PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP

K971812 · Medisense, Inc. · CGA · Aug 8, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971812
• Device Name: PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP
• Applicant: Medisense, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Aug 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Precision QID Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. For home or professional use with the Precision QID Blood Glucose Sensor. Compatible with the MediSense 2 Card and Pen Blood Glucose Sensors, and the Companion 2 Card and Pen Blood Glucose Sensors. The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial, or neonate whole blood, provided the sample is used within 30 minutes of collection. The Precision G Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh whole capillary blood. The Precision G Blood Glucose Testing System is intended for home or professional use.

Device Story

Precision QID and Precision G Blood Glucose Test Strips utilize amperometric biosensor technology to measure glucose levels in whole blood and control solutions. Strips are used with compatible MediSense testing systems. Operation involves applying a blood sample to the test strip; the biosensor generates an electrical current proportional to the glucose concentration. Results are displayed on the compatible meter for patient or clinician review. Used in home or professional clinical settings to monitor blood glucose levels, aiding in diabetes management. The system provides quantitative data to inform clinical decision-making regarding glycemic control.

Clinical Evidence

Performance evaluated via laboratory and clinical studies involving both healthcare professionals and lay users. Results demonstrated that users obtain blood glucose measurements substantially equivalent to predicate devices and current standard methods.

Technological Characteristics

Amperometric biosensor technology. Test strips are designed for quantitative glucose measurement in whole blood. Compatible with specific MediSense meter systems. No specific materials or software architecture details provided.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood for home or professional use. Healthcare professionals may also use the Precision QID system for venous, arterial, or neonate whole blood samples (within 30 minutes of collection).

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 Test Strip (K945887, K962295)
• Precision G Blood Glucose Testing System (K963676)
• Accu-Chek Advantage Test Strips (K951887, K954833)

Submission Summary (Full Text)

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AUG - 8 1997

1971812

## Summary of Safety and Effectiveness

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| Submitted by: | Michael Halpin<br>Manager of Regulatory Affairs<br>MediSense, Inc.<br>4A Crosby Drive<br>Bedford MA 01730 |
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| Device Name: | Precision QID® and Precision G Blood Glucose Test Strip |
| Common Name: | Reagent test strips for Blood Glucose |
| Classification: | "Glucose Test System" - Class II per CFR 862.1345 |
| Predicate Devices: | Precision QID® Blood Glucose Test Strip - K945887, K962295<br>Precision G Blood Glucose Testing System - K963676<br>Accu-Chek Advantage Test Strips - K951887, K954833 |
| Description: | The Precision QID and Precision G Blood Glucose Test Strips are<br>identical in test strip design. Both test strips utilize amperometric<br>biosensor technology to quantitatively measure glucose in whole blood<br>and control solutions. The Precision QID Blood Glucose Test Strips<br>are for use with the Precision QID Blood Glucose Testing System and<br>are also compatible with the MediSense 2 Card and Pen Blood Glucose<br>Testing Systems. The Precision G Blood Glucose Test Strip is only for<br>use with the Precision G Blood Glucose Testing System. |
| Intended Use: | The Precision QID Blood Glucose Testing System is intended for in<br>vitro diagnostic use (i.e., for external use only) for the quantitative<br>measurement of glucose in fresh capillary whole blood. For home or<br>professional use with the Precision QID Blood Glucose Sensor.<br>Compatible with the MediSense 2 Card and Pen Blood Glucose<br>Sensors, and the Companion 2 Card and Pen Blood Glucose Sensors.<br>The product may also be used by healthcare professionals for the<br>quantitative measurement of glucose in venous, arterial, or neonate<br>whole blood, provided the sample is used within 30 minutes of<br>collection.<br>The Precision G Blood Glucose Testing System is intended for in vitro<br>diagnostic use (i.e., for external use only) for the quantitative<br>measurement of glucose in fresh whole capillary blood. The Precision<br>G Blood Glucose Testing System is intended for home or professional<br>use. |
| Comparison to<br>Predicate Device: | The proposed Precision QID and Precision G Blood Glucose Test Strip<br>have technological characteristics equivalent to those of the predicate<br>Precision QID Blood Glucose Test Strip (K945887, K962295) and<br>predicate Precision G Blood Glucose Testing System (K963676). The<br>proposed Precision QID and Precision G Test Strip is comparable in<br>form, function, material composition, manufacturing process, and<br>intended use to the predicate Precision QID Test Strip and Precision G<br>Test Strip. In addition the intended use for the proposed Precision<br>QID and Precision G Test Strip is identical to the intended use of<br>another predicate device, the Accu-Chek Advantage Test Strip<br>(K951887, K954833). |
| Performance<br>Studies: | The performance of the Precision QID and Precision G Test Strip was<br>studied in the laboratory and in clinical settings by healthcare<br>professionals and lay users. The studies demonstrated that user can<br>obtain blood glucose results that are substantially equivalent to the<br>current methods for blood glucose measurement including the predicate<br>devices named above. |
| Conclusion: | Results of laboratory and clinical testing demonstrate that the<br>performance of the Precision QID and Precision G Blood Glucose Test<br>Strip when used according to the intended use stated above is<br>acceptable and comparable to the performance of the predicate devices<br>including the Precision QID Blood Glucose Test Strip (K945887,<br>K962295), the Precision G Blood Glucose Testing System (K963676),<br>and the Accu-Chek Advantage Test Strip (K951887, K954833). |

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design that resembles an abstract caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 8 1997

Mr. Michael G. Halpin · Manaqer Requlatory Affairs and Compliance -----Medisense, Inc. 4A Crosby Drive Bedford, MA 01730

Re : K971812/S001 Precision QID® and Precision G Blood Glucose Test Strip Requlatory Class: II Product Code: CGA Dated: July 31, 1997 Received: August 4, 1997

Dear Mr. Halpin:

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ್ಗ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

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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 qeneral 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/dsmamain.html".

Sincerely yours,
Steven Sitman

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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## Page I of I

## INDICATIONS FOR USE FORM

510(k) Number (if known): K945887; K962295

Device Name: Precision QID Blood Glucose Testing System

Indications For Use:

The Precision QID Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. For home or professional use with the Precision QID Blood Glucose Sensor. Compatible with the MediSense 2 Card and Pen Blood Glucose Sensors, and the Companion 2 Card and Pen Blood Glucose Sensors.

The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial, or neonate whole blood, provided the sample is used within 30 minutes of collection.

(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)

OL

Over-The-Counter Use

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number k97,812