PTS PANELS LDL CHOLESTEROL TEST STRIPS

K040693 · Polymer Technology Systems, Inc. · MRR · Jul 6, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040693
• Device Name: PTS PANELS LDL CHOLESTEROL TEST STRIPS
• Applicant: Polymer Technology Systems, Inc.
• Product Code: MRR · Clinical Chemistry
• Decision Date: Jul 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

PTS PANELS LDL Cholesterol Test Strips provide a quantitative measurement of LDL (low density lipoprotein) cholesterol in whole blood. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This system is intended for professional use.

Device Story

PTS PANELS LDL Cholesterol Test Strips are dry-reagent test strips used for the quantitative determination of LDL cholesterol in human whole blood (fingerstick, EDTA, or heparinized venous). The device utilizes a colorimetric enzymatic assay principle where surfactants inhibit non-LDL lipoproteins. The test strip is inserted into a reflectance photometer (instrumentation required) which measures the color change resulting from the enzymatic reaction. The system is intended for professional use in clinical settings. By providing rapid LDL cholesterol measurements from whole blood, the device assists clinicians in the diagnosis and management of lipid disorders, atherosclerosis, and associated metabolic or organ-specific diseases.

Clinical Evidence

No clinical data provided; substantial equivalence is based on analytical performance comparisons between the dry-reagent test strip system and the predicate wet-reagent photometric assay.

Technological Characteristics

Dry-reagent test strip format; colorimetric enzymatic assay; reflectance photometry sensing principle. Requires external reflectance photometer for measurement. Intended for professional use with whole blood samples.

Indications for Use

Indicated for the quantitative determination of LDL cholesterol in human whole blood to aid in the diagnosis and treatment of lipid disorders, atherosclerosis, and liver/renal diseases. Intended for professional use.

Regulatory Classification

Identification

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Predicate Devices

• Roche LDL-C-Plus (k974733)

Submission Summary (Full Text)

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K040693

### SECTION E: 510(k) SUMMARY

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

March 12, 2004

### Submitter 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

Trade Name: PTS PANELS LDL Cholesterol Test Strips

Common Name: Lipoprotein test system

Panel: Clinical Chemistry 75

Product Code: MRR

Device Classification: Class I

PTS PANELS LDL Cholesterol Test Strips are classified as a Class I device under Clinical Chemistry Systems - Lipoprotein Test System, 21CFR 862.1475.

#### Predicate Device Information

#### STATEMENT OF SUBSTANTIAL EQUIVALENCE

Polymer Technology Systems, Inc., intends to introduce into commercial distribution the PTS PANELS LDL Cholesterol Test Strips for the quantitative determination of LDL cholesterol in human whole blood. PTS PANELS LDL Cholesterol Test Strips are substantially equivalent to the predicate device noted below.

Name: Device Company: 510(k) Number:

LDL-C Plus Roche Diagnostics K974733

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## Similarities and Differences (Predicate and New Device)

.

| Item | Predicate- Roche LDL-C Plus<br>(K974733) | New Device- PTS PANELS<br>LDL Cholesterol Test Strip |
|---------------------|-------------------------------------------------------------------------------|------------------------------------------------------|
| Intended Use | Direct quantitative determination<br>of LDL Cholesterol | Same |
| Test Principle | Colorimetric enzymatic assay<br>using surfactants as inhibitors of<br>non-LDL | Same |
| Sample Requirements | Fasting and non-fasting | Same |

### Differences

| Item | Predicate- Roche LDL-C Plus | New Device- PTS PANELS<br>LDL Cholesterol Test Strip |
|-----------------------------|-----------------------------|-----------------------------------------------------------------|
| Sample Type | Serum or Heparinized Plasma | Whole Blood (Fingerstick and<br>EDTA and Heparinized<br>Venous) |
| Form | Wet (Liquid) | Dry (Test Strip) |
| Instrumentation<br>Required | Absorbance Photometer | Reflectance Photometer |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, topped with a pair of wings.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 6 2004

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

Re: k040693 Trade/Device Name: PTS PANELS LDL Cholesterol Test Strips Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: MRR Dated: June 21, 2004 Received: June 22, 2004

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.

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,

Jann M. Cooper, US, DVM.

Jean M. Cooper, MS, D.V.M. 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

510(k) Number (if known): K040693

Device Name: PTS PANELS LDL Cholesterol Test Strips

Indications For Use:

PTS PANELS LDL Cholesterol Test Strips are intended to measure low density lipoprotein. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

This system is intended for professional use.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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

Office of In Vitro Dlagnostic Device Evaluation and Se

510(k) K040693

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