PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS

K051213 · Abbott Laboratories, Inc. · NBW · May 27, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051213
• Device Name: PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
• Applicant: Abbott Laboratories, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 27, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

Blood Glucose Test Strips are intended for in-vitro diagnostic use in 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

Precision Xtra Advanced Diabetes Management System uses amperometric biosensor technology; test strips accept fresh capillary blood samples. Biosensor generates electrical current proportional to glucose concentration in sample. Quantitative glucose measurement output displayed to user. Used by patients (self-testing) or healthcare professionals in clinical or home settings. Output allows monitoring of blood glucose levels to assist in diabetes management.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control procedures (21 CFR 820.30) to assess impact of modifications (strip color, sample volume, assay time). Results demonstrated predetermined acceptance criteria were met.

Technological Characteristics

In vitro diagnostic test strip; modified for background color, reduced sample volume, assay time, and second sample application timing. Fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary blood for self-testing by lay users (finger, forearm, upper arm, base of thumb) or healthcare professionals to monitor blood glucose concentrations in persons with diabetes and other conditions.

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.

Submission Summary (Full Text)

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K051213

Abbott Laboratories Blood Glucose Test Strips MAY 2 7 2005

Special 510(k) May 11, 2005

# Attachment 4

## 510(k) Summary

Per 21 CFR §807.92

| Company | Abbott Laboratories |
|------------------------|----------------------------------------------------------------------------|
| Division | Abbott Diabetes Care |
| Street Address | 1360 South Loop Road |
| City, State Zip | Alameda, CA 94502 |
| Phone | 510-749-6360 |
| Contact Person: | Andrea L. Ruth<br>510-749-6360<br>[e-mail] |
| Proprietary Name: | MediSense Optium Plus and Precision Xtra Plus<br>Blood Glucose Test Strips |
| Common Name: | Blood Glucose Test Strips |
| Classification Number: | 21 CFR §862.1345 |
| Predicate Device: | MediSense Optium Plus and Precision Xtra Plus<br>Blood Glucose Test Strips |
| Date Prepared: | May 11, 2005 |

#### Description of the Device:

The Precision Xtra™ Advanced Diabetes Management System 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 of the Device:

Blood Glucose Test Strips are intended for in-vitro diagnostic use in 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.

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# Comparison to Predicate Device:

| | Predicate Device | Subject (modified)<br>Device |
|------------------------|----------------------------------------------------------------------------|------------------------------|
| Company | Abbott Laboratories | Same |
| Division | Abbott Diabetes Care | Same |
| 510(k) Reference | K023256 | Current Submission |
| Proprietary Name: | MediSense Optium Plus and Precision<br>Xtra Plus Blood Glucose Test Strips | Same |
| Common Name: | Blood Glucose Test Strips | Same |
| Classification Number: | 21 CFR §862.1345 | Same |
| Intended Use | Quantitative measurement of blood<br>glucose concentrations | Same |
| Single Use? | Yes, test strips are single use | Same |
| Sterilized? | No | Same |

# Performance Studies:

The performance of the strips using various diabetes monitoring systems was studied in the laboratory. The studies demonstrated that lay users can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements.

#### Conclusion:

Results of laboratory testing demonstrate that the performance of the Precision Xtra Diabetes Test Strip is acceptable and comparable to the performance of the predicate device for blood glucose testing, when used according to its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Andrea L. Ruth, RAC Senior Associate, Regulatory Affairs Abbott Laboratories TheraSense, Inc. 1360 South Loop Road Alameda, CA 94502

MAY 2 7 2005

k051213 Re:

KUST213
Trade/Device Name: Optium Plus Blood Glucose Test Strips and Optiali Prava Plus Blood Glucose Test Strips Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: LFR, NBW Dated: May 11, 2005 Received: May 17, 2005

Dear Ms. Ruth:

We have reviewed your Section 510(k) premarket notification of intent to market the devices We have reviewed your Section 510(x) prematice is substantially equivalent (for the indications referenced and nave determined the actrice the actives marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices Amendments, o for use stated in the encrosure) to regary manteed pevice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Edgers Food Drug commerce prior to May 28, 1970, the enastinent with the provisions of the Federal Food, Drug, devices that have been recialsmed in accordance will of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ap and Cosment Act (Act) that to not require approvince approvisions of the Act. The Act. The Act. The You may, merelore, market the device, baojoer to the go
general controls provisions of the Act include requirements for annual registration, listing of the general controls provisions of the Fectively required of childitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (SCC above) into entirely major regulations affecting your device it may be subject to such additional controls. Blasting may of the only of the subservations of the subject to can be found in Thic 21, Coub of Peachartogan device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA \$ issualites of a substaints with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA nas made a delemination that your are roo sompler Federal agencies. You must or any Federal statutes and regulations administered of called to: registration and listing (21
comply with all the Act's requirements, including, but not limited to: registr comply with an the Act 3 requirements, intractly); and good manufacturing practice CFR Part 807), labening (21 CFR Parts 601 and 607), and States (QS) regulation (21 CFR Part 820).

Image /page/2/Picture/11 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter.

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#### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) This icity wifi anow you to begin mainer of substantial equivalence of your device to a legally premarket nothroation: "The PDF Interlassification 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 of quostions on the prome Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I bu may other general michinational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benem

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K051213

Optium Plus Blood Glucose Test Strips and Device Name: Precision Xtra Plus Blood Glucose Test Strips

The Precision Xtra / MediSense Optium / Precision Easy / Indications For Use: MediSense Optium Easy Blood Glucose Test Strip is intended for outside-the-body (in-vitro diagnostic) use. The strip is indicated for the quantitative measurement of glucose in fresh capillary 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

V

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Rutta Chaber

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Stolk K051213

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