COBAS U411 TEST SYSTEM
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 |
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.
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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k093555
B. Purpose for Submission:
New submission to add the Cobas u 411 Urine Analyzer for use with the Chemstrip 10 UA test strip k896454.
C. Measurand:
Urine pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin, blood, specific gravity and optional urine color
D. Type of Test:
Qualitative and semi-quantitative measurements based on reflectance photometry
E. Applicant:
Roche Diagnostics Corporation
F. Proprietary and Established Names:
Cobas u 411 Test System
G. Regulatory Information:
| Classification Name | Product Code | Device Class | Regulation Number |
| --- | --- | --- | --- |
| Urinary glucose (non-quantitative) test system | JIL | II | 21 CFR§862.1340 |
| Occult blood test | JIO | II | 21 CFR§864.6550 |
| Urinary urobilinogen (non-quantitative) test system | CDM | I | 21 CFR§862.1785 |
| Urinary bilirubin and its conjugates (non-quantitative) test system | JJB | I | 21 CFR§862.1115 |
| Ketones (non-quantitative test system) | JIN | I | 21 CFR§862.1435 |
| Urinary protein or albumin (non-quantitative) test system | JIR | I | 21 CFR§862.1645 |
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| Nitrite (non-quantitative) test system | JMT | I | 21 CFR§862.1510 |
| --- | --- | --- | --- |
| Leukocyte peroxidase test | LJX | I | 21 CFR§864.7675 |
| Urinary pH (non-quantitative) test system | CEN | I | 21 CFR§862.1550 |
| Specific Gravity | JRE | I | 21 CFR§862.2800 |
| Automated Urinalysis System | KQO | I | 21 CFR§862.2900 |
Panel:
(75) Clinical Chemistry and (81) Hematology
H. Intended Use:
1. Intended use(s):
See indications for use below.
2. Indication(s) for use:
The cobas u 411 urinalysis analyzer is a semi-automated, bench top analyzer which is designed to read Chemstrip 10 UA (Combur¹⁰ Test M) test strips for urinalysis for the measurement of bilirubin, blood, glucose, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen and color (if selected). These measurements are useful in the evaluation of renal, urinary and metabolic disorders. 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.
3. Special conditions for use statement(s):
Prescription use only
4. Special instrument requirements:
Cobas u 411 urine analyzer
I. Device Description:
The cobas u 411 is a semiautomatic urinalysis system intended for in vitro qualitative or semi-quantitative determination of urine analytes, including specific gravity, (SG), pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, erythrocytes, and color (if selected) using the Chemstrip 10 UA test strips (k896454).
The functions of the cobas u 411 analyzer include:
- Sample identification (with optional barcode scanner)
- Controlled incubation period
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- Photometric measurements
Result memory
- Optional formats for data output
# J. Substantial Equivalence Information:
1. Predicate device name(s): Roche Chemstrip Urine Analyzer
2. Predicate 510(k) number(s): k921087
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Cobas u411 urinalysis test system (candidate device) | Chemstrip Urine Analyzer (predicate device) k921087 |
| Intended use/Indications for use | A semi-automated analyzer which is designed to read test strips for urinalysis for the measurement of bilirubin, blood, glucose, ketones, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. The device is for prescription in vitro diagnostic use only. | Same |
| Analyzer Technology | Reflectance Photometry | Same |
| Light Source | LEDs | Same |
| Reagent Strip | Chemstrip 10 UA test strip | Same |
| Urine application | Test strip dipped into urine sample | Same |
| Intrinsic color compensation | The test strip area not impregnated with reagents, allows instrumental compensation for the intrinsic color of the urine while testing. | Same |
| Calibration method | Calibration strips with specific reflectance values for calibration | Same |
| Differences | | |
| --- | --- | --- |
| Item | Cobas u 411 urinalysis test system (candidate device) | Chemstrip Urine Analyzer (predicate device) k921087 |
| Measuring Unit | Light Emitting Diodes (LEDs) Wavelength: Orange: 620 nm Green: 555 nm Blue: 470 nm Sensor: 11 wide range photo sensors | Light Emitting Diodes (LEDs) Wavelength: Orange: 620 nm Green: 555 nm Red: 660 nm Reader Head: 2 heads with 3 LEDs each |
| Storage Medium | USB Stick | Floppy Disks |
| Strip Detector | Two strip detectors | One strip detector |
| Urine color parameter | Optional Urine color parameter | None |
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K. Standard/Guidance Document Referenced (if applicable):
EN ISO 14971 Medical devices-Application of risk management to medical devices (ISO14971:2007)
L. Test Principle:
Several light emitting diodes (LEDs) use a light pipe to transmit light of a defined wavelength onto the surface of all test pads. The light that hits the test pad is reflected with an intensity that is dependent upon the color of the test pads. A photodiode detector positioned directly above the test pad receives the reflected light. The photodiode detector transmits an analog electrical signal to the analog-to digital convertor, which changes the analog signal to a digital value. The computer then converts the digital value into the semiquantitative result.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Repeatability (within run) precision of the cobas u 411 analyzer was evaluated at 3 clinical sites using two commercially available urine controls over various days. The controls, which were comprised of a normal and an elevated analyte sample, were tested in three individual runs. Each run was comprised of 21 replicates. The samples were split into seven aliquots with 3 measurements. In total, there were 48 runs performed and three analyzers were used in the testing.
