cobas u 601 urinalysis test system

K183432 · Roche Diagnostics · JIL · May 7, 2019 · Clinical Chemistry

Device Facts

• Record ID: K183432
• Device Name: cobas u 601 urinalysis test system
• Applicant: Roche Diagnostics
• Product Code: JIL · Clinical Chemistry
• Decision Date: May 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Intended Use

The cobas u 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack. The cobas u 601 urine analyzer when used with the cobas u pack is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color, and erythrocytes, as well as clarity. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders. This system is intended to be used by trained operators in clinical laboratories. The cobas u pack is a cassette loaded with cobas u 601 test strips for the in vitro qualitative or semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color, and erythrocytes in urine with the cobas u 601 urine analyzer. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders.

Device Story

The cobas u 601 urinalysis test system is a fully automated clinical laboratory instrument. It processes urine samples loaded in racks; the system aspirates urine and dispenses it onto test pads of cobas u pack test strips. The analyzer uses a reflectance photometer to measure color changes on the test pads and a physical measurement cell (PMC) to assess urine clarity and specific gravity. The system includes an RFID-enabled cassette for test strip management. The analyzer performs automated color correction for specific analytes to compensate for intrinsically colored urine. Results are used by clinicians to evaluate renal, urinary, hepatic, and metabolic disorders. The system provides automated, standardized results, reducing manual handling and visual interpretation errors associated with traditional dipstick methods.

Clinical Evidence

No clinical studies were performed. Evidence consists of analytical performance data, including precision (repeatability and within-laboratory), linearity, analytical sensitivity, and analytical specificity (interference testing). Method comparison studies were conducted against the predicate device using native urine samples, demonstrating high concordance across all analytes and clarity parameters.

Technological Characteristics

The system uses reflectance photometry for chemical analysis and a physical measurement cell (PMC) for clarity/specific gravity. It is a fully automated, rack-based system. Test strips are provided in RFID-tagged cassettes. Connectivity includes data transmission to laboratory systems. Electrical safety complies with IEC 61010-1. Software is used for automated processing, color correction, and result calculation.

Indications for Use

Indicated for trained operators in clinical laboratories for the qualitative or semi-quantitative determination of urine analytes (pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color, erythrocytes, and clarity) to evaluate renal, urinary, hepatic, and metabolic disorders. Prescription use only. Test strips are not for visual reading.

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

• cobas u 411 (K093555)
• Urisys 2400 (K012397)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is an emblem of the Department of Health and Human Services, which features a stylized caduceus with a triple helix. To the right of the emblem, there is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in bold, blue letters, and below that, the word "ADMINISTRATION" in smaller, blue letters.

May 7, 2019

Roche Diagnostics Angela Clements Regulatory Affairs Principal 9115 Hague Road Indianapolis, IN 46250

Re: K183432

Trade/Device Name: cobas u 601 urinalysis test system Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: Class II Product Code: JIL, JIO, CDM, CEN, JIN, JIR, JJB, JMT, LJX, KQO Dated: March 22, 2019 Received: March 25, 2019

Dear Angela Clements:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) k183432

Device Name cobas u 601 urinalysis test system

### Indications for Use (Describe)

The cobas u 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack.

The cobas u 601 urine analyzer when used with the cobas u pack is a fully automated urinalysis system intended for the in vitro qualitative or semi- quantitative determination of urine analytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color and erythrocytes, as well as clarity. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders. This system is intended to be used by trained operators in clinical laboratories.

The cobas u pack is a cassette loaded with cobas u 601 test strips for the in vitro qualitative or semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color and erythrocytes in urine with the cobas u 601 urine analyzer. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders.

Type of Use (Select one or both, as applicable)

| <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|-----------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# cobas u 601 Urinalysis Test System 510(k) Summary k183432

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification 510(k).

The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for the cobas u 601 Urinalysis Test System.

