(31 days)
Not Found
Not Found
No
The summary describes a standard glucose meter with a minor labeling modification and contains no mention of AI or ML.
No
The device is described as a meter for quantitative measurement of glucose, aiding in monitoring diabetes management, not directly treating or curing a condition.
Yes
The device is described as measuring glucose in whole blood "as an aid in monitoring effectiveness of diabetes management," which indicates a diagnostic purpose.
No
The device description explicitly refers to a "meter," which is a hardware component used for measuring glucose. The modification described relates to the labeling for this hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in whole blood." This involves testing a biological sample (whole blood) outside of the body (in vitro).
- Purpose: The purpose is to aid in "monitoring effectiveness of diabetes management," which is a diagnostic purpose related to a medical condition.
- Device Type: Glucose meters are a common example of IVD devices.
The other sections of the provided text, while relevant to the device's regulatory information, don't contradict its classification as an IVD. The modification to the labeling and the lack of information on image processing, AI, etc., are details about the device itself and its development, not its fundamental nature as a diagnostic tool used on a biological sample.
N/A
Intended Use / Indications for Use
The ONETOUCH® Profile Meter is used for the quantitative determination of glucose in whole blood by lay persons in the home and by medical professionals in clinical settings as an aid in monitoring effectiveness of diabetes management.
Product codes
CGA
Device Description
The labeling of this device was modified to enhance instructions for use advising users to insure the display is operating properly each time they perform a test.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
lay persons in the home and by medical professionals in clinical settings
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
'JUN 2 8 2002
510(k) SUMMARY
.
(As required by 21 C.F.R. § 807.92)
| Submitted By: | Lifescan, Inc.
1000 Gibraltar Drive
Milpitas, CA 95035 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John E. Hughes
Phone: 408-942-5903
Fax: 408-942-5906 |
| Date Summary
Prepared: | June 20, 2002 |
| Device Name | ONETOUCH® Profile Meter |
| Classification | 862.1345 Glucose Test System |
| Description of the
Changed Labeling | The labeling of this device was modified to enhance instructions for
use advising users to insure the display is operating properly each
time they perform a test. |
| Statement of
Intended Use: | The ONETOUCH Profile Meter is used for the quantitative
determination of glucose in whole blood by lay persons in the home
and by medical professionals in clinical settings as an aid in
monitoring effectiveness of diabetes management. |
| Substantial
Equivalence: | The current labeling for this meter advises users to check that the
display is operating properly. The revised labeling clarifies that the
user should check the display integrity each time a test is
performed. |
1
Image /page/1/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 three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 8 2002
Mr. John E. Hughes Manager Regulatory Submissions LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312
K021943 Re:
Trade/Device Name: OneTouch® Profile Meter Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA Dated: May 24, 2002 Received: May 28, 2002
Dear Mr. Hughes:
We have reviewed vour 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsmaldsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number:
ONETOUCH® Profile Meter Device Name:
Indications for Use:
The ONETOUCH® Profile Meter is used for the quantitative measurement of glucose in whole blood by lay persons in the home and by medical professionals in clinical settings as an aid in monitoring effectiveness of diabetes management.
Hap Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021943
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use