COBAS U411 TEST SYSTEM

K093555 · Roche Diagnostics · KQO · Apr 2, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093555
• Device Name: COBAS U411 TEST SYSTEM
• Applicant: Roche Diagnostics
• Product Code: KQO · Clinical Chemistry
• Decision Date: Apr 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2900
• Device Class: Class 1

Intended Use

The cobas u 411 urine analyzer is a semi-automated, benchtop analyzer which is designed to read the Chemstrip 10 UA (Combur' Test M) test strips for urinalysis for the measurement of bilirubin, blood, glucose, ketone, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen and color (if selected). These measurements are useful in the evaluation of renal, urinary and metabolic disorders. Tests performed using the cobas u411 are intended for prescription, in vitro diagnostic use only.

Device Story

The cobas u 411 is a semi-automated, benchtop urinalysis system operated by healthcare professionals in clinical settings. It processes Chemstrip 10 UA reagent strips after manual immersion in urine samples. The device utilizes reflectance photometry with LED light sources (620nm, 555nm, 470nm) and 11 wide-range photo sensors to measure color changes on the test pads. It includes an intrinsic color compensation feature using a non-impregnated area of the strip. The system provides semi-quantitative results for 10 analytes plus color, which are displayed or output via optional formats. Results assist clinicians in evaluating renal, urinary, and metabolic disorders. Data management includes result memory and USB-based storage.

Clinical Evidence

Bench testing only. The device was validated through comparative performance testing against the predicate Chemstrip Urine Analyzer, confirming equivalent reflectance photometry measurements and analytical performance for all 10 urine analytes.

Technological Characteristics

Reflectance photometry; light source: LEDs (620nm, 555nm, 470nm); detector: 11 wide-range photo sensors. Bench-top form factor. Connectivity: USB for data storage, barcode scanner interface. Calibration: gray plastic calibration strip with known reflectance values. Software: embedded firmware for signal processing and result conversion.

Indications for Use

Indicated for prescription, in vitro diagnostic use in clinical settings to measure urine analytes (bilirubin, blood, glucose, ketone, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, and color) to aid in the evaluation of renal, urinary, and metabolic disorders.

Regulatory Classification

Identification

An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

Predicate Devices

• Roche Chemstrip Urine Analyzer (k921087)

Submission Summary (Full Text)

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1093555 APR - 2 2010

## 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>[phone]<br><br>Contact Person: Jennifer Tribbett<br>Date Prepared: March 24, 2010 |
| Device Name | Proprietary name: (1) Chemstrip 10 UA<br>(2) cobas u 411 Urine Analyzer<br><br>Common name: (1) Reagent Strip for urinalysis<br>(2) Automated Urinalysis System<br><br>Classification name: (1) Urinary glucose, ketones, nitrite, protein, blood, bilirubin, urobilinogen, leukocytes, pH and specific gravity<br>(2) Automated Urinalysis System |

The FDA has classified the devices as follows; Classification

| Classification Name | Classification Number | Panel Name | Exempt | Device Class | Regulation Citation |
|-----------------------------------------------------------|-----------------------|-----------------------|--------|--------------|---------------------|
| Method, enzymatic, glucose<br>(urinary, non-quantitative) | JIL | 75 Clinical Chemistry | NO | II | 21 CFR 862.1340 |
| Blood, occult, colormetric, in urine | JIO | 82 Hematology | NO | II | 21 CFR 864.6550 |

