MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM

K040814 · Abbott Laboratories · NBW · Apr 15, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040814
• Device Name: MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM
• Applicant: Abbott Laboratories
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 15, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Precision Xtra Advanced Diabetes Management 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 Xtra is also intended for the quantitative measurement of β-hydroxybutyrate (β-ketone) in fresh capillary whole blood. The Precision Xtra system is indicated for home (lay user) or professional use in the management of Patients with diabetes. The Precision Xtra System may also be used for the quantitative measurement of glucose in venous, arterial, or neonatal whole blood and ketone in venous blood, provided the sample is used within 30 minutes after collection.

Device Story

Precision Xtra Advanced Diabetes Management System uses amperometric biosensor technology to measure glucose or β-hydroxybutyrate (β-ketone) levels. Device accepts fresh capillary, venous, arterial, or neonatal whole blood samples. Biosensor generates electrical current proportional to analyte concentration; system converts current into quantitative blood glucose or ketone result. Used in home or professional clinical settings; operated by patients or healthcare providers. Output displayed to user for diabetes management; informs clinical decisions regarding glycemic control and ketone monitoring.

Clinical Evidence

Performance evaluated in laboratory and clinical settings by healthcare professionals and lay users. Studies demonstrated that lay users obtain blood glucose and β-ketone results substantially equivalent to current measurement methods.

Technological Characteristics

Blood glucose meter; fundamental scientific technology unchanged from predicate. Modification involves name change and test strip compatibility.

Indications for Use

Indicated for patients with diabetes (lay users or professionals) for quantitative measurement of glucose and β-hydroxybutyrate (β-ketone) in fresh capillary whole blood. Also indicated for glucose measurement in venous, arterial, or neonatal whole blood and ketone measurement in venous 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.

Predicate Devices

• Precision Xtra™ Advanced Diabetes Management System (K983504)

Submission Summary (Full Text)

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K040814

APR 1 5 2004

# (MediSense

## 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 Xtra™ Advanced Diabetes Management 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 Xtra™ Advanced Diabetes Management 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. |
| | Indications for Use: The Precision Xtra Advanced Diabetes Management System is intended<br>for in vitro diagnostic use (i.e., external use only) for the quantitative<br>measurement of glucose in fresh capillary whole blood. The Precision<br>Xtra is also intended for the quantitative measurement of β-<br>hydroxybutyrate (β-ketone) in fresh capillary whole blood. The Precision<br>Xtra system is indicated for home (lay user) or professional use in the<br>management of Patients with diabetes. |
| | The Precision Xtra System may also be used for the quantitative<br>measurement of glucose in venous, arterial, or neonatal whole blood and<br>ketone in venous blood, provided the sample is used within 30 minutes<br>after collection. |

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| Comparison to<br>Predicate Device: | The modified Precision Xtra™ Advanced Diabetes Monitoring System<br>uses the same fundamental scientific technology and has the same<br>intended use as the predicate Precision Xtra Advanced Diabetes<br>Management System (K983504). |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Studies: | The performance of the Precision Xtra Diabetes Monitoring System was<br>studied in the laboratory and in clinical settings by healthcare<br>professionals and lay users. The studies demonstrated that lay users can<br>obtain blood glucose and blood β-Ketone results that are substantially<br>equivalent to the current methods for blood glucose and blood β-ketone<br>measurements. |
| Conclusion: | Results of laboratory and clinical testing demonstrate that the<br>performance of the Precision Xtra Diabetes Monitoring System, when<br>used according to the intended use stated above, is acceptable and<br>comparable to the performance of the previously mentioned predicate<br>device for blood glucose and blood β-ketone testing. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

# APR1 5 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

k040814 Re:

Trade/Device Name: Precision Xtra™ Advanced Diabetes Management System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, LFR, JIN Dated: March 29, 2004 Received: March 30, 2004

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 equivalcnt (for the indications for use stated in the enclosurc) to legally marketed predicate devices marketed in interstatc 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). You may obtain other general information on your responsibilities under the Act 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,

Seain M. Cooper, US, DVM.

Jean M. Cooper, MS, D.V.M. 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):

Device Name:

Precision Xtra " Advanced Diabetes Management System

Indications For Use:

The Precision Xtra Advanced Diabetes Management 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 Xtra is also intended for the quantitative measurement of ß-hydroxybutyrate (ßketone) in fresh capillary whole blood. The Precision Xtra system is indicated for home (lay user) or professional use in the management of Patients with diabetes.

The Precision Xtra System may also be used for the quantitative measurement of glucose in venous, arterial, or neonatal whole blood and ketone in venous blood, provided the sample is used within 30 minutes after collection.

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

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

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

Carol Benn
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040814

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