PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS

K071507 · Polymer Technology Systems, Inc. · NBW · Sep 10, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071507
• Device Name: PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS
• Applicant: Polymer Technology Systems, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 10, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

PTS PANELS CHOL+HDL+GLU Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol. high density lipoprotein cholesterol and glucose 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. Glucose measurements are used by individuals with diabetes to measure glucose in fingerstick whole blood at home for the management of carbohydrate metabolism disorders.

Device Story

PTS PANELS CHOL+HDL+GLU Panel Test Strips; multi-analyte test strip combining three tests (cholesterol, HDL-cholesterol, glucose) into single strip. Input: 35 uL whole blood sample. Operation: user applies sample to strip; device performs colorimetric/enzymatic analysis; results obtained in approximately two minutes. Used in point-of-care settings; operated by healthcare professionals. Output: quantitative concentration values for cholesterol, HDL, and glucose. Modification from previous single-test strips includes increased sample volume (15 uL to 35 uL) and consolidated test format.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing comparing the performance of the integrated single-strip format to the predicate multi-strip system.

Technological Characteristics

Multi-analyte test strip; enzymatic/colorimetric sensing principle; requires 35 uL whole blood sample; test time approximately 2 minutes.

Indications for Use

Indicated for the quantitative determination of cholesterol, HDL-cholesterol, and glucose in whole blood.

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

• PTS PANELS Cholesterol Test Strips (K981493)
• PTS PANELS Cholesterol Test Strips (K990688)
• PTS PANELS HDL Cholesterol Test Strips (K060617)
• PTS PANELS Glucose Test Strips (K013068)

Submission Summary (Full Text)

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# SECTION F: 510(k) Summary

### 510(k) SUMMARY

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

- 1. Application Date: May 30, 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: e-mail: [e-mail]

- 3. Trade Name: PTS PANELS CHOL+HDL+GLU Panel Test Strips
#### 4. Classification Names:

Lipoprotein and cholesterol (high density lipoprotein) test systems and Glucose Test System Panel: Clinical Chemistry 75 Product Codes: NBW, CHH, LBR

#### 5. Facility Address:

7736 Zionsville Road Indianapolis, IN 46268

#### 6. Device Classification:

Class 2 (Regulations: 21CFR 862.1345, 862.1175, 862.1475)

#### 7. Intended Use:

PTS PANELS CHOL+HDL+GLU Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol. high density lipoprotein cholesterol and glucose 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. Glucose measurements are used by individuals with diabetes to measure glucose in fingerstick whole blood at home for the management of carbohydrate metabolism disorders.

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

Device Modification

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#### Predicate Device Information 9.

The predicate devices for determination of substantial equivalence are: Name: PTS PANELS Cholesterol, HDL Cholesterol and Glucose Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: Cholesterol: K981493, K990688 HDL: K060617 Glucose: K013068

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

| Item | Predicates | Modified Device |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Intended Use | Intended to measure cholesterol, HDL cholesterol and glucose in whole blood. | 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 Method | Cholesterol: Colorimetric enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol.<br>HDL: Colorimetric enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol.<br>Glucose: Colorimetric enzymatic (glucose oxidase) | Same |
| Calibration Curve | Resides on a read-only memory (EEPROM) chip packaged with the test strips. | Same |
| Item | Predicates | Modified Device |
| Number of<br>test strips to<br>obtain results | Three separate test strips | Single test strip with<br>three tests |
| Time to | About one minute for each test. | About two minutes |

### Similarities Between Predicate and Modified Device

for all three test

results.

### Compliance with Special Controls 10.

obtain results

Does not apply.

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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 stylized depiction of an eagle or bird-like figure with outstretched wings, positioned above three curved lines that resemble flowing fabric or water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k071507

Trade/Device Name: PTS PANELS CHOL+HDL+GLU Panel Test Strips Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, CHH, LBR Dated: August 13, 2007 Received: August 14, 2007

SEP 1 0 2007

Dear Ms. Enright:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave ro rowed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrease of the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de Hoos mat have a ct (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 r ou may, arovisions 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 it may of casions 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 a legally 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 toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jean M. Coopes, M.S., D.V.M.

Sean 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

510(k) Number (if known): K071507

Device Name: PTS PANELS CHOL+HDL+GLU Panel Test Strips

PTS PANELS CHOL+HDL+GLU Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol, high density lipoprotein cholesterol and glucose 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. Glucose measurements are used by individuals with diabetes to measure glucose in fingerstick whole blood at home for the management of carbohydrate metabolism disorders.

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 Benson

LAvision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K071507

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