(205 days)
Not Found
No
The description focuses on amperometric biosensor technology and does not mention AI or ML.
No
This device is a diagnostic tool used for monitoring blood glucose levels, not for treating or preventing disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "in-vitro diagnostic use" and indicates its purpose for "monitoring blood glucose concentrations in persons with diabetes and other conditions," which is a diagnostic activity.
No
The device description explicitly states it is a "test strip" that utilizes "amperometric biosensor technology" to generate a current, indicating it is a physical hardware component for in-vitro diagnostic use.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Precision Xtra / MediSense Optium / Precision Easy / MediSense Optium Easy Blood Glucose Test Strip is intended for outside-of-the-body (in-vitro diagnostic) use."
N/A
Intended Use / Indications for Use
The test strip is intended for outside-the-body (in-vitro diagnostic) use. The system is indicated for the quantitative measurement of glucose in fresh whole blood for self-testing by lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals. The test strip is to be used for monitoring blood glucose concentrations in persons with diabetes and other conditions.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR
Device Description
The test strip is for blood glucose testing utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measure of glucose in whole blood and control solutions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger, forearm, upper arm or base of thumb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals.
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)
The performance of the test strip was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that lay users can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements, which include the predicate device listed above. The performance studies also demonstrate that testing blood glucose concentrations, during a steady state, are substantially equivalent. Results of laboratory and clinical testing demonstrate that the performance of the test strip, when used according to the intended use stated above, is acceptable and comparable to the performance of the previously mentioned predicate device for blood glucose testing. In addition, results of clinical performance testing demonstrate that trained operators and lay users obtain equivalent whole blood glucose results.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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APR 2 3 2003
Precision Xtra/MediSense Optium Blood Glucose Test Strip
510(K) SUMMARY As Required By 21 CFR 807.92
| Submitted by: | Janet Connolly, RAC
Sr. Regulatory Affairs Specialist
Abbott Laboratories, MediSense Products
4A Crosby Drive
Bedford, MA 01730-6230 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Precision Xtra / MediSense Optium / Precision Easy / MediSense
Optium Easy Blood Glucose Test Strip with True Measure Technology |
| Common Name: | Self-Monitoring Blood Glucose System |
| Classification: | Glucose Test System
Class II per 21 CFR 862.1345 |
| Predicate Device: | Precision Xtra® Blood Glucose Testing System, K010553 |
| Description: | The test strip is for blood glucose testing utilizes amperometric
biosensor technology to generate a current. The size of the current is
proportional to the amount of glucose present in the sample, providing
a quantitative measure of glucose in whole blood and control solutions. |
| Intended Use: | The test strip is intended for outside-the-body ( in-vitro diagnostic) use.
The system is indicated for the quantitative measurement of glucose in
fresh whole blood for self-testing by lay users (e.g., from the finger,
forearm, upper arm or base of thumb), or by health care professionals.
The test strip is to be used for monitoring blood glucose concentrations
in persons with diabetes and other conditions. |
| Comparison to
Predicate Device: | The test strip has equivalent technological characteristics as the
Precision Xtra Blood Glucose Test Strip (K010553). The test strip has
the same intended use as the original test strip with the addition of
forearm, upper arm and base of thumb. |
| Performance
Studies: | The performance of the test strip was studied in the laboratory and in
clinical settings by healthcare professionals and lay users. The studies
demonstrated that lay users can obtain blood glucose results that are
substantially equivalent to the current methods for blood glucose
measurements, which include the predicate device listed above. The
performance studies also demonstrate that testing blood glucose
concentrations, during a steady state, are substantially equivalent. |
1
between the fingertip and alternative sites (i.e. forearm, upper arm or base of thumb).
Conclusion: Results of laboratory and clinical testing demonstrate that the performance of the test strip, when used according to the intended use stated above, is acceptable and comparable to the performance of the previously mentioned predicate device for blood glucose testing. In addition, results of clinical performance testing demonstrate that trained operators and lay users obtain equivalent whole blood glucose results.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized image of an eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)".
APR 2 3 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Janet Connolly, RAC Senior Regulatory Submissions Specialist Abbott Laboratories MediSense Products 4A Crosby Drive Bedford, MA 01730
Re: K023256
Trade/Device Name: Preision® Xtra® /MediSense® Optium™ Blood Glucose Test Strip with True Measure Technology Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, LFR Dated: January 23, 2003 Received: January 24, 2003
Dear Ms. Connolly:
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE FORM
Ko23356 510(k) Number (if known):
Precision® Xtra® / MediSense® Optium™ Blood Glucose Test Strip Device Name: with True Measure Technology
Precision® Easy / MediSense® Optium™ Easy Blood Glucose Test Strip with True Measure Technology
Indications For Use:
The Precision Xtra / MediSense Optium / Precision Easy / MediSense Optium Easy Blood Glucose Test Strip is intended for outside-the-body (in-vitro diagnostic) use. The system is indicated for the quantitative measurement of glucose in fresh whole blood for self-testing by lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals. The test strip is to be used for monitoring blood glucose concentrations in persons with diabetes and other conditions.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.108) Over-The-Counter Use
. .
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023256
or