PTS PANELS LIPID PANEL TEST STRIPS

K023558 · Polymer Technology Systems, Inc. · CHH · Nov 15, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023558
• Device Name: PTS PANELS LIPID PANEL TEST STRIPS
• Applicant: Polymer Technology Systems, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Nov 15, 2002
• 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 (CardioChek brand) analyzer. Lipid measurements are used in the diagnosis and treatment of lipoprotein metabolism and lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is designed for use by healthcare professionals and individuals for personal use at home.

Device Story

Lipid Panel Test Strips consist of plastic holders with chemically treated membranes; designed for in vitro diagnostic use. Input: whole blood sample applied to strip. Operation: membranes isolate red blood cells; serum/plasma reacts with chemicals to produce color change. Output: color intensity measured by BioScanner Plus (CardioChek) reflectance photometer. Used by healthcare professionals or patients at home. System uses lot-specific EEPROM chip inserted into meter to calibrate results based on multipoint curves. Output provides quantitative lipid concentrations; assists clinicians in diagnosing/managing lipid disorders, atherosclerosis, and metabolic diseases. Benefits patients through convenient, rapid lipid monitoring.

Clinical Evidence

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

Technological Characteristics

Dry phase test strips; plastic holder with chemically treated membranes. Reflectance photometry sensing principle. Calibrated via lot-specific EEPROM chip. Compatible with BioScanner Plus (CardioChek) analyzer. No electronic components on strip itself; relies on external photometer for signal processing.

Indications for Use

Indicated for healthcare professionals and individuals for home use to measure cholesterol, HDL cholesterol, and triglycerides in whole blood. Used for diagnosis and treatment of lipoprotein metabolism disorders, atherosclerosis, diabetes mellitus, nephrosis, liver obstruction, and various liver, renal, and endocrine diseases.

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 (PTS PANELS) Cholesterol Test Strips (K990688)
• BioScanner (PTS PANELS) HDL Cholesterol Test Strips (K993377)
• BioScanner (PTS PANELS) Triglycerides Test Strips (K000586)

Submission Summary (Full Text)

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# SECTION F: 510(k) Summary

023558

## 510(k) SUMMARY

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

- 1. Application Date: October 21, 2002
- 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: mme(@diabetes-testing.com

# NOV 1 5 2002

- 3. Trade Names:
PTS PANELS Lipid Panel Test Strips

- 4. Description:
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 membrane and react to produce a color change. The Lipid Panel Test Strips are for in vitro diagnostic use with a BioScanner Plus (CardioChek brand) reflectance photometer.

#### ನ. Classification Names:

Cholesterol test system Lipoprotein test system Panel: Clinical Chemistry 75 Product Codes: CHH, LBR, JGY

#### 6. Facility Address:

7736 Zionsville Road Indianapolis, IN 46268

#### 7. Device Classification:

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

#### 8. Intended Use:

The Lipid Panel Test Strips are intended to measure cholesterol, HDL cholesterol and triglycerides in whole blood on a BioScanner Plus (CardioChek brand) analyzer. Lipid measurements are used in the diagnosis and treatment of lipoprotein metabolism and lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is designed for use by healthcare professionals and individuals for personal use at home.

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

Device Modification

#### 10. Predicate Device Information

The predicate devices for determination of substantial equivalence are: Name: BioScanner (PTS PANELS) Cholesterol, HDL Cholesterol and Triglycerides Test Strips Device Company: Polymer Technology Systems. Inc.

510(k) Numbers: K990688, K993377, K000586

# Similarities and Differences between PTS Lipid PANELS Test Strips and the Predicate Devices

### Similarities

- Both systems are designed for home use (OTC).
- 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.

### Differences

- The BioScanner (PTS PANELS) Test System Cholesterol (K990688), HDL . Cholesterol (K993377) and Triglycerides (K000586) are constructed on three separate test strips.
The Livid Panel Test Strips combine cholesterol, HDL and triglycerides on one test strip.

- The Lipid Panel Test Strips may be used on the BioScanner Plus, which is ● marketed under the CardioChek brand name, instrument, but not on the BioScanner 2000.
The BioScanner (PTS PANELS) Cholesterol, HDL Cholesterol and Triglycerides Test Strips may be used on both the BioScanner 2000 and the BioScanner Plus (CardioChek brand) instruments.

### 11. Compliance with Special Controls

### Does not apply.

I Q

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the address of the Food and Drug Administration. The address is 2098 Gaither Road, Rockville MD 20850. The text is black and the background is white.

Ms. Margo Enright Manager of Clinical Affairs Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268

Re: k023558

> Trade/Device Name: Lipid Panel Test Strips Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class I Product Code: CHH; JGY; LBR Dated: October 21, 2002 Received: October 23, 2002

Dear Ms. Enright:

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.

NOV 1 5 2002

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.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrlvdsma/dsmamain.html".

Sincerely yours,

Steven Putman

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

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(US: Food and Drug Administration - Center for Devices and Radiological Health

510(k) Number (if known): K023558

Device Name: Lipid Panel Test Strips

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Indications for Use:

The Lipid Panel Test Strips are intended to measure cholesterol and triglycerides in whole blood on a BioScanner Plus (CardioChek brand) analyzer. The test strips are intended to be used by healthcare professionals and individuals at home to measure three blood analytes: cholesterol, HDL cholesterol and triglycerides. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood 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.

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510(k) Num. K023558

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OTC and RX

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