URISYS 2400 URINE TEST STRIP

K012397 · Roche Diagnostics Corp. · JIL · Sep 26, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012397
• Device Name: URISYS 2400 URINE TEST STRIP
• Applicant: Roche Diagnostics Corp.
• Product Code: JIL · Clinical Chemistry
• Decision Date: Sep 26, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Intended Use

For semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketone bodies, urobilinogen, bilirubin and blood in urine by reflectance photometry with the Urisys 2400 photometer.

Device Story

Urisys 2400 Urine Test Strips are reagent-impregnated plastic strips used with the Urisys 2400 photometer for automated urinalysis. The system measures reflectance of test pads to determine concentrations of pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and blood. The device also performs intrinsic color compensation by reading a compensation pad to account for urine color and clarity. The system is designed for clinical use; urine samples are dispensed onto the test strip, which is then processed by the photometer. Results are provided to healthcare providers to assist in clinical decision-making regarding patient health status. The device offers improved on-instrument storage (14 days) compared to the predicate.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristics comparing the subject device to the predicate.

Technological Characteristics

Reagent test paper, mesh, and absorbent paper laminated on a plastic strip. Operates via reflectance photometry. Features intrinsic color compensation using a compensation pad. Designed for use with the Urisys 2400 photometer. Storage at 2°C-30°C.

Indications for Use

Indicated for semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketone bodies, urobilinogen, bilirubin, and blood in urine using the Urisys 2400 photometer.

Regulatory Classification

Identification

A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

Predicate Devices

• Roche Diagnostics Chemstrip 10 S-UA test strips (K934042)

Submission Summary (Full Text)

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K012397

# SEP 2 6 2001

| 510(k) Summary | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
| Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Road<br>Indianapolis, IN 46250<br>(317) 576 - 3544<br>Contact Person: Kay A. Taylor<br>Date Prepared: July 25, 2001 |
| Device Name | Proprietary name: Urisys 2400 Urine Test Strip<br>Common name: Reagent Strip for Urinalysis<br>Classification name: Urinary glucose, ketones, nitrite, protein, blood, bilirubin, urobilinogen, leukocytes (non-quantitative) and pH Test Systems |
| Device Description | The Urisys 2400 Urine Test Strips are used in conjunction with the Urisys 2400 photometer. The Urisys 2400 photometer is an automated urinalysis system, class I exempt device, regulation number 21CFR 862.2900. The Urisys 2400 photometer determines specific gravity, sample color, and sample clarity and reflectance measurements of test parameters on the Urisys 2400 Urine Test Strips. |

:

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# 510(k) Summary, Continued

| Intended use | For semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketone bodies, urobilinogen, bilirubin and blood in urine by reflectance photometry with the Urisys 2400 photometer. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | For semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketone bodies, urobilinogen, bilirubin and blood in urine by reflectance photometry with the Urisys 2400 photometer. |
| Substantial Equivalence | The Urisys 2400 Urine Test Strip is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the Roche Diagnostics Chemstrip 10 S-UA test strips (K934042). Both products are designed to provide semi-quantitative urinalysis results using chemistry reagent strips that include pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin and blood reagent pad areas. |

Substantial equivalence similarities

The following table compares the Urisys 2400 Urine Test Strip with the predicate device.

| Feature | Urisys 2400 Urine Test<br>Strip | Chemstrip 10 S-UA |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For semi-quantitative<br>determination of pH,<br>leukocytes, nitrite, protein,<br>glucose, ketone bodies,<br>urobilinogen, bilirubin and<br>blood in urine by<br>reflectance photometry<br>with the Urisys 2400<br>photometer. | For the semi-quantitative<br>determination of Specific<br>Gravity, pH, Leukocytes,<br>Nitrite, Protein, Glucose,<br>Ketones, Urobilinogen,<br>Bilirubin and Blood in urine.<br>Intended for use visually or on<br>the Chemstrip Super UA<br>Automated Urine Analyzer. |
| Architecture | Reagent test paper, mesh<br>and absorbent paper<br>laminated on plastic strip. | Reagent test paper, mesh and<br>absorbent paper laminated on<br>plastic strip. |
| Calibration<br>method | Same | Calibration strips with specific<br>reflectance values for<br>calibration. |
| Storage | Store at 2°C-30°C. | At temperatures below 30°C,<br>do not freeze. |

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### 510(k) Summary, Continued

#### Substantial equivalence similarities, continued

| Feature | Urisys 2400 Urine Test<br>Strip | Chemstrip 10 S-UA |
|---------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Intrinsic color<br>compensation | Same | blank compensation pad<br>correction |
| Measurement<br>mode | Same, as well as urine<br>color through reflectance<br>readings of the<br>compensation pad | photometric reflectance for pH,<br>leukocytes, nitrite, protein.<br>glucose, ketones, urobilinogen,<br>bilirubin, erythrocytes |

#### Substantial equivalence differences

The following table compares the Urisys 2400 Urine Test Strips with the predicate device.

| Feature | Urisys 2400 Urine<br>Test Strips | Chemstrip 10 S-UA |
|-----------------------|-------------------------------------|----------------------------------|
| On-instrument storage | 14 days | up to 10 hours |
| Urine application | Sample dispensed onto<br>test strip | Test strip dipped into<br>sample |

Substantial equivalence performance characteristics The performance characteristics of the Urisys 2400 Urine Test Strips and the predicate device are provided in section IV.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 6 2001

Ms. Kay A. Taylor Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: k012397

> Trade/Device Name: Urisys 2400 Urinalysis Test System Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: ЛО Dated: July 25, 2001 Received: July 27, 2001

Dear Ms. Taylor:

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 the Code of Federal 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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to begin marketing your device of your device to a legally marketed nouncedion. The PDA imania of successification 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 If you desire specific advice for your do the can and one of the Office of Compliance at additionally 607.10 for in This diaglestions on the promotion and advertising of your device, [phone]. Additional J. For quice 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 information on your responsionals. and Consumer Assistance at its toll-free number [phone] or Manufacturers International and Sollass "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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## Indications for Use Statement

510(k) Number (if known): NAA KO/2397

Device Name: Urisys 2400 Urinalysis Test System

Indications For Use:

For semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketone bodies, urobilinogen, bilirubin and blood in urine by reflectance photometry with the Urisys 2400 photometer.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _

(Optional Format 1-2-96)

Kesia Alexander Jordan Cooper
Division Sign Off

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012397

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