Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM

K050182 · Biomedix, Inc. · CGA · Aug 9, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050182
• Device Name: Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEM
• Applicant: Biomedix, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Aug 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Q. STEPS Biometer G/C Dual Monitoring System is intended for use with Q.STEPS Glucose and Cholesterol Test Strips with Q. STEPS Biometer G/C by healthcare professionals and home users. Q. STEPS Biometer G/C System provides a quantitative measurement of Glucose and Cholesterol in whole blood from the fingertips. The Glucose measurements are used in helping the management of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatitis islet cell tumors. Cholesterol measurements are used in the management of disorders involving excess cholesterol in the blood, lipid and lipoprotein metabolism disorders.

Device Story

System uses enzymatic electrochemical biosensor technology to measure whole blood glucose and cholesterol. Finger-stick blood applied to disposable test strips; Glucose Oxidase or Cholesterol Oxidase catalyzes reduction-oxidation reaction; electron transfer at silver electrode surface generates current proportional to analyte concentration. Meter quantifies current and displays results. Used by healthcare professionals and home users. Includes lot-specific EEPROM calibration chip inserted by user for cholesterol testing. Provides quantitative data for clinical management of metabolic disorders.

Clinical Evidence

Clinical method comparison studies conducted at three sites with 456 patients. Glucose performance compared against YSI reference; Cholesterol performance compared against CRMLN reference. Precision studies (within-run CV 1.0-8.0%) and linearity studies (R² 0.96-0.99) performed. Bias at medical decision points (200/240 mg/dL) for cholesterol was ~4.65% positive and 2.33% negative. Results support substantial equivalence.

Technological Characteristics

Enzymatic electrochemical biosensor; Glucose Oxidase/Cholesterol Oxidase; silver electrode surface. Amperometric measurement. Dimensions: disposable test strips with half-circle (glucose) or circular (cholesterol) test spots. Connectivity: lot-specific EEPROM calibration chip. Storage: 2-30°C. Provides plasma-equivalent results.

Indications for Use

Indicated for quantitative measurement of glucose and cholesterol in whole blood from fingertips in adults and children. Used for management of carbohydrate metabolism disorders (diabetes mellitus, idiopathic hypoglycemia, pancreatic islet cell tumors) and lipid/lipoprotein metabolism disorders.

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

• Q STEPS™ Biometer G Blood Glucose Monitoring System (K033627)
• Polymer Technology Systems, Inc., PTS PANELS Lipid Panel Test Strips (K023558)
• One Touch Basic/Profile/One Touch II Test Strips, LifeScan, Inc.(K031472)

Submission Summary (Full Text)

{0}------------------------------------------------

K050182

## 510(K) Summary

This summary of safety and effectiveness information is submitted in compliance with 21CFR 807.92.

- 1. Application Date: November 30, 2004
AUG 0 9 2005

### 2. Applicant Information:

Biomedix Inc., USA 40471 Encyclopedia Circle, Fremont, CA 94538 Establishment Registration No.: 3004525092

Contact Person:Paul K Shieh, Ph.D Judy S. Chen, Ph.D. Phone Number: 510-438-9500 ext 401, 405 510-366-8270 (Cell) 510-449-1554 (Cell) 510-438-9141 Fax Number: ShiehPaul @Yahoo.com e-mail: [e-mail]

### 3. Trade Names:

Q.STEPS™ Biometer G/C Dual Monitoring System

#### Device Description: ধ:

The Q. STEPS™ Biometer G/C Dual Monitoring System uses enzymatic electrochemical The Q. OTEL O - Blomotor OF Blan easy measurement of the whole blood glucose and blosensor technology for a quier and is applied to the test spot of the biosensor (test cholesterol levels. When inger sist occurs. The oxidation of D-Glucose or Cholesterol sthp), a reduction oxidation room of Cholesterol Oxidase respectively, causes which is cataly.cod by Oldooo extraces; and therefore, the magnitude of the an electron transfer at the glucose or cholesterol concentration in the blood. current produced is propertional to the guantify the glucose and the cholesterol levels in the blood , and then display on the readout of the monitor.