Example: 3 runs x 21 replicates (7 aliquots/3 measurements per aliquot) x 3 analyzers= 189 replicates.
Commercial Urinalysis Control, Level 1 values confirmed with Cobas u 411
| Analyte | Mean | Unit | Results = Mean (%) | Results of ± 1 block of Mean (%) | n |
| --- | --- | --- | --- | --- | --- |
| Specific Gravity | 1.015 | - | 98 | 99 | 189 |
| pH | 6.0 | - | 94 | 100 | 189 |
| Leukocyte Esterase | Negative | Leu/μL | 100 | 100 | 189 |
| Nitrite | Negative | - | 100 | 100 | 189 |
| Protein | Negative | mg/dL | 100 | 100 | 189 |
| Glucose | Normal | mg/dL | 100 | 100 | 189 |
| Ketone | Negative | mg/dL | 100 | 100 | 189 |
| Urobilinogen | Normal | mg/dL | 100 | 100 | 189 |
| Bilirubin | Negative | mg/dL | 100 | 100 | 189 |
| Blood | Negative | Ery/μL | 100 | 100 | 189 |
| Color | Pale Yellow | - | 97 | 100 | 189 |
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Commercial Urinalysis Control, Level 2 values confirmed with Cobas u 411
| Analyte | Mean | Unit | Results = Mean (%) | Results of ± 1 block of Mean (%) | n |
| --- | --- | --- | --- | --- | --- |
| Specific Gravity | 1.010 | - | 67 | 99 | 189 |
| pH | 7.0 | - | 100 | 100 | 189 |
| Leukocyte Esterase | 500 | Leu/μl | 100 | 100 | 189 |
| Nitrite | Positive | - | 100 | 100 | 189 |
| Protein | 150 | mg/dl | 97 | 100 | 189 |
| Glucose | 1000 | mg/dl | 99 | 100 | 189 |
| Ketone | 150 | mg/dl | 100 | 100 | 189 |
| Urobilinogen | 12 | mg/dl | 100 | 100 | 189 |
| Bilirubin | 6 | mg/dl | 100 | 100 | 189 |
| Blood | 250 | Ery/μl | 100 | 100 | 189 |
| Color | Brown | - | 100 | 100 | 189 |
Precision was determined using two levels of commercially available control material. Day to day precision was evaluated by testing several replicates of each control level per three instruments over multiple days.
