PRODIGY

K053593 · Diagnostic Devices, Inc. · NBW · Jul 6, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053593
• Device Name: PRODIGY
• Applicant: Diagnostic Devices, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Prodiqy Blood Glucose Test System is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. It is intended for use by people with diabetes mellitus at home (Over -the-Counter) as an aid in monitoring the effectiveness of diabetes control program. The Prodigy blood glucose test system can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood. 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

Prodigy Blood Glucose Test System comprises a meter and dry reagent biosensor test strips. System measures glucose in fresh capillary whole blood or control solutions via electrochemical method. Current magnitude is proportional to glucose concentration; provides quantitative output. Used at home by patients or in clinical settings by healthcare professionals. Meter requires code strip calibration. Output assists in monitoring diabetes control programs. Device is portable; provides quantitative glucose readings to aid clinical decision-making regarding diabetes management.

Clinical Evidence

Clinical performance evaluated via consumer study with 120 lay users (ages 17-66) and professional comparison. Accuracy assessed against YSI reference method. Results: 98% of samples <75 mg/dL fell within ±15 mg/dL; 98% of samples ≥75 mg/dL fell within ±20%. Method comparison (n=120) yielded y=1.03x - 2.98, R²=0.98. Lay user performance showed high correlation (r=0.976-0.978) with professional results.

Technological Characteristics

Electrochemical biosensor using glucose oxidase enzyme. Amperometric detection method. Features automatic temperature compensation via built-in thermistor. Dimensions: 88x62x22 mm. Weight: 26.5g. Calibration via code strip. Standards: CLSI EP5-A, EP6-P2, EP7-P; EN 60601-1, EN 61010-1, EN 61010-2-101.

Indications for Use

Indicated for quantitative glucose measurement in capillary whole blood from fingertips. Intended for home use by individuals with diabetes mellitus to monitor diabetes control programs and for professional use in clinical settings. 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

• TaiDoc Technology Corporation, Achtung TD-4207/ Clever Chek TD-4209/ Clever Chek TD-4222 Glucose Test Systems (K042005)

Submission Summary (Full Text)

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# 510 (k) Summary

#### General Information Establishment

JUL - 6 2006

Applicant: DIAGNOSTIC DEVICES, INC.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: December 21, 2005

#### 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 Matcrial) 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.

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## Indications for Use:

The Prodigy Blood Glucose Test System is intended for use in the quantitative measurement of glucose in whole blood taken from the finger. 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.

# 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 |
| Test strip calibration | Code strip | Code strip |
| Sample volume | 1.8-2.5 uL | 1.8-2.5 uL |
| Test time | 10 sec. | 10 sec. |
| Operating condition | 10 - 40°C | 10 - 40°C |
| and humidity range | 10 - 90 % R.H. | 10 - 90 % R.H. |
| Storage/Transportation<br>condition | -20 - 70°C<br>5 - 95 % R.H. | -20 - 70°C<br>5 - 95 % R.H. |
| Difference | | |
| Item | New Device: Prodigy | Predicate K042005 |
| Size | 88mm X 62mm X 22mm | 80mm X 60mm X 20mm |
| Weight | 26.5 g | 48.79 g |

# Substantial Equivalence Chart:

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# Conclusion

After analyzing clinical and non-clinical testing data, it is the conclusion of Diagnostic Devices, 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 its wings spread, and three horizontal bars below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k053593

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 12, 2006 Received: June 14, 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 udictions 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 provisiops of the I ( The general controls provisions of the Act include requirements for annual registration, inte rece devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

JUL - 6 2006

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your revire, 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 Degister.

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 Isiting (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing pratice requirements as set forth in the quality systems (QS) regulation (2) 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, pervoits 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 tloin the [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Alberto Gutierrez, Ph.D.

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: K053593

Device Name: Prodigy Blood Glucose Test System

Indications For Use:

The Prodiqy Blood Glucose Test System is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. It is intended for use by people with diabetes mellitus at home (Over -the-Counter) as an aid in monitoring the effectiveness of diabetes control program. The Prodigy blood glucose test system can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood. 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.

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

Over-The-Counter Use (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)

Carole Benson
Revision Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

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