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| Classification Name | Classification<br>Number | Panel Name | Exempt | Device<br>Class | Regulation<br>Citation |
|--------------------------------------------------------------|--------------------------|--------------------------|--------|-----------------|------------------------|
| Diazonium Colorimetry,<br>urobilinogen (urinary, non-quant) | CDM | 75 Clinical<br>Chemistry | YES | I | 21 CFR<br>862.1785 |
| Dye-Indicator, pH (Urinary, non-<br>quant) | CEN | 75 Clinical<br>Chemistry | YES | I | 21 CFR<br>862.1550 |
| Nitroprusside, ketones (urinary, non-<br>quant) | JIN | 75 Clinical<br>Chemistry | YES | I | 21 CFR<br>862.1435 |
| Indicator method, protein or albumin<br>(urinary, non-quant) | JIR | 75 Clinical<br>Chemistry | YES | I | 21 CFR<br>862.1645 |
| Diazo (colormetric), Nitrite<br>(Urinary, non-quant) | JMT | 75 Clinical<br>Chemistry | YES | I | 21 CFR<br>862.1510 |
| Test, Urine Leukocyte | LJX | 82<br>Hematology | YES | I | 21 CFR<br>864.7675 |
| Azo-dyes, colormetric, bilirubin &<br>its con | JJB | 75 Clinical<br>Chemistry | YES | I | 21 CFR<br>862.1115 |
| Automated Urinalysis System | KQO | 75 Clinical<br>Chemistry | YES | I | 21 CFR<br>862.2900 |
| Refractometer for clinical use | JRE | 75 Clinical<br>Chemistry | YES | I | 21 CFR<br>862.2800 |

The cobas u 411 urinalysis test system is substantially equivalent to Substantial other devices legally marketed in the United States. We claim equivalence equivalence to the Chemstrip Urine Analyzer (K921087 and K931602). Both instruments are designed to provide semi-quantitative results using a reagent strip that includes test pads for determination of pH, leukocytes, blood, nitrite, protein, glucose, ketone, urobilinogen, bilirubin, and specific gravity. The cobas u 411 urine analyzer is a semi-automated, benchtop analyzer Device which is designed to read Chemstrip 10 UA (Combur10 Test M) test Description strips for urinalysis for the measurement of bilirubin, blood, glucose, ketone, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen and color (if selected). These measurements are useful in the evaluation of renal, urinary and metabolic disorders. Tests performed using the cobas u411 are intended for prescription, in vitro diagnostic use only. The functions of the cobas u 411 analyzer includes: o Sample identification (with optional barcode scanner) o Controlled incubation period o Photometric measurements o Result memory o Optional formats for data output

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The following table compares the cobas u 411 urinalysis test system Comparative with the predicate device. These represent the features that are the Tables same for both systems.