Level 1 Normal
| Analyte | Mean | Unit | Results = Mean (%) | Results of ± 1 block of Mean (%) | n |
| --- | --- | --- | --- | --- | --- |
| Specific Gravity | 1.015 | - | 100 | 100 | 99 |
| pH | 6.0 | - | 99 | 100 | 99 |
| Leukocyte Esterase | Negative | Leu/μl | 100 | 100 | 99 |
| Nitrite | Negative | - | 100 | 100 | 99 |
| Protein | Negative | mg/dl | 100 | 100 | 99 |
| Glucose | Normal | mg/dl | 100 | 100 | 99 |
| Ketone | Negative | mg/dl | 100 | 100 | 99 |
| Urobilinogen | Normal | mg/dl | 100 | 100 | 99 |
| Bilirubin | Negative | mg/dl | 100 | 100 | 99 |
| Blood | Negative | Ery/μl | 100 | 100 | 99 |
| Color | Pale Yellow | - | 89 | 100 | 99 |
Level 2 Abnormal
| Analyte | Mean | Unit | Results = Mean (%) | Results of ± 1 block of Mean (%) | n |
| --- | --- | --- | --- | --- | --- |
| Specific Gravity | 1.005 | - | 55 | 100 | 99 |
| pH | 7.0 | - | 100 | 100 | 99 |
| Leukocyte Esterase | 500 | Leu/μl | 100 | 100 | 99 |
| Nitrite | Positive | - | 100 | 100 | 99 |
| Protein | 150 | mg/dl | 94 | 100 | 99 |
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| Glucose | 1000 | mg/dl | 100 | 100 | 99 |
| --- | --- | --- | --- | --- | --- |
| Ketone | 150 | mg/dl | 100 | 100 | 99 |
| Urobilinogen | 12 | mg/dl | 100 | 100 | 99 |
| Bilirubin | 6 | mg/dl | 100 | 100 | 99 |
| Blood | 250 | Ery/μl | 100 | 100 | 99 |
| Color | Brown | - | 100 | 100 | 99 |
b. Linearity/assay reportable range:
Please see the method comparison section 2.a below and detection limit section 1.d. below.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The sponsor recommends using commercially available control materials for use on the cobas u 411 urine analyzer.
Calibration verification is performed using a Calibration Strip which is included with the analyzer. This is a gray strip which checks the reflectance values for each test. The reflectance values are compared with the previous user calibration values and the values of the internal Calibration Strip. Recommendations for calibration verification are included in the operator's manual.
d. Detection limit:
The sensitivity of the Chemstrip 10UA Urine Test Strip on the cobas u411 was evaluated by spiking negative pooled human urine with the appropriate substance to obtain the desired concentrations. Multiple samples were tested for each concentration. The prepared samples were then assayed on the cobas u 411 analyzer. Sensitivity was defined as the cutoff in which 90% of the contrived pooled measurements were positive.
| Parameter | Claim (Package Insert Chemstrip UA) | Point at which sensitivity meets criteria of >90% detection |
| --- | --- | --- |
| Erythrocytes | 5 - 10 Ery/μl | 7 E/μl |
| Leukocytes | 20- 25 Leu/μl | 23 L/μl |
| Protein | 8 - 12 mg/dL | 8 mg/dl |
| Glucose | 30 - 40 mg/dl | 40 mg/dl |
| Ketones | 3 - 6 mg/ dl | 4 mg/dl |
| Nitrite | 0.05 - 0.07 mg/dl | 0.06 mg/dl |
| Bilirubin | 0.4 - 0.6 mg/dl | 0.6 mg/dl |
| Urobilinogen | 1.0 - 1.6 mg/dl | 1.2 mg/dl |
e. Analytical specificity
A urine pool was prepared using fresh normal/negative urine and urine samples with parameters in the first positive range. Solutions were also prepared using high drug concentrations and prepared with the maximum daily dosage of the medical relevant
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drug concentration. Multiple replicates of the urine pool and the drug solutions were measured.
Interfering substances and their effects on the various analytes:
| Test | Interfering substances | Impact on Test |
| --- | --- | --- |
