BETACHEK GLUCOSE TEST

K062187 · National Diagnostic Products · NBW · Mar 24, 2009 · Clinical Chemistry

Device Facts

• Record ID: K062187
• Device Name: BETACHEK GLUCOSE TEST
• Applicant: National Diagnostic Products
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

Betachek Blood Glucose is a test intended to be used by non-diabetic individuals to estimate their fasting blood glucose (blood sugar) level from a drop of blood obtained from a finger stick. Any abnormal results should be verified by a medical professional, such as a physician, and confirmed with a quantitative, laboratory reference method. Only a trained medical professional can determine if an individual has diabetes. Test results within the normal range do not necessarily mean that the individual does not have diabetes or pre-diabetes. Any individuals who are concerned that they may have diabetes or pre-diabetes should seek the advice of a physician. Betachek Blood Glucose is not intended to be used for children or by individuals who are diabetic or pregnant. This test can not be used to screen or diagnose diabetes. It should not be used for children or by individuals who are diabetic or pregnant. This test is only intended for individual use at home. It is not for use as part of a screening program in a healthcare setting or any other setting.

Device Story

Visually read test strip for semi-quantitative glucose measurement; uses capillary whole blood from finger stick. Reagent zones (glucose oxidase, peroxidase, tetramethylbenzidine) react with glucose to produce color change; intensity proportional to glucose concentration. User compares strip color to 5-increment chart (50, 75, 100, 125, 150 mg/dL) on canister label. Intended for home use by non-diabetic individuals; self-operated. Output provides estimated fasting glucose level; abnormal results require professional medical verification. Benefits include accessible, rapid estimation of fasting glucose for individuals concerned about diabetes/pre-diabetes.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and bench testing comparing the device to the predicate, including enzyme-linked colorimetric performance, test range, and operating temperature.

Technological Characteristics

Visual, non-instrumented test strip. Reagents: Glucose Oxidase (Aspergillus niger), Peroxidase, and dyes (TMB, APAC, DCP). Test range: 50-150 mg/dL. Test time: 3 minutes. Hematocrit range: 35%-55%. Operating temperature: 18-35°C. No electronic components or connectivity.

Indications for Use

Indicated for non-diabetic individuals to estimate fasting blood glucose levels via finger stick capillary blood. Contraindicated for children, pregnant individuals, and those already diagnosed with diabetes. Not for screening or diagnostic use.

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

• Chemcard Glucose Test (K943503)

Submission Summary (Full Text)

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According to the requirements of 21 CFR 807.92, the following information a) provides sufficient detail to understand the basis for a determination of substantial equivalence.

- 1. Submitter's Name:
National Diagnostic Products (Aust) Pty Ltd

Address:

| Phone: | |
|-----------------|--|
| Fax: | |
| Contact Person: | |
| Date Prepared: | |

22/39 Herbert Street. St.Leonards NSW 2065, Australia [phone] [phone] Brandon Bransgrove March 24, 2009

- 2. Device Name: Proprietary/Trade name: Common Name: Classification Name: Device Classification: Requlation Number: Classification Panel: Product Code:
- 3. Predicate Device Name: Manufacturer: 510 (K) Number:

Glucose Test System 21 CFR 862.1345 Clinical Chemistry (75) CGA (Glucose Oxidase, Glucose)

Betachek Blood Glucose Test

Betachek Blood Glucose Test

Glucose Test System

Chemcard Glucose Test CHEM-ELEC, INC K943503

4. Description of the Device Reagent test principle - glucose oxidase

## 5. Intended Use

Betachek Blood Glucose Test is a test intended to be used by non-diabetic individuals at home to estimate their fasting blood glucose (blood sugar) level from a drop of blood obtained from a finger stick.

Any abnormal results should be verified by a medical professional, such as a physician, and confirmed with a quantitative, laboratory reference method. Only a trained medical professional can determine if an individual has diabetes. A test result within the normal range does not exclude the possibility that the individual has diabetes or pre-diabetes. Any individual who is concerned that he or she may have diabetes or pre-diabetes should seek the advice of a physician.

