GLUCOSE PILOT

K052208 · Tianjin New Bay Bioresearch Co., Ltd. · NBW · Dec 9, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052208
• Device Name: GLUCOSE PILOT
• Applicant: Tianjin New Bay Bioresearch Co., Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Glucose Pilot Blood Glucose Monitoring system is intended for in vitro diagnostic use. The system is intended to be used for the quantitative measurement of capillary blood glucose. The system is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

Glucose Pilot Blood Glucose Monitoring System measures glucose in capillary whole blood; utilizes disposable test strips with glucose oxidase reagent. User inserts strip; confirms code match between meter and strip bottle; applies fingerstick blood drop. Meter performs electrochemical measurement; displays result in 5 seconds; stores up to 350 results. Used by lay-users at home or professionals in clinical settings. Provides quantitative glucose concentration (mg/dL or mmol/L) to aid diabetes management. Includes meter, test strips, lancet device, and control solutions.

Clinical Evidence

No clinical data provided; substantial equivalence established through bench testing and comparison of technological characteristics and performance specifications against the predicate device.

Technological Characteristics

Electrochemical biosensor (electrode) technology. Measures glucose in capillary whole blood. Measurement range: 20-600 mg/dL. Sample volume: 1 microliter. Test time: 5 seconds. Power: 2 AAA batteries. Display: LCD. Connectivity: None. Memory: 350 tests. Operating range: 10-40°C, 25-90% humidity.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from a finger stick. Intended for lay-user home use and professional use. Not for neonates. For in vitro diagnostic use only.

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

• Ultra One Touch Glucose monitoring system (K024194)

Submission Summary (Full Text)

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### SECTION II 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

# 51O{k) Number: Designed K#: 052208

#### Submitter:

Tianjin New Bay Bioresearch Co., Ltd. #3 Jian She Rd, Ba Li Tai Industry Area Jin Nan District, Tianiin, China Telephone: [phone] Facsimile: 86-222-875-1516

#### Contact Person:

Rodrigo Berlie New Product Development Director Telephone: [phone] Facsimile: [phone]

#### Preparation Date:

Nov. 10. 2005 Device Information:

Device Classification Name: Quantitative of Blood glucose by using Electrochemical biosensor. Common/Usual Name: Blood Glucose Monitoring System. Proprietary Name: Glucose Pilot Glucose Monitoring System. Regulation Number: 21 CFR§862.1345, Glucose test system. 21 CFR§862.1660, Quantity Control Material Regulatory Name: Glucose Test System Product Code: NBW, CGA, JJX Regulatory Class: Class II

#### Predicate Devices:

Glucose Pilot Glucose Monitoring System is substantially equivalent to Ultra One Touch Glucose monitoring system of Life Scan. Cleared by FDA (K024194).

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#### Device Description:

The Glucose Pilot Glucose monitoring System consists of a hand-held blood glucose The Gracose Prior States, Lance device, storage case, and two levels of control meter, tost surps, innetter, Earins has a lot - specific calibration information and the meter reads automatically.

The meter is turned on by inserting the strip, the user supplies the capillary blood or The meter is turned on of morning meter makes an audible tone and starts the assay, which completes in five seconds. The meter's software converts the results read off the writen continers a plasma glucose concentration and displays the value on the meter's test surp into a plasma gavoss provided instructions and illustrations explaining that the blood drop will be pulled into the strip sample entry by capillary action. Results are stored in the meter's memory for tracking purposes.

#### Intended Use:

The Glucose Pilot Blood Glucose Monitoring system is intended for in vitro diagnostic use. The system is intended to be used for the quantitative measurement of capillary ase. The oysterials in intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control morram. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

#### Comparison to Predicate Device(s):

Glucose Pilot Glucose Monitoring System is substantially equivalent to cleared by FDA, e.g., Ultra One Touch Glucose Monitoring System (024194).

| CHARACTERISTICS | NEW DEVICE:<br><i>Glucose</i> Pilot BLOOD GLUCOSE<br>MONITORING SYSTEM | PREDICATE:<br>ONETOUCH™ ULTRA<br>GLUCOSE MONITORING<br>SYSTEM |
|------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Premarket Notification | K052208 | K024194 |
| Manufacturer | New Bay Bioresearch, Co. Ltd. | LifeScan, Inc (U.S.A.) |
| Type of Meter | Biosensor (Electrode) | Biosensor (Electrode) |
| Glucose Measurement Technology<br>(Test Strip) | <i>Glucose pilot</i> Test Strip | ONETOUCH™ Ultra Test Strip |
| Intended Use | To quantitatively measure glucose<br>in fresh capillary whole blood. | To quantitatively measure<br>glucose in fresh capillary whole<br>blood. |
| Sample Source | Capillary whole blood | Capillary whole blood |
| Sample Application | Blood sample is placed directly to<br>the test strip after finger is lanced. | Blood sample is placed directly<br>to the test strip after finger is<br>lanced. |