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| Submitter Name | Roche Diagnostics |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 9115 Hague Road<br>P.O. Box 50416<br>Indianapolis, IN 46250-0457 |
| Contact | Angie Clements<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail]<br><br>Michael Leuther<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| Date Prepared | December 10, 2018 |
| Proprietary Name | cobas u 601 Urinalysis Test System |
| Common Name | Automated urinalysis system<br>Reagent strip for urinalysis |
| Product Codes,<br>Regulation Numbers | See Table 1 |
| Predicate Devices | cobas u 411 (k093555) |
| Establishment Registration | For the cobas u 601 Urinalysis Test System the establishment registration<br>number for Roche Diagnostics GmbH in Mannheim, Germany is 9610126. The<br>establishment registration number for Roche Diagnostics in the United States is<br>1823260. |

### Table 1: Product Codes and Regulation Numbers

| Device/Analyte | Product Code | Classification | Regulation | Panel |
|--------------------------------------------|--------------|----------------|-----------------|---------------|
| Automated urinalysis<br>system | KQO | Class I | 21 CFR 862.2900 | 75 Chemistry |
| Glucose, urinary, non-<br>quantitative | JIL | Class II | 21 CFR 862.1340 | 75 Chemistry |
| Blood, occult,<br>colorimetric, in urine | JIO | Class II | 21 CFR 864.6550 | 81 Hematology |
| Urobilinogen, urinary,<br>non-quantitative | CDM | Class I | 21 CFR 862.1785 | 75 Chemistry |

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| Device/Analyte | Product Code | Classification | Regulation | Panel |
|---------------------------------------------------------------|--------------|----------------|-----------------|---------------|
| pH, urinary, non-<br>quantitative | CEN | Class I | 21 CFR 862.1550 | 75 Chemistry |
| Ketones, non-<br>quantitative | JIN | Class I | 21 CFR 862.1435 | 75 Chemistry |
| Protein or albumin,<br>urinary, non-<br>quantitative | JIR | Class I | 21 CFR 862.1645 | 75 Chemistry |
| Nitrite, non-<br>quantitative | JMT | Class I | 21 CFR 862.1510 | 75 Chemistry |
| Leukocyte, peroxidase<br>test | LJX | Class I | 21 CFR 864.7675 | 81 Hematology |
| Bilirubin and its<br>conjugates, urinary,<br>non-quantitative | JJB | Class I | 21 CFR 862.1115 | 75 Chemistry |
| Color | | | No regulation | |
| Clarity | | | No regulation | |

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#### DEVICE DESCRIPTION 1.

The cobas u 601 Urinalysis Test System consists of the following components:

- . cobas u 601 urine analyzer
- . cobas u pack

#### 1.1. cobas u 601 urine analyzer

The cobas u 601 urine analyzer is a fully automated urine analysis system. It is optimized for high throughput workloads in the professional environment. The cobas u 601 urine analyzer performs a maximum theoretical throughput of up to 240 samples per hour.

The cobas u 601 analyzer consists of several major components:

- Rack transport system
- Liquid handling system
- Test strip cassette compartment
- Automated test strip processing area
- Photometer which is a 4 wavelength reflectance measuring unit based on a Complementary Metal Oxide Semiconductor chip used in digital cameras (CMOS sensor)
- Physical Measurement Cell (PMC): flow cell connected to an optical detector ●
- Touch Screen
- Inbuilt Computer

The functions of the cobas u 601 urine analyzer include:

- Sample loading and transport ●
- . Sample identification
- Robotic pipetting of samples onto test pads on test strips

51(k) Premarket Notification Print Date: May 6, 2019

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- Robotic aspiration of samples into the PMC
- . Controlled incubation
- . Photometric measurement of test strips
- Optical determination in the PMC
- Automatic disposal of used test strips ●
- . Result readout
- Result memory
- Optional formats for data output including electronic result communication

The operating system will be a Microsoft Windows for embedded devices. The system will use a Postgres/SQL database.

