PTS PANELS CHOL+GLU TEST PANEL

K041750 · Polymer Technology Systems, Inc. · NBW · Jul 23, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041750
• Device Name: PTS PANELS CHOL+GLU TEST PANEL
• Applicant: Polymer Technology Systems, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 23, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED.

Device Story

Modified test strip for simultaneous measurement of total cholesterol and glucose; combines functionality of previously cleared single-test strips (K972669, K981493, K013068). Used with Polymer Technologies Systems BioScanner devices. Operates via established biochemical sensing technology; no change to fundamental scientific technology. Intended for clinical or professional use to provide diagnostic data for patient management. Modification verified through FMEA risk analysis and design control activities per 21 CFR 820.30.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Dry-phase test strip; plastic holder with chemically treated membranes. Enzymatic chemistry: glucose oxidase (glucose) and cholesterol esterase/oxidase (cholesterol). Reflectance photometry sensing. Calibration via EEPROM chip. Compatible with BioScanner Plus (CardioChek) analyzer. Specimen: whole blood (fingerstick or venous).

Indications for Use

Indicated for the measurement of total cholesterol and glucose levels in blood samples, consistent with previously cleared single-test strip indications.

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

• Polymer Technologies Systems BioScanner 1000/BioScanner G Test Strips (K972669)
• Polymer Technologies Systems BioScanner C Test Strip (K981493)
• Polymer Technologies Systems BioScanner Glucose Test Strips (K013068)

Submission Summary (Full Text)

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APR 4 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

k041750 Re: Trade/Device Name: Cho+Glu Test Panel Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, CHH Dated: March 23,2005 Received: March 28,2005

Dear Ms. Enright:

This letter corrects our substantially equivalent letter of June 25, 2004 regarding the indications for is for your device. These types of devices are cleared for management of carbohydrate metabolism disorder and not for diagnosis of such disorders.

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/industry/support/index.html

Sincerely yours,

Jean M. Cooper MS, DUM

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): K041750

Device Name: Chol+Glu Test Panel

Indications For Use:

The Chol+Glu Test Panel is intended to measure cholesterol and glucose 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 blood cholesterol and glucose. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Glucose measurements are used in the management of carbohydrate metabolism disorders.

Prescription Use_ × (Part 21 CFR 801 Subpart D) ANDVOR

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)

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K041750

# JUL 2 3 2004

## 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:

June 25.2004

#### Applicant Information: 2.

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 Names:

PTS PANELS Chol+Glu Test Panel

#### 4. Description:

The Chol+Glu Test Panel is a dry phase test strip that is constructed from a plastic ship holder that holds chemically heated membranes. When whole blood is placed on the test ship, 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 Chol+Glu Test Panel is for in vitro diagnostic use with a CardioChek brand (BioScanner Plus) reflectance photometer.

#### 5. Classification Names:

Cholesterol test system Glucose test system Panel: Clinical Chemistry 75 Product Codes: CHH, CGA

- 6. Facility Address:
7736 Zionsville Road Indianapolis, IN 46268

#### 7. Device Classification:

Class I (Regulations: 21 CFR 862.1345 and 862.1175)

#### Intended Use: 8.

The Chol+Glu Test Panel is intended to measure cholesterol and glucose in whole blood on a CardioChek brand analyzer. The test strips are intended to he used by healthcare professionals to measure blood cholesterol and glucose. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. 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.

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- 9. Reason for 510(k): Device Modification
- Predicate Device Information 10.

The predicate devices for determination of substantial equivalence are: Name: BioScanner (PTS PANELS) Cholesterol and Glucose Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: K972669, K981493, K013068

Similarities and Differences between Chol+Glu Test Panel and the Predicate Devices:

| Item | Predicates | Modified Device |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Intended Use | Intended to measure glucose<br>and cholesterol in whole<br>blood. | Same |
| Technology | Dry chemistry test strip for<br>use with PTS reflectance<br>photometer. | Same |
| Measuring<br>Ranges | Cholesterol: 100-400 mg/dL<br>Glucose: 20-600 mg/dL | |
| Product<br>Storage | Store in cool dry place at<br>room temperature of 68-86°F. | Same |
| Specimen | Whole blood from fingerstick<br>or venous blood collected in<br>EDTA or heparin tube. | Same |
| Chemistry<br>Methods | Glucose oxidase method for<br>glucose and enzymatic<br>(cholesterol esterase /<br>oxidase) trinder method for<br>cholesterol. | Same |
| Calibration<br>Curve | Resides on a read-only<br>memory (EEPROM) chip<br>packaged with the test strips. | Same |

### Similarities Between Predicate and Modified Device

Differences Between Predicate and Modified Pevice

| Item | Predicates | Modified Device |
|------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Number of<br>analytes per<br>test strip. | One test per strip. Separate<br>cholesterol single test strip<br>and separate glucose test<br>strip. | Modified device<br>combines<br>cholesterol and<br>glucose into single<br>test strip. |