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| | | lanced. |
|-----------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Hematocrit Range | 30 - 55% | 30 - 55% |
| Control Solution(s) | Glucose pilot Control Solution | ONETOUCH™ Ultra Control Solution |
| Operating Temperature Range | 10°-40°C (50°-104°F) | 6°-44°C(43°-111°F) |
| Operating Humidity Range | 25-90% Relative Humidity | 10 – 90% Relative Humidity |
| Dimensions | 3.2" (L) x 2.3" (W) x 0.8"(H) | 3.12" x 2.25" x 0.85" |
| Weight | 2.5 ounces (72g) including 2 batteries | 1.5 ounces(43g) with battery |
| Display | Liquid Crystal Display (LCD) | Liquid Crystal Display (LCD) |
| Results Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | Stores 350 of the most recent blood test results. Results of the test solution are not stored in the memory. | 150 blood glucose and control solution tests |
| Test Start | Automatic | Automatic |
| Test Time | 5 seconds | 5 seconds |
| Power Source | Two replaceable AAA size batteries | One replaceable 3.0v lithium battery |
| Battery Life | Approximately 1000 glucose tests. | 1000 tests |
| Measurement Range | 20-600 mg/dL (1.1 to 33.3 mmol/L. Lower results are displayed as “LO”. Higher results are displayed as “HI”. | 20 - 600 mg/dL (1.1 to 33.3 mmol/L |
| Qualified Test Strip | Glucose pilot Test Strip | ONETOUCH™Ultra Test Strip |
| Sample Volume | Minimum of 1 micro liter | Minimum of 1 micro liter |

## Summary:

The information provided in this pre-market notification demonstrates that Clucose Plot I he information provided in and per mixalent to Ultra One Touch Blood Glucose Monitoring Montoning System is succembary of equipment ated through comparison of intended use and System Substantial Cquiration was lable and analytical predicate devices. The pliysical proportios to the commerceded notification provides reasonable assurance that the Information supplied in this pro marketing safe and effective for its stated intended use.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

2005

DEC 9

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Tianjin New Bay Bioresearch Co., Ltd. c/o Mr. Rodrigo Berlie New Product Development Director Aviara Biotech, LLC 3108 Avenida Olmeda Carlsbad, CA 92009

k052208 Re:

R052200
Trade/Device Name: Glucose Pilot Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX, Dated: October 27, 2005 Received: November 9, 2005

Dear Mr. Berlie,

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your booton stock process is substantially equivalent (for the indications for relered above and nave decemined the esse predicate devices marketed in interstate commerce use stated in the encreative to regary manolitics of the Medical Device Amendments, or to devices that provision with 20, 1770, the onactions associations of the Federal Food, Drug, and Cosmetic have bech recalssinod in accordance wif a premarket approval application (PMA). You may, Act (Act) that ao not require apple to the general controls provisions of the Act. The general therefore, mailion the do roo, one joide requirements for annual registration, listing of devices, good Controls provisions or also and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may of subject to sublications: consistent (CFR), Parts 800 to 895. In addition, FDA may round in further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that 1 Dr. 3 team. to t your device complies with other requirements of the Act or that FDA nas made a decemination administered by other Federal agencies. You must comply with ally rederal statutes and regarante abut not limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements, melaining 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) I his letter will anow you to begin marketing your over of your device to a legally premarket notification. "The PDT Intently of 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, If you desire specific information advertising of your device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the Vitto Daglosito Dorios Lranian by reference to premarket notification" (21CFR Part 807.97). I guilanon chitica, "Misolunding of responsibilities under the Act from the I ou may other 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 G

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 STATEMENT

0 510(k) Number: K05228

Glucose Pilot Blood Glucose Monitoring System Device name:

### Indications for Use:

The Glucose Pilot Blood Glucose monitoring System is intended for the quantitative The Classes in fresh capillary whole blood from a finger stick, for the lay-user. It is also intended for the professional use, which include fresh capillary ia) assn and It is intended for use outside the body (in vitro diagnostic use) by whole blood. It is in the control.

Prescription Use __ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ AND/OR (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)

Carol C. Benson

Division Sign-Off

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. Office of In Vitro Diagnostic Device Evaluation and Safety 510(k): K052208