The cobas u 601 urine analyzer is designed to be inter-connected mechanically and electronically with another urine sediment analyzer (cobas u 701) in order to create a urine work area (cobas® 6500).

#### 1.2. cobas u pack

The cobas u pack is a cassette containing 400 tests strips. The cobas u 601 analyzer will use the cobas u pack to dispense single test strips for each sample.

Each test strip has ten individual test pads that are used to test for different substances or characteristics. The test strips are analyzed automatically through the analyzer. One test strip is used per sample. When a strip is dispensed for use by the cobas u 601, an aliquot of the urine sample is pipetted onto each of the test pads. The resulting color changes are measured photometrically.

The test strip in the cobas u pack cassette ("cassette test strip") is a multi-parameter urine analysis test strip, with test pads for blood (Erythrocytes), Leukocytes, Nitrite, Proteins, Glucose, Ketones, Bilirubin, Urobilinogen, Color and pH.

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The cobas u pack is technically identical to the marketed Urisys 2400 Cassette with 400 test strips (cleared under K012397) with the following modifications:

- Added RFID-tag (ISO15693; 13.56 MHz)
- own labeling and own Id. No.
- . different brand

The RFID-tag is used for storing test strip related information to improve the safety and the convenience of the system. The following data is stored on the RFID-Tag:

- . generic product data
- strip cassette data
- test strip related data
- . cassette number
- lot number
- expiry date
- load date
- check sum

The on-board time is checked by the instrument and an alarm is triggered if the on-board time of a strip cassette (identified through its RFID-tag) exceeds its specified on-board stability.

### 2. INDICATIONS FOR USE

The cobas u 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack. The cobas u 601 urine analyzer when used with the cobas u pack is a fully automated urinalysis system intended for the in vitro qualitative or semiquantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color and erythrocytes, as well as clarity. These

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measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders. This system is intended to be used by trained operators in clinical laboratories.

The cobas u pack is a cassette loaded with cobas u 601 test strips for the in vitro qualitative or semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color and erythrocytes in urine with the cobas u 601 urine analyzer. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders.

### TECHNOLOGICAL CHARACTERISTICS 3.

The following tables compare the cobas u 601 Urinalysis Test System with its predicate device, cobas u 411 (k093555).

