PRODIGY BLOOD GLUCOSE TEST SYSTEM

K060467 · Diagnostic Devices, Inc. · NBW · Jul 13, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060467
• Device Name: PRODIGY BLOOD GLUCOSE TEST SYSTEM
• Applicant: Diagnostic Devices, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Prodigy Blood Glucose Test System is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and not intended for use on neonates. The Prodigy meter is to be used with the Prodigy Blood Glucose Test Strip, and the Prodigy Glucose Control Solutions.

Device Story

System consists of electrochemical meter and dry reagent biosensor test strips; measures glucose in capillary whole blood from fingertip or palm. Principle of operation: electrochemical method where current is proportional to glucose concentration in sample. Used by healthcare professionals and patients at home for diabetes management. Features voice broadcast function. Provides quantitative glucose measurement to aid in monitoring diabetes control programs. Does not diagnose or screen for diabetes.

Clinical Evidence

Clinical evaluation included a method comparison study with 120 patients (3 sites) comparing Prodigy meter to Roche Accu-chek (r=0.9852-0.9897). A consumer study with 60 lay users validated palm vs. fingertip testing (r=0.9847). Accuracy was verified against YSI-2300 reference method (r=0.969 for lay users). Precision studies (within-day and day-to-day) showed CVs ranging from 1.62% to 4.85% across 5 glucose concentrations. Interference testing confirmed no significant impact from common exogenous/endogenous substances at physiological levels.

Technological Characteristics

Electrochemical meter with dry reagent biosensor test strips. Uses glucose oxidase enzyme. Test range: 20-600 mg/dL. Sample volume: 0.7 uL. Test time: 7 seconds. Operating conditions: 10-40°C, <85% R.H. Dimensions: 96mm x 23mm x 45mm. Weight: 76.15g. Includes voice broadcast function.

Indications for Use

Indicated for quantitative glucose measurement in capillary whole blood (fingertip/palm) for healthcare professionals and patients with diabetes mellitus to monitor diabetes control programs. Contraindicated for neonates and not for diabetes diagnosis or screening.

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

• Achtung TD-4207/ Clever Chek TD-4209/ Clever Chek TD-4222 Glucose test Systems (k042005)

Submission Summary (Full Text)

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K060467

# 510 (k) Summary, Prodigy Blood Glucose System

JUL 1 3 2006

## General Information Establishment

Applicant: DIAGNOSTIC DEVICES, INC.. Address: 8935 NW 27th street, Miami, FL 33172. U.S.A. Registration Number: 3004622211 Contact Person: Rick Admani Abulhaj Director of Finance and Operation TEL: [phone] FAX: [phone] Data submitted: February 21, 2006

## Device

Proprietary /Trade Name: Prodigy Blood Glucose Test System Common Name: Blood Glucose Test System Classification Name: SYSTEM, TEST BLOOD GLUCOSE, Class II Regulation sections: 21 CFR § 862.13485, Glucose Test System 21 CFR § 862.1660, Quality Control Material, assayed and Unassayed. Classification: Class II (Glucose Test System) Class I -reserved (Quality Control Material) Product code: NBW, CGA (Glucose Test System) JJX (Quality Control Material) Panel: 75 (Clinical Chemistry)-Glucose Test system and Quality Control Material

## Safety and Effective Information

## Predicate Device:

Claim of Substantial Equivalence (SE) is made to TaiDoc Technology Corporation. K042005, Achtung TD-4207/ Clever Chek TD-4209/ Clever Chek TD-4222 Glucose Test Systems.

## Indications for Use:

The Prodigy Blood Glucose Test System is intended for use in the quantitative

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# 510 (k) Summary, Prodigy Blood Glucose System

measurement of glucose in capillary whole blood from the fingertip and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

#### Device Description:

The Prodigy glucose test system consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions. The system also provides voice broadcast function when the meter is used to test.

## Safety and Effectiveness, comparison to predicate device:

The results of clinical and non-clinical testing indicate that the new device is as safe and effective as the predicate.

| Similarities | | |
|------------------------|---------------------|--------------------|
| Item | New Device: Prodigy | Predicate K042005 |
| Enzyme | Glucose oxidase | Glucose oxidase |
| Test range | 20-600 mg/dL | 20-600 mg/dL |
| Sample volume | 0.7 uL | 1.8-2.5 uL |
| Test time | 7 sec. | 10 sec. |
| Operating condition | 10 - 40°C | 10 - 40°C |
| and humidity range | Below 85 % R.H. | 10 - 90 % R.H. |
| Storage/Transportation | -20 - 70°C | -20 - 70°C |
| condition | Below 85 % R.H. | 5 – 95 % R.H. |
| Difference | | |
| Item | New Device: Prodigy | Predicate K042005 |
| Size | 96mm X 23mm X 45mm | 80mm X 60mm X 20mm |
| Weight | 76.15 g | 48.79 g |

#### Substantial Equivalence Chart:

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# 510 (k) Summary, Prodigy Blood Glucose System

## Conclusion

:

After analyzing clinical and non-clinical testing data, it is the conclusion of Diagnostic Devices, Inc., Inc., Inc. that the Prodigy Blood Glucose Test system is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalence to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Diagnostic Devices, Inc. c/o Mr. Daniel Kamm Regulatory Engineer Kamm & Associates PO Box 7007 Deerfield, IL 60015

JUL 1 3 2006

k060467 Re:

Trade/Device Name: Prodigy Blood Glucose Test System Regulation Number: 21 CFR\$862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: June 30, 2006 Received: July 3, 2006

Dear Mr. Kamm:

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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#### Page 2 -

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/industry/support/index.html.

Sincerely yours,

Alberto Guti

Alberto Gutierrez, Ph.D. 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:

Device Name: Prodigy Blood Glucose Test System

Indications For Use:

The Prodigy Blood Glucose Test System is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and not intended for use on neonates.

The Prodigy meter is to be used with the Prodigy Blood Glucose Test Strip, and the Prodigy Glucose Control Solutions.

Image /page/5/Picture/6 description: The image shows two options: "Prescription Use" and "Over-The-Counter Use". The "Prescription Use" option, labeled with "(Part 21 CFR 801 Subpart D)", has been marked with an "X". The "Over-The-Counter Use" option, labeled with "(21 CFR 807 Subpart C)", has also been marked with an "X". There is also an "AND/OR" option in between the two options.

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

Carl Benson
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Division Sign-Off

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