BIOSCANNER PLUS

K014099 · Polymer Technology Systems, Inc. · NBW · Dec 21, 2001 · Clinical Chemistry

Device Facts

• Record ID: K014099
• Device Name: BIOSCANNER PLUS
• Applicant: Polymer Technology Systems, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 21, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The BioScanner Plus Glucose Test Systems are intended for the quantitative determination of glucose in human whole blood for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing and individuals at home. 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.

Device Story

BioScanner Plus is an in vitro diagnostic device combining reflectance photometry and amperometry. It accepts human whole blood samples applied to specific dry-phase test strips. The device processes these samples to measure glucose levels; it integrates the reflectance technology of the BioScanner Plus (K013173) and the amperometric technology of the BioScanner Beyond Glucose Analyzer (K013203) into a single unit. Used in clinical settings (physician offices, bedside) and home environments by professionals or patients. Output is a quantitative glucose measurement displayed to the user, facilitating diagnosis and management of carbohydrate metabolism disorders.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison and bench testing of the combined reflectance and amperometric circuits.

Technological Characteristics

In vitro diagnostic device; reflectance photometer and amperometer; dry-phase test strips; Class II; 21 CFR 862.1345.

Indications for Use

Indicated for quantitative glucose determination in human whole blood. Used by healthcare professionals in physician offices, acute/convalescent care facilities, and by individuals at home for diagnosis/treatment of diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

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

• BioScanner Plus (K013173)
• BioScanner 2000 (K972669)
• BioScanner Beyond Glucose Analyzer (K013203)

Submission Summary (Full Text)

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# SECTION F: 510(k) Summary

K014099

### 510(k) SUMMARY

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

- Application Date: 1.
DEC 2 1 2001

#### Applicant Information: 2.

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

December 7, 2001

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

#### Trade Names: 3.

BioScanner Plus BioScanner Glucose Test Strips BioScanner Beyond Glucose Test Strips

#### Description 4.

The BioScanner Plus, as modified, is an in vitro diagnostic device consisting of both a reflectance photometer and an amperometer. This device measures various analytes in blood once the blood is applied to dry phase test strips that are specifically designed for reflectance or amperometric analysis. The test strips have not been modified.

The unmodified BioScanner Plus contains a reflectance photometer. The modified BioScanner Plus has an additional amperometric circuit.

#### Classification Names: ನ.

Glucose Test System Panel: Clinical Chemistry 75 Product Codes: CGA, NBW

- Facility Address: 6. 7736 Zionsville Road Indianapolis, IN 46268
- Device Classification: Class II (Regulation: 21 CFR 862.1345) 7.

#### Intended Use: 8.

The BioScanner Plus Glucose Test Systems are intended for the quantitative determination of glucose in human whole blood for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing and individuals at home. 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.

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

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#### Predicate Device Information 10.

ate Device Innormation
The following table lists the predicate devices for this submission for
determination of substantial equivalence:

| New Device | Predicates | K Numbers |
|------------------------------|----------------------------------------|-----------|
| Modified BioScanner<br>Plus* | BioScanner Plus* | K013173 |
| | BioScanner 2000* | K972669 |
| | BioScanner Beyond Glucose<br>Analyzer* | K013203 |

*Device Company: Polymer Technology Systems

## Similarities and Differences

...

| Items Compared | Similarities | Differences |
|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Modified BioScanner Plus<br>to BioScanner Plus<br>(K013173) | 1. Both include all the same<br>features and technology<br>(reflectance photometry) to<br>run colorimetric tests. | The modified device<br>combines two predicate<br>devices. It combines the<br>amperometric BioScanner<br>Beyond Glucose Analyzer<br>(K013203) with the<br>reflectance photometer in the<br>BioScanner Plus (K013173)<br>and incorporates them into a<br>single device. |
| 2. Modified BioScanner Plus<br>to BioScanner Beyond<br>Glucose Analyzer (K013203) | 2. Both include all the same<br>features and technology (to<br>run amperometric tests). | |
| Test strips used with<br>modified BioScanner Plus | | |
| 3. BioScanner Glucose Test<br>Strips (colorimetric test<br>strips:K972669) | 3. Same test strip used on<br>modified BioScanner<br>Plus as on BioScanner<br>Plus and BioScanner. | 3. None. |
| 4. BioScanner Beyond<br>Glucose Test Strips<br>(amperometric test strips,<br>K013203) | 4. Same test strip used on<br>modified BioScanner<br>Plus as on BioScanner<br>Beyond Glucose<br>Analyzer | 4. None. |
| Intended Use: Modified<br>device compared to<br>unmodified | Same intended use. | None |

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 1 2001

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

k014099 Re: Trade/Device Name: BioScanner Plus for Professional and OTC Use Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: December 7, 2001 Received: December 13, 2001

Dear Ms. Enright:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) 70 ttg enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1977 , is accordance with the provisions of the Federal Food, Drug, devices that have occh resuire 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, diererore, manovate a et include requirements for annual registration, listing of general controls provactice, 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 If your device is elaboried too as controls. Existing major regulations affecting your device can may or subject to about areas Regulations, Title 21, Parts 800 to 898. 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 that I Drivial statutes and regulations administered by other Federal agencies. You must or any I out all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set el It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quarty of crovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Center for Devices and Radiological Health

510(k) Number (if known): HO14099

Device Name: BioScanner Plus for Professional and OTC Use

Indications for Use:

The BioScanner Plus Glucose Test Systems are intended for the quantitative determination of glucose in human whole blood for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing and individuals at home. 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.

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Lices
510(k) Number K014099

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-CounterUse

(Optional Format 1-2-96)