Betachek Blood Glucose Test is not intended to be used for children or by individuals who are diabetic or pregnant.

This test can not be used to screen or diagnose diabetes. It should not be used for children or bv individuals who are diabetic or preqnant. This test is only intended for individual use at home.

It is not for use as part of a screening program in a healthcare setting or any other setting.

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| Similarities | | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Device | Predicate |
| | Betachek Blood<br>Glucose Test | Chemcard Glucose Test |
| Detection Method | Enzyme linked colour<br>change | Enzyme linked colour<br>change |
| Sample | Finger stick blood sample | Finger stick blood sample |
| Sample Volume | 1 drop (no sample<br>premeasurement) | 1 drop (no sample<br>premeasurement) |
| Enzyme 1 | Glucose Oxidase<br>(Aspergillus niger) | Glucose Oxidase<br>(Aspergillus niger) |
| Enzyme 2 | Peroxidase | Peroxidase |
| Dye | TMB, APAC, DCP | TMB |
| Instrument required | No | No |
| Intended use | a test intended to be used<br>by non-diabetic individuals<br>at home to estimate their<br>fasting blood glucose<br>(blood sugar) level from a<br>drop of blood obtained<br>from a finger stick. | a semi-quantitative glucose<br>test intended to be used by<br>a person who has not been<br>diagnosed as diabetic to<br>measure his or her fasting<br>glucose level in order to<br>determine whether the<br>fasting glucose level is<br>abnormal |
| Operating Temperature | 18 - 35° C | 18 – 35° C |
| Test Range | 50 mg/dL - 150 mg/dL | 50 mg/dL - 150 mg/dL |
| Test Time | 3 minute | 3 minutes |
| Number of colour blocks | 5 | 5 |

| Differences | | |
|------------------|---------------------------------------------------------------|------------------------------------------------------------------------|
| Item | Device | Predicate |
| | Betachek Blood<br>Glucose Test | Chemcard Glucose Test |
| Format | Test strip | Test Card |
| User steps | Blood wiped at 1 minute<br>and result read after<br>3minutes. | Card Peeled at 3 minutes<br>and result must read within<br>30 seconds. |
| Hematocrit Range | 35% - 55% | Unknown |

## 7. Performance Characteristics

Betachek Blood Glucose Test has the same intended use and technological characteristics as the predicate device and clinical evaluations demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Therefore, Betachek Blood Glucose Test is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

National Diagnostic Products c/o Mr. Brandon Bransgrove 7-9 Merriwa Street, Gordon Sydney, NSW, 2072 Australia

MAR 2 4 2009

Re: k062187

> Trade Name: Betachek Blood Glucose (Sugar) test Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA Dated: December 22, 2008 Received: December 24, 2008

Dear Mr. Bransgrove:

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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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/dsma/dsmamain.html.

Sincerely yours.

Cary C. He

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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## Indication for Use

K062187 · · · 510(k) Number:

BETACHEK BLOOD GLUCOSE (SUGAR) TEST Device Name:

Indication For Use:

Betachek Blood Glucose (Sugar) is a test intended to be used by non-diabetic individuals at home to estimate their fasting blood glucose (blood sugar) level from a drop of blood obtained from a finger stick.

Any abnormal results should be verified by a medical professional, such as a physician, and confirmed with a quantitative, laboratory reference method. Only a trained medical professional can determine if an individual has diabetes. A test result within the normal range does not exclude the possibility that the individual has diabetes or pre-diabetes. Any individual who is concerned that he or she may have diabetes or pre-diabetes should seek the advice of a physician.

Betachek Blood Glucose Test is not intended to be used for children or by individuals who are diabetic or pregnant.

This test can not be used to screen or diagnose diabetes.

It should not be used for children or by individuals who are diabetic or pregnant.

This test is only intended for individual use at home.

It is not for use as part of a screening program in a healthcare setting or any other setting.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D) And/Or

V Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

signature

Division Sign-Off Øffice of In Vitro Diagnostic Device Evaluation and Safety

510(k) K062187