lancets. The predicate OneTouch® Ultra® Meter has been modified to produce the OneTouch UltraMini Meter. The OneTouch Lancing Device with AST Clear Cap is a modification (smaller size) of the existing OneTouch UltraSoft Blood Sampler with OneTouch UltraClear Cap (class I, exempt device). There are no changes to any of the other system testing components compared to the currently marketed product.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
finger, forearm or palm
Indicated Patient Age Range
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
A meter equivalence study demonstrated that the OneTouch UltraMini 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 UltraMini Blood Glucose Monitoring System were equivalent with that of the predicate device.
The modified meter was tested in accordance with ISO 15197:2003(E) including System Accuracy, Clinical Accuracy, and 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
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Predicate Device(s)
OneTouch Ultra Blood Glucose Monitoring System
Reference Device(s)
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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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Image /page/0/Picture/1 description: The image shows the LifeScan logo. The logo features the word "LIFESCAN" in bold, sans-serif font, with the tagline "a Johnson & Johnson company" in a smaller, more delicate font underneath. To the left of the wordmark is a stylized graphic element that resembles a sphere with an orbital path around it.
19 3000
OneTouch® UltraMini™ Blood Glucose Monitoring System
510(k) Summarv
Submitter
LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312
510(k) Contact Name: Mary Ellen Holden, Regulatory Project Leader. LifeScan. Inc. (408) 942-3589 or E-Mail: Mholden@lfsus.jni.com
510(k) Prepared by: Alison Wilson, Regulatory Specialist, LifeScan Scotland Limited
OneTouch® UltraMini™ Blood Glucose Monitoring System Common name: Glucose test system
Classification:
- (1) OneTouch® UltraMini™ 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® Lancing Device with ASTTM Clear Cap, OneTouch® UltraSoft® Adjustable Blood Sampler with OneTouch® UltraClear® Cap and OneTouch® UltraSoft® Sterile Lancets are Class I (exempt) devices (21 CFR § 878.4800)
System Description
The OneTouch UltraMini Blood Glucose Monitoring System consists of the OneTouch UltraMini Meter, OneTouch Ultra Test Strips (provided separately), OneTouch Ultra Control Solution, OneTouch Lancing Device with AST Clear Cap or OneTouch UltraSoft Blood Sampler with OneTouch UltraClear Cap and OneTouch UltraSoft Sterile Lancets. The predicate OneTouch® Ultra® Meter has been modified to produce the OneTouch UltraMini Meter. The OneTouch Lancing Device with AST Clear Cap is a modification (smaller size) of the existing OneTouch UltraSoft Blood Sampler with OneTouch UltraClear Cap (class I, exempt device). There are no changes to any of the other system testing components compared to the currently marketed product.
Predicate Device
OneTouch Ultra Blood Glucose Monitoring System
Device Name
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Image /page/1/Picture/0 description: The image shows the LifeScan logo, which includes the company name in bold, sans-serif font. Above the name is a curved line that starts with a globe-like shape on the left. Below the name, in a smaller font, is the text "a Johnson & Johnson company." The logo is simple and professional, conveying a sense of trust and reliability.
510(K) Summary, Page 2
Intended Use
The OneTouch UltraMini Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch UltraMini 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 UltraMini Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
Comparison to Predicate Device
The modifications to the device encompass meter ergonomic/physical design, electronic/hardware, software/firmware and labeling changes. There has been no change to the intended use, fundamental scientific technology, operating principle, or essential functionality 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 UltraMini 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 UltraMini Blood Glucose Monitoring System were equivalent with that of the predicate device.
The modified meter was tested in accordance with ISO 15197:2003(E) including System Accuracy, Clinical Accuracy, and 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 UltraMini Blood Glucose Monitoring System is substantially equivalent to the predicate OneTouch Ultra Blood Glucose Monitoring System.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows a logo for the Department of Health & Human Services, USA. The logo features a stylized human figure with three arms reaching upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the figure.
September 2017 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 19 2006
LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312 Attn: Mary Ellen Holden, Regulatory Project Leader
Re: K061118
Trade/Device Name: One-Touch® UltraMini™ Blood Glucose Monitoring System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: April 20, 2006 Received: April 21, 2006
Dear Ms. Holden:
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. Iisting 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) 276-0484. 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 yours,
Alberto G
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
510(k) Number (if known): KOG // /8
Device Name: OneTouch® UltraMini™ Blood Glucose Monitoring System
一十八年八月十八月月1日 1972年 1978年 1997 1997 1997 1997 1994 1994 1994 1994 1994 1994 1994 1994 1994 1994 1994 1994 1994 1994 1994 1994 1994 1994 1994 1994 1999 1999
Indications For Use:
The OneTouch UltraMini Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch UltraMini 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 UltraMini Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.
t 21 CFR 801 Subpart D)
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he-Counter Use (21 CFR 801 Subpart C)
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(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
Carol C. Benson
Office of In Vitro Diagnostic Device Evaluation and Safety
11000 K061118