MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM

K022182 · Abbott Laboratories · NBW · Sep 9, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022182
• Device Name: MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Abbott Laboratories
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System 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), or by health care professionals. The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System is to be used for the monitoring of blood glucose concentrations in persons with diabetes and other conditions.

Device Story

System utilizes amperometric biosensor technology to measure blood glucose; device accepts fresh whole blood samples; biosensor generates electrical current proportional to glucose concentration; system provides quantitative glucose measurement; used by lay users for self-testing or by healthcare professionals in clinical settings; output allows users and providers to monitor glucose concentrations for diabetes management.

Clinical Evidence

Performance evaluated in laboratory and clinical settings involving both healthcare professionals and lay users. Studies demonstrated that lay users obtain blood glucose results substantially equivalent to current methods and comparable to predicate device performance.

Technological Characteristics

Amperometric biosensor technology; quantitative measurement via current generation proportional to glucose concentration; in-vitro diagnostic system; Class II device per 21 CFR 862.1345.

Indications for Use

Indicated for quantitative blood glucose measurement in fresh whole blood for individuals with diabetes or other conditions requiring glucose monitoring. Suitable for self-testing by lay users (fingerstick) or use by healthcare professionals.

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 QID Blood Glucose Testing System (K944195, K971812)

Submission Summary (Full Text)

{0}------------------------------------------------

821

## 9 2002 SEP

## SUMMARY OF SAFETY AND EFFECTIVENESS

| 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: | MediSense® Precision® Easy / MediSense® OptiumTM Easy Blood<br>Glucose Monitoring System |
| Common Name: | Self-Monitoring Blood Glucose System |
| Classification: | Glucose Test System<br>Class II per 21 CFR 862.1345 |
| Predicate Device: | Precision QID® Blood Glucose Testing System, K944195, K971812, |
| Description: | The MediSense Precision Easy / MediSense Optium Easy Blood<br>Glucose Monitoring System for blood glucose testing utilizes<br>amperometric biosensor technology to generate a current. The size of<br>the current is proportional to the amount of glucose present in the<br>sample, providing a quantitative measure of glucose in whole blood<br>and control solutions. |
| Intended Use: | The MediSense Precision Easy / MediSense Optium Easy Blood<br>Glucose Monitoring System is intended for outside-the-body (in-vitro<br>diagnostic) use. The system is indicated for the quantitative<br>measurement of glucose in fresh whole blood for self-testing by lay<br>users (e.g., from the finger), or by health care professionals. |
| Comparison to<br>Predicate Device: | The MediSense Precision Easy / MediSense Optium Easy Blood<br>Glucose Monitoring System has equivalent technological<br>characteristics as the Precision QID Blood Glucose Testing System<br>(K944195, K971812). The Precision Easy also has the same intended<br>use as the Precision QID. |
| Performance<br>Studies: | The performance of the MediSense Precision Easy / MediSense<br>Optium Easy Blood Glucose Monitoring System was studied in the<br>laboratory and in clinical settings by healthcare professionals and lay<br>users. The studies demonstrated that lay users can obtain blood<br>glucose results that are substantially equivalent to the current methods |

Abbott Laboratories Inc., MediSense Products

{1}------------------------------------------------

for blood glucose measurements, which include the predicate devices listed above.

- Results of laboratory and clinical testing demonstrate that the Conclusion: performance of the MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System, when used according to the intended use stated above, is acceptable and comparable to the performance of the previously mentioned predicate devices 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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three arms or branches extending upwards.

## 9 2002 SEP

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Janet Connolly, RAC Sr. Regulatory Affairs Specialist Abbott Laboratories, MediSense Products 4A Crosby Drive Bedford, MA 01730-1402

k022182 Re:

> Trade/Device Name: MediSense® Precision® Easy/MediSense® Optium™ Easy Blood Glucose Monitoring System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 2, 2002 Received: July 3, 2002

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 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

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

{4}------------------------------------------------

## INDICATIONS FOR USE FORM

510(k) Number (if known): K022182

Device Name:

MediSense® Precision® Easy / MediSense® Optium™ Easy Blood Glucose Monitoring System

Indications For Use:

The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System 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 selftesting by lay users (e.g., from the finger), or by health care professionals. The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System is to be used for the monitoring of blood glucose concentrations in persons with diabetes and other conditions.

Han

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022182
Cooph

(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) or

Over-The-Counter Use

er Use V

Lian Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices i 510(k) Number_ ( ( 2 ) 2 ) 2 2 2