### 5. Classification Name:

Cholesterol test system Glucose test system Product Codes: CHH, CGA

#### Device Classification: 6.

- Q.STEPS™ Biometer G/C and Glucose Test Strips Class II devices (21 C.F.R. 1. 5862.1345, Glucose Test System)
- Q.STEPS™ Biometer G/C and Cholesterol Test Strips Class I devices (21 C.F.R. 2. §862.1175, Cholesterol Test System)

{1}------------------------------------------------

### 7. Intended Use

The Q STEPS Biometer G/C Dual Monitoring System is intended for use with Q STEPS Glucose and Cholestero! Test Strips with Q.STEPS Biometer G/C by healthcare professionals and home users. Q.STEPS Biometer G/C, System provides a quantitative measurement of Glucose and Cholesterol in whole blood from the fingertips. The Glucose measurements are used in helping the management of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors. Cholesterol measurements are used in the management of disorders involving excess cholesterol in the blood, lipid and lipoprotein metabolism disorders.

### 8. Reason for 510K

New Device application of 510K Clearance

### 9. Predicate Devices

The predicate devices for determination of Substantial Equivalence are:

- 1. Q STEPS™ Biometer G Blood Glucose Monitoring System (K033627)
- 2. Polymer Technology Systems, Inc., PTS PANELS Lipid Panel Test Strips (K023558))
- One Touch Basic/Profile/One Touch II Test Strips, LifeScan, Inc.(K031472) ని.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

AUG 9 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Judy S. Chen, Ph.D. Consultant Biomedix, Inc. 40471 Encyclopedia Circle Fremont CA, 94538

-

k050182 Re:

R050102
Trade/Device Name: Q.STEPS Biometer G/C Dual Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, CHH, JJX Dated: May 12, 2005 Received: May 16, 2005

Dear Dr. Chen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your cover your colermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conimered pror co rial) 2011-12-11 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). and Cosmetic receive, market the device, subject to the general controls provisions of the Act. The I va may, morelore, manso 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 your device to such additional controls. Existing major regulations affecting your device it may be subject to back adon and 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 I loase be actived a determination that your device complies with other requirements of the Act than I Drederal statutes and regulations administered by other Federal agencies. You must or any I vith 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).

{3}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the support of any for the first of section of your device to lle i his letter will anow you to ocgin nativeling your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, premarket notification. The FDA induitg of substantal of the most of the may be device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, af In If you desire specific information acount in appear the spease contact the Office of In
or questions on the promotion and advertising of your and and and and also, mass note of questions of the promotion and advertising of your . Also, please note the Vito Diagnostic Device Livanation and Barco ... (----------------------------------------------------------------------------------------------------------------------------fegulation entitled, "Misoranant of Telection on your responsibilities under the Act from the You may obtain other general information on your respected at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benam

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# ATTACHMENT 4 Indications for Use

510(k) Number:

Device Name:

K 050182

Q. STEPS Biometer G/C Dual Monitoring System

Indications: For Use:The Q.STEPS Biometer G/C Dual Monitoring System is intended
Indications: For States of Chalasterel Tost Strips with O STEPS Biometer Indications: For Use: The Q.STEPS Blonneter O/O Dualtining eyes Biometer
for use with Q.STEPS Glucose and Cholesterol Test Strips with Q.STEPS Biometer G/C System for use with Q.STEPS Glucose and Unblesterer rest Stipb min and Children G/C System.
G/C by healthcare professionals and home users. Q.STEPS Biometer G/C System. G/C by healthcare professionals and home users. provides a quantitative measurement of charity of the management of
the fingertips. The Glucose measurements are used in helping the management the fingertips. The Glucose measurements are used in new on one of one of the finger in the carbohydrate metabolism disolutions massurements are used in the and pancreatic islet cell tumors. Cholesterol measurements are associations and lipoprotein
management of disorders involving excess cholesterol in the blood, lipid and lipo metabolism disorders.

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

Over-The-Counter (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)

Alberto Su
Division Sign-Off

Page 1 of of _________________________________________________________________________________________________________________________________________________________________

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K050182