| Leukocytes | n-Acetyl Cysteine ≥ 1 mg/l, Cefoxitin ≥ 1000 mg/l, Curcumin ≥ 3500 mg/l, Levodopa ≥ 250 mg/l, p-Aminosalicylic Acid ≥ 12740 and Tetracycline ≥ 100 mg/l | False positive |
| | Gentamicin Sulfate ≥ 80 mg/l, Imipenem ≥ 3000 mg/l, Meropenem ≥ 4000 mg/l, Formaldehyde ≥ 2000 mg/l | False positive |
| | Captopril ≥ 100 mg/l | False negative |
| | Elevated glucose >5 g/dL | False negative |
| | High pH values caused by urinary tract infections and a low specific gravity | False positive |
| Nitrite | 2-mercaptoethanesulphonate sodium (MESNA) ≥ 11400 mg/l | False negative |
| Protein | Acetaminophen ≥ 500 mg/l, Chloroquine ≥ 380 mg/l, Levodopa ≥ 250 mg/l, Nitrofurantoin ≥ 200 mg/l | False positive |
| --- | --- | --- |
| Glucose | Ascorbic Acid ≥75mg/dL | False negative |
| | Nitrofurantoin ≥ 200 mg/l | False negative |
| | MESNA ≥ 11400 mg/l | False positive |
| | Oxidizing cleaning agents ≥ 110 mg/l, Mecetronium Etilsulfate ≥ 40 mg/l | False positive |
| Ketones | Captopril ≥ 100 mg/l, Curcumin ≥ 3500 mg/l, Imipenem ≥ 3000 mg/l, MESNA ≥ 11400 mg/l or other sulfhydryl containing compounds. | False positive |
| | Formaldehyde ≥ 2000 mg/l | False positive |
| Bilirubin | Ascorbic Acid >40 mg/dL | False negative |
| | Imipenem ≥ 3000 mg/l, Penicillin ≥ 8150 mg/l, p-Aminosalicylic Acid ≥ 12740 mg/l, Hydrochloric Acid ≥ 6660 mg/l | False positive |
| | MESNA ≥ 11400 mg/l | False negative |
| | Urobilinogen ≥ 120 mg/l | False positive |
| | pH >9.0 | False positive |
| Urobilinogen | p-Aminosalicylic Acid ≥ 12740 mg/l, Sulfamethoxazol ≥ 1070 mg/l | False positive |
| | Formalin concentrations >200 mg/dL | False negative |
| | Nitrite concentrations >0.6 mg/dL | False negative |
| | pH >9.0 | False positive |
| Blood | Ascorbic Acid >75 mg/dL | False negative |
| | Phenazopyridine ≥ 50 mg/l | False positive |
| | Nitrofurantoin ≥ 200 mg/l, Quinidine ≥ 320 mg/l | False negative |
| | MESNA ≥ 11400 mg/l | False positive and false negative |
| | Leukocytes ≥ 500 LEU/μl | False positive |
| | pH >9.0 | False positive |
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f. Assay cut-off:
Not applicable
2. Comparison studies:
a. Method comparison with predicate device:
Both fresh and spiked samples were used to cover the entire analytical range. Each sample was split into two aliquots.
The clinical study was performed at three different clinical sites. At least two intended users operated the device at each site.
Cobas u411 urinalysis test system with Chemstrip 10 UA Test strip vs. Chemstrip Urine analyzer with Chemstrip 10 UA Test strip:
| | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Erythrocytes (Blood) | 0 Neg | 10 | 25 | 50 | 150 | 250 |
| Candidate Device | | | | | | |
| 0 Neg | 207 | 6 | | | | |
| 10 | 13 | 99 | 2 | | | |
| 25 | | 5 | 93 | 4 | | |
| 50 | | | 8 | 71 | 6 | |
| 150 | | | | 3 | 83 | 11 |
| 250 | | | | | 1 | 101 |
| Total | 220 | 110 | 103 | 78 | 90 | 112 |
| %Agreement (Exactly match) | 94 | 90 | 90 | 91 | 92 | 90 |
| %Agreement (+/- 1 Color Block) | 100 | 100 | 100 | 100 | 100 | 100 |
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| | Predicate Device | | | |
| --- | --- | --- | --- | --- |
| Leukocytes | Neg | 25 | 100 | 500 |
| Candidate Device | | | | |
| Neg | 187 | 4 | | |
| 25 | 5 | 101 | 3 | |
| 100 | | 2 | 69 | 3 |
| 500 | | | 2 | 93 |
| Total | 192 | 107 | 74 | 96 |
| %Agreement (Exactly match) | 97 | 94 | 93 | 97 |
| %Agreement (+/- 1 Color Block) | 100 | 100 | 100 | 100 |
| | Predicate Device | |
| --- | --- | --- |
| Nitrite | Negative | Positive |
| Candidate Device | | |
| Negative | 104 | 2 |
| Positive | 4 | 80 |
| Total | 108 | 82 |
