PTS PANELS CHOL+HDL PANEL TEST STRIPS

K071593 · Polymer Technology Systems, Inc. · CHH · Oct 15, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071593
• Device Name: PTS PANELS CHOL+HDL PANEL TEST STRIPS
• Applicant: Polymer Technology Systems, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Oct 15, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Intended Use

The PTS PANELS CHOL+HDL Panel Test Strips are intended for the quantitative determination of total cholesterol and HDL cholesterol in whole blood. The PTS PANELS CHOL+HDL Panel Test Strips are intended for use with the CardioChek PA and CardioChek Plus professional analyzers. The system is intended for use by healthcare professionals in a clinical setting.

Device Story

PTS PANELS CHOL+HDL Panel Test Strips combine total cholesterol and HDL cholesterol testing onto single strip; used with CardioChek PA/Plus professional analyzers. Input: 30 uL whole blood sample. Operation: enzymatic reaction on test strip; analyzer measures reflectance/colorimetric change. Output: quantitative cholesterol levels displayed on analyzer screen. Used in clinical settings by healthcare professionals. Modification from predicate: combined two tests into one strip; increased sample volume from 15 uL to 30 uL; increased test time from one to two minutes. Clinical decision-making: results used for lipid profile assessment and cardiovascular risk management.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing comparing the modified single-strip format to the predicate two-strip format.

Technological Characteristics

Enzymatic reflectance-based test strips. Analyte: total cholesterol and HDL cholesterol. Sample: 30 uL whole blood. Test time: 2 minutes. Compatible with CardioChek PA and CardioChek Plus professional analyzers. Design controls per 21 CFR 820.30.

Indications for Use

Indicated for quantitative determination of total cholesterol and HDL cholesterol in whole blood. Intended for use by healthcare professionals in clinical settings using CardioChek PA and CardioChek Plus analyzers.

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

• PTS PANELS Cholesterol test strips (k981493, k990688)
• PTS PANELS HDL Cholesterol test strips (k060617)

Submission Summary (Full Text)

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K07/593

## SECTION F: 510(k) Summary

## CC7 1 5 2007

510(k) SUMMARY

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

- 1. Application Date: September 25, 2007
- 2. Applicant Information: Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268

Contact Person: Margo Enright Phone Number: 317-870-5610 x1064 FAX Number: 317-870-5608 e-mail: [e-mail]

- 3. Trade Name: PTS PANELS CHOL+HDL Panel Test Strips
- 4. Classification Names: Cholesterol (total) test system and Lipoprotein (high density lipoprotein) test system. Panel: Clinical Chemistry 75 Product Codes: CHH, LBR
- 5. Establishment Registration Number: 1836132
- ર્. Facility Address: 7736 Zionsville Road Indianapolis, IN 46268
- 7. Device Classification: Class 1 (Regulations: 21CFR 862.1175 and 862.1475)

#### 8. Intended Use:

PTS PANELS CHOL+HDL Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol and high density lipoprotein cholesterol in whole blood. 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.

- 9. Reason for 510(k):
Device Modification

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### Predicate Device Information 10.

The predicate devices for determination of substantial equivalence are: Name: PTS PANELS Cholesterol Test Strips

PTS PANELS HDL Cholesterol Test Strips

Device Company: Polymer Technology Systems, Inc.

510(k) Numbers:

Cholesterol: K981493, K990688 HDL Cholesterol: K060617

Similarities and Differences between modified device (PTS PANELS CHOL+HDL Panel Test Strips) and the Predicate Device (unmodified- PTS PANELS Cholesterol and PTS PANELS HDL Cholesterol Test Strips)

| Item | Predicate | Modified Device |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Intended Use | Intended to measure cholesterol and HDL cholesterol | Same |
| Technology | Dry chemistry test strip for use with PTS reflectance photometer. | Same |
| Product Storage | Store with vial tightly capped in a cool dry place at room temperature of 68-86°F. | Same |
| Specimen | Whole blood from fingerstick or venous blood collected in an EDTA or heparin tube. | Same |
| Chemistry Methods | Cholesterol: Colorimetric enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol.<br>HDL: Colorimetric enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol. Dextran Sulfate fractionation. | Same |
| Calibration Curve | Resides on a read-only memory (EEPROM) chip packaged with the test strips. | Same |

## Similarities Between Predicate and Modified Device

### Differences Between Predicate and Modified Device

| Item | Predicates | Modified Device |
|-----------------------------------------------|-------------------------------------------|--------------------------------------------|
| Number of<br>test strips to<br>obtain results | Two | One test strip<br>containing two<br>tests. |
| Time to<br>obtain results | About one minute for each test<br>result. | About two minutes. |

### 11. Compliance with Special Controls

Does not apply.

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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 (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 5 2007

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

Re: k071593 Trade/Device Name: PTS Panel CHOL+HDL Panel Test Strips Regulation Number: 21 CFR \$862.1175 Regulation Name: Cholesterol (total) test system. Regulatory Class: Class I Product Code: CHH, LBR Dated: September 25, 2007 Received: September 27, 2007

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. Ilsting 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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Page 2 -

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 10gally marketed predicate device results in a classification for your device and thus, perroits 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 tollifican mumber [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Séan M. Cooper, M.S., 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

k871593 510(k) Number (if known):

Device Name:__PTS PANELS CHOL+HDL Panel Test Strips

PTS PANELS CHOL+HDL Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol and high density lipoprotein cholesterol in whole blood. 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.

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

Over-The-Counter Use X (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
on Sign-Off

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്ലേ of In Vitro Diagnostic Device luation and Safety

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