PRECISION XCEED DIABETES MONITORING SYSTEM

K033845 · Abbott Laboratories · NBW · Jan 8, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033845
• Device Name: PRECISION XCEED DIABETES MONITORING SYSTEM
• Applicant: Abbott Laboratories
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 8, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Precision® Xceed™ Diabetes Monitoring System is intended for in vitro diagnostic use (i.e., external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Precision Xceed is also intended for the quantitative measurement of β-hydroxybutyrate (β-ketone) in fresh capillary whole blood. The Precision Xceed system is indicated for home (lay user) or professional use.

Device Story

System uses amperometric biosensor technology to measure glucose or β-hydroxybutyrate (β-ketone) in fresh capillary whole blood; device generates electrical current proportional to analyte concentration; provides quantitative results; used by lay users at home or by professionals in clinical settings; assists in diabetes management; results inform clinical decision-making.

Clinical Evidence

No clinical data; bench testing and design verification/validation performed per 21 CFR 820.30.

Technological Characteristics

Electronic components, external case, symbol-based display interface. Fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for home (lay user) or professional use for quantitative measurement of glucose and β-hydroxybutyrate (β-ketone) in fresh capillary whole blood.

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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K033845

JAN - 8 2004

Image /page/0/Picture/2 description: The image shows the word "MediSense" in a bold, sans-serif font. A curved line appears above the word, starting from the left and extending over the "M" and part of the "e". A registered trademark symbol is located to the upper right of the word.

Precision Xceed Diabetes Monitoring System Special 510(k) Submission

## 510(k) Summary

(as required by 21 CFR 807.92)

| Submitted by: | Tracey H. Wielinski RAC<br>Strategic Quality Assurance and Regulatory Affairs Manager<br>Abbott Laboratories, MediSense Products<br>4A Crosby Drive<br>Bedford, MA 01730 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Precision® Xceed™ Diabetes Monitoring System |
| Common Name: | Whole Blood Glucose and Ketone Test System |
| Classification: | Glucose Test System<br>Class II per 21 CFR 862.1345 |
| | Ketone Test System<br>Class I per 21 CFR 862.1435 |
| Product Code: | NBW, LFR, JIN |
| Predicate Device: | Precision Xtra® Advanced Diabetes Management System, K983504 |
| Description: | The Precision® Xceed™ Diabetes Monitoring System utilizes<br>amperometric biosensor technology to generate a current. The size of the<br>current is proportional to the amount of glucose or β-hydroxybutytate (β-<br>ketone) present in the sample, providing a quantitative measure of<br>glucose or β-ketone in whole blood and control solutions. |
| Intended Use: | The Precision® Xceed™ Diabetes Monitoring System is intended for in<br>vitro diagnostic use (i.e., external use only) for the quantitative<br>measurement of glucose in fresh capillary whole blood. The Precision<br>Xceed is also intended for the quantitative measurement of β-<br>hydroxybutyrate (β-ketone) in fresh capillary whole blood. The Precision<br>Xceed system is indicated for home (lay user) or professional use. |
| Comparison to<br>Predicate Device: | The Precision® Xceed™ Diabetes Monitoring System uses the same<br>fundamental scientific technology and has the same intended use as the<br>predicate Precision Xtra Advanced Diabetes Management System<br>(K983504). |

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#### Performance The performance of the Precision Xceed Diabetes Monitoring System Studies: was studied in the laboratory and in clinical settings by healthcare was otadiou in the studies demonstrated that lay users can obtain blood glucose and ß-Ketone results that are substantially equivalent to the current methods for blood glucose and ß-ketone measurements. Results of laboratory and clinical testing demonstrate that the Conclusion: Rooms of the Precision Xceed Diabetes Monitoring System, 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 and ß-ketone testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. Inside the circle is a stylized symbol that resembles a human figure embracing another, or possibly a bird in flight, represented by a series of curved lines.

Public Health Service

### JAN - 8 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Tracey H. Wielinski, RAC Strategic Quality Assurance and Regulatory Affairs Manager Abbott Laboratories MediSense Products 4A Crosby Drive Bedford, MA 01730-1402

Re: k033845

R055645
Trade/Device Name: Precision® Xceed™ Diabetes Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, JKF, LFR Dated: December 10, 2003 Received: December 11, 2003

Dear Ms. Wielinski:

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 Butman

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

| 510(k) Number (if known): | K033845 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Precision® Xceed™ Diabetes Monitoring System |
| Indications For Use: | The Precision Xceed Diabetes Monitoring System is<br>intended for <i>in vitro</i> diagnostic use (i.e. external use only)<br>for the quantitative measurement of glucose in fresh<br>capillary whole blood. The Precision Xceed is also<br>intended for the quantitative measurement of β-<br>hydroxybutyrate (β-ketone) in fresh capillary whole blood.<br>The Precision Xceed system is indicated for home (lay<br>user) or professional use. |

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

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

X

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

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

Carol C Benson

Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033845