PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST

K983504 · Medisense, Inc. · CGA · Jul 9, 1999 · Clinical Chemistry

Device Facts

• Record ID: K983504
• Device Name: PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST
• Applicant: Medisense, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jul 9, 1999
• Decision: SESE
• Submission Type: Traditional
• 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. for external use only) for the quantitative measurement of glucose and/or ketone in fresh capillary whole blood. The Precision Xtra is for home (lay user) or professional use. 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.

Device Story

Precision Xtra Advanced Diabetes Management System is a blood glucose and ketone monitoring system. It utilizes amperometric biosensor technology to measure glucose or Beta-Hydroxybutyrate levels in whole blood samples. The device generates an electrical current proportional to the analyte concentration, providing a quantitative result. It is designed for use by lay users in home settings or by healthcare professionals in clinical settings. The system provides immediate quantitative readouts, allowing users and clinicians to monitor glycemic status and ketone levels, facilitating diabetes management decisions.

Clinical Evidence

Performance evaluated in laboratory and clinical settings by healthcare professionals and lay users. Studies demonstrated that lay users obtain blood glucose and ketone results substantially equivalent to predicate methods. No specific sensitivity/specificity metrics provided in the summary.

Technological Characteristics

Amperometric biosensor technology. Measures current proportional to glucose or Beta-Hydroxybutyrate concentration. Quantitative measurement in whole blood and control solutions.

Indications for Use

Indicated for quantitative measurement of glucose and/or ketone in fresh capillary whole blood for home (lay user) or professional use. Also indicated for glucose measurement in venous, arterial, or neonatal whole blood and ketone measurement in venous blood (if used within 30 minutes).

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 (K963676)
• Precision QID® and Precision G® Blood Glucose Test Strip (K945887, K962295, K971812)
• GDS Stat-Site Meter/GDS KETOSITE® Blood Ketone Test (K911801)
• Sigma Diagnostics β-Hydroxybutyrate Procedure No. 310-UV (K850368)

Submission Summary (Full Text)

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Precision Xtra Advanced Diabetes Ma 510(k) Submission - 10/05

## Summary of Safety and Effectiveness

| Submitted by: | Denise Haley<br>Regulatory Affairs Specialist<br>MediSense, Inc.<br>4A Crosby Drive<br>Bedford, MA 01730 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Precision™ Xtra™ Advanced Diabetes Management System |
| Common Name: | Self-Monitoring Blood Glucose and Ketone System |
| Classification: | Glucose Test System<br>Class II per 21 CFR 862.1345<br>Ketones Test System<br>Class I per 21 CFR 862.1435 |
| Predicate Devices: | Precision QID® Blood Glucose Testing System--K963676<br>Precision QID® and Precision G® Blood Glucose Test Strip--<br>K945887, K962295, K971812<br>GDS Stat-Site Meter/GDS KETOSITE® Blood Ketone Test--<br>K911801<br>Sigma Diagnostics β-Hydroxybutyrate Procedure No. 310-UV--<br>K850368 |
| Description: | The Precision™ Xtra™ Advanced Diabetes Management System<br>for Blood Glucose and Ketone Testing utilizes amperometric<br>biosensor technology to generate a current. The size of the current<br>is proportional to the amount of glucose (or Beta-Hydroxybutyrate<br>ketone) present in the sample, providing a quantitative measure of<br>glucose (or ketone) in whole blood and control solutions. |
| Intended Use: | The Precision Xtra Advanced Diabetes Management System is<br>intended for in vitro diagnostic use (i.e. for external use only) for<br>the quantitative measurement of glucose and/or ketone in fresh<br>capillary whole blood. The Precision Xtra is for home (lay user) or<br>professional use. |

Medisense Confidential

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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.

# Comparison to

The Precision Xtra Advanced Diabetes Management System has Predicate Device: equivalent technological characteristics as the Precision QID Blood Glucose Testing System (K963676, K971812) and the Precision G Blood Glucose Testing System (K963676). The Precision Xtra also has the same intended use as the Precision OID and Precision G Systems for glucose testing and the GDS Ketosite Test Card on the GDS Stat-Site Meter(K911801) and Sigma B-Hydroxybutyrate Procedure 310-UV (K850368) for ketone testing.

#### Performance Studies:

The performance of the Precision Xtra Diabetes Management System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that lay users can obtain blood glucose and ketone results that are substantially equivalent to the current methods for blood glucose and ketone measurements, which include the predicate devices listed above.

Conclusion: Results of laboratory and clinical testing demonstrate that the performance of the Precision Xtra Advanced Diabetes Management 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 and ketone testing. In addition, results of clinical performance testing demonstrate that trained operators and lay users obtain equivalent whole blood glucose and ketone results.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 9 1999

Ms. Denise Haley Regulatory Affairs Specialist Abbott Laboratories MediSense Products 4A Crosby Drive Bedford, Massachusetts 01730-1402

Re: K983504

> Trade Name: Precision™ Xtra" Advanced Diabetes Management System Regulatory Class: II Product Code: CGA Dated: April 29, 1999 Received: May 3, 1999

Dear Ms. Haley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman

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

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### INDICATIONS FOR USE FORM

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. for external use only) for the quantitative measurement of glucose and/or ketone in fresh capillary whole blood. The Precision Xtra System is for home (lay user) or professional use.

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.

Dean Cooper
(Division Sign-Off)
Division of Clinical Laikrak
510(k) Number K983504

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

Prescription Use (Per 21 CFR 801.108) Over-The-Counter Use