| Feature | cobas u 411 (Predicate Device) | cobas u 601 Urinalysis Test<br>System (proposed device) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The cobas u 411 urine analyzer is a semi-<br>automated, benchtop analyzer which is designed<br>to read the Chemstrip 10 UA (Combur10 Test M)<br>test strips for urinalysis for the measurement of<br>bilirubin,<br>blood,<br>glucose,<br>ketone,<br>leukocytes,<br>nitrite,<br>pH,<br>protein,<br>specific gravity,<br>urobilinogen and<br>color (if selected).<br>These measurements are useful in the evaluation<br>of renal, urinary and metabolic disorders. Tests | The cobas u 601 urine analyzer<br>when used with the cobas u pack<br>is a fully automated urinalysis<br>system intended for the in vitro<br>qualitative or semi-quantitative<br>determination of urine analytes,<br>including<br>pH,<br>leukocytes,<br>nitrite,<br>protein,<br>glucose,<br>ketones,<br>urobilinogen,<br>bilirubin, color and erythrocytes,<br>as well as clarity.<br>These measurements are useful<br>in the evaluation of renal, urinary<br>and metabolic disorders. This |
| | performed using the cobas u 411 are intended for<br>prescription, in vitro diagnostic use only. | system is intended to be used by<br>trained operators in professional<br>laboratories. |
| Submission | K093555 | N/A |
| Feature | cobas u 411 (Predicate Device) | cobas u 601 Urinalysis Test<br>System (proposed device) |
| Automation | Semi-Automated | Fully Automated |
| Specimen | Urine | same |
| Analyzer Technology | Reflectance photometry | Reflectance photometry for<br>• pH,<br>• Leukocytes,<br>• Nitrite,<br>• Protein,<br>• Glucose,<br>• Ketones,<br>• Urobilinogen,<br>• Bilirubin, and<br>• Erythrocytes (blood). |
| Reagent Strip Format | Chemstrip 10 UA test strip | cobas u pack loaded with cobas<br>u 601 test strips |
| | Width: 5.0 mm | Width: 4.2 mm |
| | Length: 121 mm (with handle area) | Length: 104.9 mm (no handle<br>area) |
| | Number of pads: 11 | Number of pads: 10 (without<br>specific gravity)<br>Same distance between pads |
| | Sequence of pads:<br>1. specific gravity,<br>2. pH,<br>3. leukocytes,<br>4. nitrite,<br>5. protein,<br>6. glucose,<br>7. ketone,<br>8. urobilinogen,<br>9. bilirubin,<br>10. blood,<br>11. color<br>pH pad: no underlying paper | Sequence of pads:<br>1. Blood,<br>2. leukocytes,<br>3. nitrite,<br>4. ketone,<br>5. glucose,<br>6. protein,<br>7. urobilinogen,<br>8. bilirubin,<br>9. color,<br>10. pH<br>(no specific gravity)<br>pH pad: underlying paper<br>(different height) |
| | leukocytes: 1x underlying paper | Leukocytes: no underlying paper<br>(different height) |
| Feature | cobas u 411 (Predicate Device) | cobas u 601 Urinalysis Test<br>System (proposed device) |
| | nitrite: 1x underlying paper | nitrite: no underlying paper<br>(different height) |
| | protein: 2 x protein layer | protein: 1 x protein layer<br>(different color density) |
| | Glucose | Same format |
| | Ketone | Same format |
| | Urobilinogen | Same format |
| | Bilirubin | Same format |
| | Blood | Same format |
| | Color | Same format |
| Strip Delivery | Measurement of single strips, insert manually into<br>the instrument out of a vial | Automated test strip delivery<br>from cassette |
| Test Principles | pH: color change with the indicators methyl red,<br>phenolphthalein and bromothymol blue. | Same |
| | Leukocytes: esterases cleave an indoxyl ester,<br>and the indoxyl reacts with a diazonium salt to<br>produce a purple color.<br>Nitrite: based on the principle of the Griess test.<br>Nitrite, if present, reacts with an aromatic amine to<br>give a diazonium salt, which yields a red-violet azo<br>dye. | Same |
| | Protein: based on the "protein error of pH<br>indicators" involving<br>tetrachlorophenoltetrabromosulfophthalein | Same |
| | Glucose: based on the specific glucose<br>oxidase/peroxidase reaction (GOD/POD<br>method). | Same |
| | Ketone: based on the principle of Legal's<br>test involving use of sodium nitroprusside. | Same |
| | Urobilinogen: Urobilinogen is coupled<br>with 4-methoxybenzene-diazonium-<br>tetrafluoroborate in an acid medium to<br>form a red azo dye. | Same |
| Feature | cobas u 411 (Predicate Device) | cobas u 601 Urinalysis Test<br>System (proposed device) |
| | Bilirubin: based on the, coupling of<br>bilirubin with a diazonium salt. | Same |
