PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS

K070017 · Polymer Technology Systems, Inc. · NBW · Jan 31, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070017
• Device Name: PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS
• Applicant: Polymer Technology Systems, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 31, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The PTS PANELS Metabolic Chemistry Panel Test Strips are intended for the quantitative determination of glucose, HDL cholesterol, and triglycerides in whole blood. The PTS PANELS Metabolic Chemistry Panel Test Strips are intended for use with the PTS PANELS readers. The PTS PANELS Metabolic Chemistry Panel Test Strips are intended for use by healthcare professionals and in point-of-care settings.

Device Story

PTS PANELS Metabolic Chemistry Panel Test Strips utilize dry chemistry technology to measure glucose, HDL cholesterol, and triglycerides from fingerstick whole blood samples. The device consolidates three separate tests into a single test strip, reducing total testing time to approximately two minutes. It is designed for use by medical professionals in clinical settings and by individuals in home environments. The test strips are used with a PTS reflectance photometer, which reads the colorimetric enzymatic reaction results. Calibration data is stored on an EEPROM chip packaged with the strips. The output provides quantitative measurements of glucose, HDL, and triglycerides, assisting healthcare providers in the diagnosis and management of metabolic and lipid-related disorders.

Clinical Evidence

Bench testing only. Performance evaluated through precision studies and comparative analysis against standard laboratory chemistry analyzers to ensure accuracy of the combined metabolic panel.

Technological Characteristics

Multi-assay test strip integrating glucose, HDL cholesterol, and triglyceride chemistries. Operates with PTS PANELS readers. Design control procedures per 21 CFR 820.30 applied. No change to fundamental scientific technology.

Indications for Use

Indicated for quantitative determination of glucose, HDL cholesterol, and triglycerides in whole blood. Intended for use by healthcare professionals in point-of-care settings for patients requiring metabolic monitoring.

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 Glucose Test Strips (K013068)
• PTS PANELS HDL Cholesterol Test Strips (K060617)
• PTS PANELS Triglycerides Test Strips (K991894)
• PTS PANELS Triglycerides Test Strips (K000586)

Submission Summary (Full Text)

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# SECTION F: 510(k) Summary

K070017

### 510(k) SUMMARY

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

- 1. Application Date: December 29, 2006
- 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 Name:

PTS PANELS Metabolic Chemistry Panel Test Strips

#### 4. Classification Names:

Common Name(s): Glucose Test System, Lipoprotein and cholesterol (high density lipoprotein) test systems, Triglyceride Test System Panel: Clinical Chemistry 75 Product Codes: NBW, NAQ, NGO

#### Facility Address: న్.

7736 Zionsville Road Indianapolis, IN 46268

#### 6. Device Classification:

Class 2 (Regulations: 21 CFR 862.1345, 862.1475, 862.1475, 862.1705)

#### 7. Intended Use:

PTS PANELS Metabolic Chemistry Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure glucose, high density lipoprotein cholesterol and triglycerides in fingerstick whole blood. Glucose measurements are used in the management of carbohydrate metabolism disorders. 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.

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

Device Modification

#### 9. Predicate Device Information

The predicate devices for determination of substantial equivalence are: Name: PTS PANELS Glucose, HDL Cholesterol and Triglycerides Test Strips

JAN 3 1 2007

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Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: Glucose: K013068 HDL: K060617 Triglycerides: K991894 and K000586

Similarities and Differences between modified device (PTS PANELS Metabolic Chemistry Test Strips) and the Predicate Device (unmodified- PTS PANELS Glucose, HDL Cholesterol and Triglycerides Test Strips)

| Item | Predicates | Modified Device |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Intended Use | Intended to measure glucose, HDL cholesterol and triglycerides 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 | Glucose: Colorimetric enzymatic (glucose oxidase)<br>HDL: Colorimetric enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol.<br>Triglycerides: Colorimetric enzymatic (cholesterol esterase/ glycerophosphate oxidase) | 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 | Three separate test strips | Single test strip with<br>three tests |
| Time to<br>obtain results | About one minute for each test. | About two minutes<br>for all three test<br>results. |

## 10. Compliance with Special Controls

Does not apply.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Margo Enright Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268

JAN 3 1 2007

Re: k070017

Trade/Device Name: PTS Panels Metabolic Chemistry Panel Test Strips Regulation Number: 21 CFR § 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JGY, LBR, NAQ, NGO Dated: December 29, 2006 Received: January 03, 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, 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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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, 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Yean 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

K010017 510(k) Number (if known):

Device Name: PTS PANELS Metabolic Chemistry Panel Test Strips

PTS PANELS Metabolic Chemistry Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure glucose, high density lipoprotein cholesterol and triglycerides in fingerstick whole blood. Glucose measurements are used in the management of carbohydrate metabolism disorders. 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.

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. Bonsem

Sign-Off

C frice of In Vitro Diagnostic Device Caluation and Safety

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