PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO

K023256 · Abbott Laboratories · NBW · Apr 23, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023256
• Device Name: PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO
• Applicant: Abbott Laboratories
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

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.

Device Story

Amperometric biosensor test strip; measures glucose in fresh whole blood or control solutions. Principle: current generation proportional to glucose concentration. Used by patients (self-testing) or healthcare professionals in clinical/home settings. Provides quantitative blood glucose readings to assist in diabetes management. Enables testing at alternative sites (forearm, upper arm, base of thumb) in addition to fingertip.

Clinical Evidence

Laboratory and clinical studies conducted with lay users and healthcare professionals. Results demonstrated that lay users obtain blood glucose measurements substantially equivalent to the predicate device and current standard methods. Testing confirmed performance is acceptable for steady-state blood glucose monitoring across all indicated sampling sites.

Technological Characteristics

Amperometric biosensor technology. Quantitative measurement of glucose via current generation. Form factor: test strip. Intended for in-vitro diagnostic use.

Indications for Use

Indicated for quantitative glucose measurement in fresh whole blood for diabetes management and other conditions. Suitable for self-testing by lay users or use by healthcare professionals. Samples may be obtained from the fingertip, forearm, upper arm, or base of thumb.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Precision Xtra® Blood Glucose Testing System (K010553)

Submission Summary (Full Text)

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K023256

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<br>Sr. Regulatory Affairs Specialist<br>Abbott Laboratories, MediSense Products<br>4A Crosby Drive<br>Bedford, MA 01730-6230 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Precision Xtra / MediSense Optium / Precision Easy / MediSense<br>Optium Easy Blood Glucose Test Strip with True Measure Technology |
| Common Name: | Self-Monitoring Blood Glucose System |
| Classification: | Glucose Test System<br>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<br>biosensor technology to generate a current. The size of the current is<br>proportional to the amount of glucose present in the sample, providing<br>a quantitative measure of glucose in whole blood and control solutions. |
| Intended Use: | The test strip is intended for outside-the-body ( <i>in-vitro</i> diagnostic) use.<br>The system is indicated for the quantitative measurement of glucose in<br>fresh whole blood for self-testing by lay users (e.g., from the finger,<br>forearm, upper arm or base of thumb), or by health care professionals.<br>The test strip is to be used for monitoring blood glucose concentrations<br>in persons with diabetes and other conditions. |
| Comparison to<br>Predicate Device: | The test strip has equivalent technological characteristics as the<br>Precision Xtra Blood Glucose Test Strip (K010553). The test strip has<br>the same intended use as the original test strip with the addition of<br>forearm, upper arm and base of thumb. |
| Performance<br>Studies: | The performance of the test strip was studied in the laboratory and in<br>clinical settings by healthcare professionals and lay users. The studies<br>demonstrated that lay users can obtain blood glucose results that are<br>substantially equivalent to the current methods for blood glucose<br>measurements, which include the predicate device listed above. The<br>performance studies also demonstrate that testing blood glucose<br>concentrations, during a steady state, are substantially equivalent. |

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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.

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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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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 [phone]. 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 [phone] or [phone] 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

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