| | Blood: The peroxidase-like action of hgb and<br>myoglobin catalyzes the oxidation of the indicator<br>by the organic peroxide. | Same |
| Light sources | LEDs | LEDs |
| Wavelengths | Light Emitting Diodes (LEDs)<br>Wavelength:<br>Orange: 620 nm<br>Green: 555 nm<br>Blue: 470 nm | Light Emitting Diodes (LEDs)<br>Wavelength:<br>Red: 615 nm<br>Green: 560 nm<br>True Green: 525 nm<br>Blue: 465 nm |
| Remission Sensor | 11 wide range photo sensors | Camera with CMOS<br>(Complementary Metal Oxide<br>Semiconductor) sensor |
| Sample Preparation | 1. Remove the test strip from the vial and close the<br>vial<br>2. Dip all test pads of the test strip completely in<br>the sample and wipe off excessive urine on the<br>edge of the sample tube.<br>3. Position the test strip on the test strip tray for<br>analysis | 1. Preparation of sample racks<br>and tubes<br>2. Loading the rack(s) onto the<br>analyzer<br>3. Start (automatic) analysis of<br>samples |
| Sample application | Manually dip of the strip | Robotic pipetting of samples onto<br>test pads on test strips |
| Calibration method | Calibration strips with specific reflectance values<br>for calibration. | Same |
| Intrinsic color compensation | Area not impregnated with reagents, allows<br>instrumental compensation for the intrinsic color of<br>the urine while testing | Same |
| Feature | cobas u 411 (Predicate Device) | cobas u 601 Urinalysis Test<br>System (proposed device) |
| Output values | The operator can view the<br>concentration ranges for each test parameter. | |
| | Units:<br>conventional,<br>SI,<br>Arbitrary,<br>SI & Arbitrary<br>Conventional & Arbitrary | Same |
| | ERY neg / 10 / 25 / 50 / 150 / 250 p/μl | Same |
| | LEU neg / 25 / 100 / 500 p/µl | Same |
| | NIT neg / pos | Same |
| | PRO neg / 15 / 30 / 100 / 500 mg/dl | Same |
| | GLU norm / 50 / 100 / 250 / 1000 mg/dl | Same |
| | KET neg / 5 / 15 / 50 / 150 mg/dl | Same |
| | BIL neg / 1 / 3 / 6 mg/dl | Same |
| | pH 5 / 6 / 6.5 / 7 / 8 / 9 | Same |
| | UBG norm / 1 / 4 / 8 / 12 mg/dl | Same |
| Strip Detector | Two strip detectors | Automatic strip transportation<br>system |
| Strip packaging | In vials of 100 strips | In cassette of 400 strips |
| Feature | cobas u 411 (Predicate Device) | cobas u 601 Urinalysis Test<br>System (proposed device) |
| Strip storage | Store at 20°C - 30°C.<br>Close vial immediately after use. | Store at 20°C - 30°C.<br>After loading the cassette into<br>the analyzer, the test strips are<br>stable within the tightly closed<br>cassette compartment for 14<br>days.<br>After this period, the cassette<br>has to be replaced by a new one. |
| Operating Conditions | Temperature:<br>operational: 15 - 32 °C<br>storage: -25 - 60 °C<br>Humidity:<br>operational: 30 - 80%<br>storage: 10 - 95% | Temperature:<br>operational: 15 - 32 °C<br>storage: 5 - 40 °C<br>Humidity:<br>operational: 30 - 80%<br>storage: 10 - 85% |
| Storage Medium | USB stick | USB stick |
| Sample identification | Sample identification with optional external<br>barcode scanner | Internal barcode reader for rack<br>ID and sample ID recognition |
| Printer | Integrated thermal paper | Optional external printer |
| Controlled incubation | Controlled incubation period after placing the wet<br>strip on the test strip tray | Controlled incubation period after<br>sample pipetting onto test pads<br>on test strips |
| Result Memory | Memory for 1000 entries (pending samples and<br>results) | Result memory is available |

# Table 2: Similarities and Differences between the cobas u 601 Urinalysis Test System and the cobas u411 System

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### NON-CLINICAL PERFORMANCE EVALUATION 4.

#### 4.1. Linearity/Reportable Results

The reportable results are determined by the analytical sensitivity and method comparison studies (Sections 4.2 and 5.1.3).

The results of those studies support the following reportable results:

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| Parameter | Unit of Measure | Reportable Results |
|-----------|------------------|------------------------------------------------------------------|
| NIT | NA | Neg/Pos |
| GLU | mg/dL | Norm to 1000 |
| KET | mg/dL | Neg to 150 |
| BIL | mg/dL | Neg to 6 |
| UBG | mg/dL…