PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST

K982303 · Medisense, Inc. · CGA · Dec 8, 1998 · Clinical Chemistry

Device Facts

• Record ID: K982303
• Device Name: PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST
• Applicant: Medisense, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Dec 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Precision·G Plus Point of Care Management System is intended for the in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Precision·G Plus Point of Care Management System is for home (lay user) or professional use. The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial or neonatal whole blood, provided the sample is used within 30 minutes.

Device Story

System uses amperometric biosensor technology to measure blood glucose; input is fresh capillary, venous, arterial, or neonatal whole blood sample; device generates electrical current proportional to glucose concentration; provides quantitative glucose measurement; used in home or clinical settings by lay users or healthcare professionals; output displayed to user for clinical decision-making; aids in glucose monitoring and management.

Clinical Evidence

Performance evaluated in laboratory and clinical settings by healthcare professionals and lay users. Studies demonstrated that users obtain blood glucose results substantially equivalent to predicate devices.

Technological Characteristics

Amperometric biosensor technology; quantitative measurement of glucose via current generation; supports capillary, venous, arterial, and neonatal whole blood samples.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood for home or professional use; also indicated for venous, arterial, or neonatal whole blood use by healthcare professionals (sample 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·G® Blood Glucose Testing System (K963676)
• Precision QID® Blood Glucose Testing System (K944195)
• Precision QID® and Precision·G® Blood Glucose Test Strip (K945887, K962295, K971812)
• Johnson and Johnson Surestep Pro System (K970556)

Submission Summary (Full Text)

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K987303

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## Summary of Safety and Effectiveness

| Submitted by: | Michael Halpin<br>Manager, Regulatory Affairs and Quality Systems<br>MediSense, Incorporated<br>4A Crosby Drive<br>Bedford, Massachusetts 01730 |
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| Device Name: | Precision·G Plus Point of Care Management System<br>for Blood Glucose Testing |
| Common Name: | Blood Glucose Testing System |
| Classification: | Glucose Test System<br>Class II per 21 CFR 862.1345 |
| Predicate Devices: | Precision·G® Blood Glucose Testing System--K963676<br>Precision QID® Blood Glucose Testing System--K944195<br>Precision QID® and Precision·G® Blood Glucose Test Strip--<br>K945887, K962295, K971812<br>Johnson and Johnson Surestep Pro System -- K970556 |
| Description: | The Precision·G Plus Point of Care Management System for Blood<br>Glucose Testing utilizes amperometric biosensor technology to<br>generate a current. The size of the current is proportional to the<br>amount of glucose present in the sample providing a quantitative<br>measure of glucose in whole blood and control solutions. |
| Intended Use: | The Precision·G Plus Point of Care Management System is intended<br>for the in vitro diagnostic use (i.e. for external use only) for the<br>quantitative measurement of glucose in fresh capillary whole blood.<br>The Precision·G Plus Point of Care Management System is for<br>home (lay user) or professional use. |
| | The product may also be used by healthcare professionals for the<br>quantitative measurement of glucose in venous, arterial or neonatal<br>whole blood, provided the sample is used within 30 minutes. |
| Comparison to<br>Predicate Device: | The proposed Precision·G Plus Point of Care Management System<br>has equivalent technological characteristics and the same intended<br>use as both the Precision·G® Blood Glucose Testing System<br>(K963676, K971812) and the Precision QID® Blood Glucose<br>Testing System (K944195, K971812). In addition, the Precision·G<br>Plus Point of Care Management system is substantially equivalent |
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| | to an additional competitive predicate device, the Johnson and<br>Johnson Surestep Pro Blood Glucose Monitoring System<br>(K970556). |
| Performance<br>Studies: | The performance of the Precision G Point of Care Management<br>System was studied in the laboratory and in clinical settings by<br>healthcare professionals and lay users. The studies demonstrated<br>that user can obtain blood glucose results that are substantially<br>equivalent to the current methods for blood glucose measurement<br>including the predicate devices named above. |
| Conclusion: | Results of laboratory and clinical testing demonstrate that the<br>performance of the Precision G Point of Care Management system<br>when used according to the intended use stated above is acceptable<br>and comparable to the performance of the predicate devices<br>mentioned above. |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Michael Halpin DEC 8 1998 Manager, Requlatory Affairs and Quality Systems MediSense, Incorporated 4A Crosby Drive Bedford, Massachusetts 01730

K982303 Re: Precision-G Plus Point of Care Management System for Trade Name: Blood Glucose Testing Requlatory Class: II Product Code: CGA Dated: June 30, 1998 Received: July 1, 1998

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 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 requlations 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 regulations.

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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 G Plus Point of Care Management System for Blood Glucose

Indications For Use:

The Precision G Plus Point of Care Management System for Blood Glucose is intended for the in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Precision. G Plus Point of Care Management System is for home (lay user) or professional use.

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

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Concurrent of CDRH, Office of Device Evaluation (ODE) L Over-The-Counter Use Prescription Use Or (Per 21 CFR 801.108) (Division Sign-Off) Division of Clinical Labo

510(k) Number .