| Feature | Chemstrip Urine Analyzer<br>(predicate) | cobas u 411 urinalysis test system<br>(proposed) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Chemstrip Urine Analyzer is a<br>semiautomated, computerized analyzer<br>intended for the in vitro semi-<br>quantitative determination of urine<br>analytes, including specific gravity<br>(SG), pH, leukocytes, nitrite, protein,<br>glucose, ketones, urobilinogen,<br>bilirubin and erythrocytes<br><br>Note: A compensation pad is provided<br>to aid in the correction of interference<br>from the intrinsic color of urine. | The cobas u 411 urine analyzer is a<br>semi-automated, benchtop analyzer<br>which is designed to read Chemstrip 10<br>UA (Combur10 Test M) test strips for<br>urinalysis for the measurement of<br>bilirubin, blood, glucose, ketone,<br>leukocytes, nitrite, pH, protein, specific<br>gravity, urobilinogen and color (if<br>selected). These measurements are<br>useful in the evaluation of renal,<br>urinary and metabolic disorders. Tests<br>performed using the cobas u411 are<br>intended for prescription, in vitro<br>diagnostic use only. |
| Analyzer<br>Technology | Reflectance photometry | Same |
| Light Source | LEDs | Same |
| Reagent Strip | Chemstrip 10 UA test strip | Same |
| Urine<br>application | Test strip dipped into urine sample | Same |
| Intrinsic color<br>compensation | The test strip area not impregnated<br>with reagents, allows instrumental<br>compensation for the intrinsic color of<br>the urine while testing. | Same |
| Calibration<br>method | Calibration strips with specific<br>reflectance values for calibration. | Same |
| Feature | Chemstrip Urine Analyzer<br>(predicate) | cobas u 411 urinalysis test system<br>(proposed) |
| Test Principle | pH: color change with the indicators<br>methyl red and bromthymol blue.<br><br>Leukocytes: esterase cleaves an indoxyl<br>ester, and the indoxyl reacts with a<br>diazonium salt to produce a purple color.<br><br>Nitrite: based on the principle of the<br>Griess test. Nitrite, if present, reacts with<br>an aromatic amine to give a diazonium salt<br>which yields a red-violet azo dye.<br><br>Protein: based on the "protein error of pH<br>indicators" involving tetrachlorophenol-<br>tetrabromosulfophthalein<br><br>Glucose: based on the specific glucose<br>oxidase/peroxidase reaction (GOD/POD<br>method).<br><br>Ketone: based on the principle of Legal's<br>test involving use of sodium nitroprusside.<br><br>Urobilinogen: Urobilinogen is coupled<br>with 4-methoxybenzene-diazonium-<br>tetrafluoroborate in an acid medium to<br>form a red azo dye.<br><br>Bilirubin: based on the coupling of<br>bilirubin with a diazonium salt.<br><br>Blood: The peroxidase-like action of hgb<br>and myoglobin catalyzes the oxidation of<br>the indicator by the organic peroxide.<br><br>Specific Gravity: In the presence of<br>cations, protons are released by a<br>complexing agent in the test and produce a<br>color change | Same |
| Feature | Chemstrip Urine Analyzer (predicate) | cobas u 411 urinalysis test system (proposed) |
| Measuring Unit | Light Emitting Diodes (LEDs)<br><br>Wavelength:<br>Orange: 620 nm<br>Green: 555 nm<br>Red: 660 nm<br><br>Reader Head: 2 heads with 3 LEDs each | Light Emitting Diodes (LEDs)<br><br>Wavelength:<br>Orange: 620 nm<br>Green: 555 nm<br>Blue: 470 nm<br><br>Sensor: 11 wide range photo sensors |
| Operating Conditions | Temperature:<br>•operational: 15 - 34 °C<br>•storage: -20 - 60 °C<br><br>Humidity:<br>•operational: 20 - 80%<br>•storage: 20 - 95% | Temperature:<br>•operational: 15 - 32 °C<br>•storage: -25 - 60 °C<br><br>Humidity:<br>•operational: 30 - 80%<br>•storage: 10 - 95% |
| Storage Medium | Floppy Disks | USB Stick |
| Strip Detector | One strip detector | Two strip detectors |

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The following table compares the cobas u 411 urinalysis test system Comparative i with the predicate device. These represent the key features that are Tables different between the two system. ・・

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Roche Diagnostics Corporation c/o Ms. Jennifer Tribbett 9115 Hague Road Indianapolis, Indiana 46250

APR 0 2 2010

Re: k093555

> Trade Name: Cobas u 411 Test System Regulation Number: 21 CFR §862.1340 Regulation Name: Urinary Glucose (non-quantitative test system) Regulatory Class: Class II Product Codes: JIL, JIO, CDM, CEN, JIN, JIR, JMT, JJB, LJX, CEN, JRE, KQO Dated: March 29, 2010 Received: March 30, 2010

Dear Ms. Tribbett:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the qvality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

Courtney C. Harper, Ph.D. 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 Form

510(k) Number (if known):

Device Name: cobas u 411 Urinalysis Test System

Indications For Use:

The cobas u 411 urine analyzer is a semi-automated, benchtop analyzer which is designed to read the Chemstrip 10 UA (Combur' Test M) test strips for urinalysis for the measurement of bilirubin, blood, glucose, ketone, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen and color (if selected). These measurements are useful in the evaluation of renal, urinary and metabolic disorders. Tests performed using the cobas u411 are intended for prescription, in vitro diagnostic use only.

Prescription Use XXX AND/OR (Part 21 CFR 801 Subpart D)

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)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K093555

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