(136 days)
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.
The cobas u 411 urine analyzer is a semi-automated, benchtop analyzer which is designed to read Chemstrip 10 UA (Combur10 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. 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
The provided text is a 510(k) Summary for the cobas u 411 Urinalysis Test System. While it describes the device's intended use, its components, and compares it to a predicate device, it does not contain information about acceptance criteria, specific study designs, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance data.
The document states that the cobas u 411 urinalysis test system is "substantially equivalent to other devices legally marketed in the United States" and claims equivalence to the Chemstrip Urine Analyzer (K921087 and K931602). This implies that the device likely met performance criteria comparable to the predicate device, but the details of those criteria and the specific study proving their achievement are not included in this summary.
Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, and expert involvement as the information is not present in the provided text.
The text focuses on classifying the device, describing its technology, and comparing its features to an existing, legally marketed device to establish substantial equivalence. It does not delve into the detailed clinical or analytical performance study results that typically include acceptance criteria and their verification.
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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 Corporation9115 Hague RoadIndianapolis, IN 46250(317) 521-4569Contact Person: Jennifer TribbettDate Prepared: March 24, 2010 |
| Device Name | Proprietary name: (1) Chemstrip 10 UA(2) cobas u 411 Urine AnalyzerCommon name: (1) Reagent Strip for urinalysis(2) Automated Urinalysis SystemClassification name: (1) Urinary glucose, ketones, nitrite, protein, blood, bilirubin, urobilinogen, leukocytes, pH and specific gravity(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(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 | ClassificationNumber | Panel Name | Exempt | DeviceClass | RegulationCitation |
|---|---|---|---|---|---|
| Diazonium Colorimetry,urobilinogen (urinary, non-quant) | CDM | 75 ClinicalChemistry | YES | I | 21 CFR862.1785 |
| Dye-Indicator, pH (Urinary, non-quant) | CEN | 75 ClinicalChemistry | YES | I | 21 CFR862.1550 |
| Nitroprusside, ketones (urinary, non-quant) | JIN | 75 ClinicalChemistry | YES | I | 21 CFR862.1435 |
| Indicator method, protein or albumin(urinary, non-quant) | JIR | 75 ClinicalChemistry | YES | I | 21 CFR862.1645 |
| Diazo (colormetric), Nitrite(Urinary, non-quant) | JMT | 75 ClinicalChemistry | YES | I | 21 CFR862.1510 |
| Test, Urine Leukocyte | LJX | 82Hematology | YES | I | 21 CFR864.7675 |
| Azo-dyes, colormetric, bilirubin &its con | JJB | 75 ClinicalChemistry | YES | I | 21 CFR862.1115 |
| Automated Urinalysis System | KQO | 75 ClinicalChemistry | YES | I | 21 CFR862.2900 |
| Refractometer for clinical use | JRE | 75 ClinicalChemistry | YES | I | 21 CFR862.2800 |
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(predicate) | cobas u 411 urinalysis test system(proposed) |
|---|---|---|
| Intended Use | The Chemstrip Urine Analyzer is asemiautomated, computerized analyzerintended for the in vitro semi-quantitative determination of urineanalytes, including specific gravity(SG), pH, leukocytes, nitrite, protein,glucose, ketones, urobilinogen,bilirubin and erythrocytesNote: A compensation pad is providedto aid in the correction of interferencefrom the intrinsic color of urine. | The cobas u 411 urine analyzer is asemi-automated, benchtop analyzerwhich is designed to read Chemstrip 10UA (Combur10 Test M) test strips forurinalysis for the measurement ofbilirubin, blood, glucose, ketone,leukocytes, nitrite, pH, protein, specificgravity, urobilinogen and color (ifselected). These measurements areuseful in the evaluation of renal,urinary and metabolic disorders. Testsperformed using the cobas u411 areintended for prescription, in vitrodiagnostic use only. |
| AnalyzerTechnology | Reflectance photometry | Same |
| Light Source | LEDs | Same |
| Reagent Strip | Chemstrip 10 UA test strip | Same |
| Urineapplication | Test strip dipped into urine sample | Same |
| Intrinsic colorcompensation | The test strip area not impregnatedwith reagents, allows instrumentalcompensation for the intrinsic color ofthe urine while testing. | Same |
| Calibrationmethod | Calibration strips with specificreflectance values for calibration. | Same |
| Feature | Chemstrip Urine Analyzer(predicate) | cobas u 411 urinalysis test system(proposed) |
| Test Principle | pH: color change with the indicatorsmethyl red and bromthymol blue.Leukocytes: esterase cleaves an indoxylester, and the indoxyl reacts with adiazonium salt to produce a purple color.Nitrite: based on the principle of theGriess test. Nitrite, if present, reacts withan aromatic amine to give a diazonium saltwhich yields a red-violet azo dye.Protein: based on the "protein error of pHindicators" involving tetrachlorophenol-tetrabromosulfophthaleinGlucose: based on the specific glucoseoxidase/peroxidase reaction (GOD/PODmethod).Ketone: based on the principle of Legal'stest involving use of sodium nitroprusside.Urobilinogen: Urobilinogen is coupledwith 4-methoxybenzene-diazonium-tetrafluoroborate in an acid medium toform a red azo dye.Bilirubin: based on the coupling ofbilirubin with a diazonium salt.Blood: The peroxidase-like action of hgband myoglobin catalyzes the oxidation ofthe indicator by the organic peroxide.Specific Gravity: In the presence ofcations, protons are released by acomplexing agent in the test and produce acolor change | Same |
| Feature | Chemstrip Urine Analyzer (predicate) | cobas u 411 urinalysis test system (proposed) |
| Measuring Unit | Light Emitting Diodes (LEDs)Wavelength:Orange: 620 nmGreen: 555 nmRed: 660 nmReader Head: 2 heads with 3 LEDs each | Light Emitting Diodes (LEDs)Wavelength:Orange: 620 nmGreen: 555 nmBlue: 470 nmSensor: 11 wide range photo sensors |
| Operating Conditions | Temperature:•operational: 15 - 34 °C•storage: -20 - 60 °CHumidity:•operational: 20 - 80%•storage: 20 - 95% | Temperature:•operational: 15 - 32 °C•storage: -25 - 60 °CHumidity:•operational: 30 - 80%•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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 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
Page 1 of 1
§ 862.2900 Automated urinalysis system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.