BIOSCANNER PLUS; LIPID PANEL TEST STRIPS

K013173 · Polymer Technology Systems, Inc. · CHH · Oct 22, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013173
• Device Name: BIOSCANNER PLUS; LIPID PANEL TEST STRIPS
• Applicant: Polymer Technology Systems, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Oct 22, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Intended Use

The Lipid Panel Test Strips are intended to measure cholesterol, HDL cholesterol and triglycerides in whole blood on a BioScanner Plus analyzer. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. The BioScanner Plus is intended to be used by healthcare professionals to measure blood analytes on a test strip.

Device Story

BioScanner Plus is a reflectance photometer for in vitro diagnostic use. Input: whole blood applied to Lipid Panel Test Strips. Test strips consist of plastic holders with chemically treated membranes that separate red blood cells and react with serum/plasma to produce color. Device measures color intensity via four optical read windows; converts intensity to analyte concentration. System uses lot-specific EEPROM chips containing calibration curves; chip inserted by user with new test strip lots. Failsafe feature verifies match between EEPROM and strip lot. Used by healthcare professionals to provide quantitative lipid results; aids clinical decision-making for metabolic and cardiovascular disorders.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and design comparison to predicate devices.

Technological Characteristics

Reflectance photometer; four optical read windows. Dry phase test strips with chemically treated membranes. Lot-specific EEPROM chip for calibration curve storage. Standalone device.

Indications for Use

Indicated for healthcare professionals to measure cholesterol, HDL cholesterol, and triglycerides in whole blood for the diagnosis and treatment of lipid/lipoprotein metabolism disorders, diabetes mellitus, atherosclerosis, liver disease, renal disease, nephrosis, and endocrine disorders.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Predicate Devices

• BioScanner (K972669)
• BioScanner Cholesterol Test Strips (K981493)
• HDL Cholesterol Test Strips (K990247)
• Triglycerides Test Strips (K991894)

Submission Summary (Full Text)

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

K 013/73

### 510(k) SUMMARY

This summary of safety and effectiveness information is submitted in compliance with 21CFR807.92.

- 1. Application Date:
September 11, 2001

#### 2. Applicant Information:

Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268 Contact Person: Margo Enright Phone Number: 317-870-5610 FAX Number: 317-870-5608 e-mail: [e-mail]

- 3. Trade Names:
BioScanner Plus Lipid Panel Test Strips

- 4. Description:
The BioScanner Plus is a reflectance photometer for in vitro diagnostic use with Polymer Technology System's (PTS) test strips to measure color developed in a chemical reaction that occurs when whole blood is placed on a test strip. The color is measured and converted into concentration for each analyte.

The Lipid Panel Test Strips are dry phase test strips that are constructed from a plastic strip holder that holds chemically treated membranes. When whole blood is placed on the test strip, the membranes first separate and isolate the red blood cells, allowing the serum/plasma to flow to the reaction membranc and react to produce a color change. The Lipid Panel Test Strips are for in vitro diagnostic use with the BioScanner Plus reflectance photometer.

The only modification that was made to the BioScanner to produce the BioScanner Plus was: A fourth optical read window was added to the three optical read windows in the BioScanner.

The only modification that was made to the Cholesterol, HDL Cholesterol and Triglycerides test strips to produce the Lipid Panel Test Strips is that the reaction membranes from the three individual test strips were assembled together on one test strip holder that holds all three at once.

#### રું. Classification Names:

Cholesterol test system Lipoprotein test system Panel: Clinical Chemistry 75

Panel: Clinical Chemistry 15

- 6. Facility Address:
7736 Zionsville Road Indianapolis, IN 46268

#### 7. Device Classification:

Class I (Regulation: 21 CFR 862.1475. 862.1175. 862.1705)

![]()

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

### 8. Intended Use:

The Lipid Panel Test Strips are intended to measure cholesterol, HDL cholesterol and triglycerides in whole blood on a BioScanner Plus analyzer. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

#### 9. Reason for 510(k):

Device Modification

#### Predicate Device Information 10.

The following are the predicate devices for determination of substantial equivalence:

Name: BioScanner, BioScanner Cholesterol, HDL Cholesterol and Triglycerides Test Strips from Polymer Technology Systems

Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: K972669, K981493, K990247, and K991894

# Similarities and Differences between BioScanner Plus and the Predicate Device

# Similarities

- Both systems determine Total Cholesterol, HDL Cholesterol, and ● Triglycerides concentrations in whole blood.
- Both systems use the same method of red blood cell separation. .
- Both systems use the same reaction membranes for blood separation and . color development.
- Both systems use a reflectance photometer to convert the intensity of color ● produced in a colorimetric chemical reaction into total cholesterol, HDL cholesterol, and Triglycerides results.
- . Both systems contain a lot specific electronically erasable programmable read-only memory (EEPROM) chip in the same package with the strips. The EEPROM chip has the curve information programmed into it based on a multipoint curve that is established for each lot. The user inserts this chip into the meter with each new lot of test strips.
- t Both systems contain, on the EEPROM, the failsafe feature ensuring that the test strip lot and calculation EEPROM match. If the EEPROM and strip lot number do not match, an error message is displayed.

# Differences

- 1. The BioScanner Test System (K972669) has three optical windows
The BioScanner Plus has four optical windows.

- 2. The BioScanner Test System Cholesterol (K981493), HDL Cholesterol (K990247) and Triglycerides (K991894) Test Strips are constructed on three separate strips. The Lipid Panel Test Strips combine the cholesterol, HDL cholesterol and triglycerides into one test strip.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

OCT 22 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. James M. Connolly, CEO Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268

Re: k013173

Trade/Device Name: BioScanner Plus and Lipid Panel Test Strips Regulation Number: 21 CFR 862.1175, 21 CFR 862.1475, 21 CFR 862.1705 Regulation Name: Cholesterol (total) test system, Lipoprotein test system, Triglyceride test system Regulatory Class: Class I, reserved, Class I, reserved, Class I, reserved Product Code: CHH, LBR, JGY Dated: September 11, 2001 Received: September 24, 2001

Dear Mr. Connolly:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will and w you diving of substantial equivalence of your device to a legally marketed noutication. The I Drivinant of Scation for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 If you desire specific datable for your ostic devices), please contact the Office of Compliance at additionally 607.10 for questions on the promotion and advertising of your device, [phone]. Tradition for at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilites under the Act may be obtained from the Division of Small mornation on your respondiationsumer Assistance at its toll-free number [phone] or Manufacturers International and Selecss "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Page

510 (K) NUMBER (IF KNOWN) : _ KU13173

BioScanner Plus and Lipid Panel Test Strips DEVICE NAME:

INDICATIONS FOR USE:

The Lipid Panel Test Strips are intended to measure cholesterol and triglycerides in whole blood on a BioScanner Plus analyzer. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism , or various endocrine disorders.

The BioScanner Plus is intended to be used by healthcare professionals to measure blood analytes on a test strip.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Fer 21 CFR 801.109)

OR

Over-The-Counter-Use er-The-Councer 33-96)

Kesia Alexander for Tim Cooper

(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K013173

2