| %Agreement (Exactly match) | 96 | 98 |
| %Agreement (+/- 1 Color Block) | 100 | 100 |
| | Predicate Device | | | | |
| --- | --- | --- | --- | --- | --- |
| Ketone | 0 Neg | 5 | 15 | 50 | 150 |
| Candidate Device | | | | | |
| 0 Neg | 360 | 2 | | | |
| 5 | 36 | 69 | 2 | | |
| 15 | 1 | 3 | 80 | 6 | |
| 50 | | | 1 | 81 | 1 |
| 150 | | | | 3 | 65 |
| Total | 397 | 74 | 83 | 90 | 66 |
| %Agreement (Exactly match) | 91 | 93 | 96 | 90 | 99 |
| %Agreement (+/- 1 Color Block) | 100 | 100 | 100 | 100 | 100 |
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| | Predicate Device | | | | |
| --- | --- | --- | --- | --- | --- |
| Glucose | Norm | 50 | 100 | 250 | 1000 |
| Candidate Device | | | | | |
| Norm | 121 | 2 | | | |
| 50 | 3 | 68 | 8 | | |
| 100 | | 2 | 89 | 4 | |
| 250 | | | 2 | 73 | 4 |
| 1000 | | | 1 | | 102 |
| Total | 124 | 72 | 100 | 77 | 106 |
| %Agreement (Exactly match) | 98 | 94 | 89 | 95 | 96 |
| %Agreement (+/- 1 Color Block) | 100 | 100 | 99 | 100 | 100 |
| | Predicate Device | | | | |
| --- | --- | --- | --- | --- | --- |
| Protein | Neg | 15 | 30 | 100 | 500 |
| Candidate Device | | | | | |
| Neg | 310 | 5 | 1 | | |
| 15 | 26 | 73 | 13 | | |
| 30 | 1 | 5 | 146 | 16 | |
| 100 | | | 3 | 123 | 1 |
| 500 | | | | 3 | 63 |
| Total | 337 | 83 | 163 | 142 | 64 |
| %Agreement (Exactly match) | 92 | 88 | 90 | 87 | 98 |
| %Agreement (+/- 1 Color Block) | 100 | 100 | 99 | 100 | 100 |
| | Predicate Device | | | |
| --- | --- | --- | --- | --- |
| Bilirubin | Neg | 1 | 3 | 6 |
| Candidate Device | | | | |
| Neg | 301 | 4 | | |
| 1 | 26 | 142 | | |
| 3 | | 18 | 87 | 3 |
| 6 | | | 10 | 68 |
| Total | 327 | 164 | 97 | 71 |
| %Agreement (Exactly match) | 92 | 87 | 90 | 96 |
| %Agreement (+/- 1 Color Block) | 100 | 100 | 100 | 100 |
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| | Predicate Device | | | | |
| --- | --- | --- | --- | --- | --- |
| Urobilinogen | Norm | 1 | 4 | 8 | 12 |
| Candidate Device | | | | | |
| Norm | 419 | | | | |
| 1 | 36 | 61 | 1 | | |
| 4 | | 2 | 62 | 4 | |
| 8 | | | 2 | 68 | 5 |
| 12 | | | | 2 | 67 |
| Total | 455 | 63 | 65 | 74 | 72 |
| %Agreement (Exactly match) | 92 | 97 | 95 | 92 | 93 |
| %Agreement (+/- 1 Color Block) | 100 | 100 | 100 | 100 | 100 |
| | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| pH | 5.0 | 6.0 | 6.5 | 7.0 | 8.0 | 9.0 |
| Candidate Device | | | | | | |
| 5.0 | 228 | 2 | | | | |
| 6.0 | 29 | 110 | 22 | 1 | | |
| 6.5 | | 7 | 93 | 11 | | |
| 7.0 | | | 5 | 118 | 12 | |
| 8.0 | | | | 2 | 101 | 13 |
| 9.0 | | | | | 4 | 75 |
| Total | 257 | 119 | 120 | 132 | 117 | 88 |
| %Agreement (Exactly match) | 89 | 92 | 78 | 89 | 86 | 85 |
| %Agreement (+/- 1 Color Block) | 100 | 100 | 100 | 99 | 100 | 100 |
| | Predicate Device | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Specific Gravity | 1.000 | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| Candidate Device | | | | | | | |
| 1.000 | 9 | 5 | 1 | | | | |
| 1.005 | 4 | 67 | 14 | 1 | | | |
| 1.010 | | 13 | 177 | 36 | 4 | | |
| 1.015 | | | 11 | 141 | 18 | | |
| 1.020 | | | 1 | 8 | 131 | 14 | |
| 1.025 | | | | 0 | 10 | 92 | 5 |
| 1.030 | | 1 | | 1 | | 2 | 70 |
| Total | 13 | 86 | 204 | 187 | 163 | 108 | 75 |
| %Agreement (Exactly match) | 69 | 78 | 87 | 75 | 80 | 85 | 93 |
| %Agreement (+/- 1 Color Block) | 100 | 99 | 99 | 99 | 98 | 100 | 100 |
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# Summary of Data
| Analyte | % Agreement (within ± 1 color block) | % Agreement (exact match) | Analyte | % Agreement (within ± 1 color block) | % Agreement (exact match) |
| --- | --- | --- | --- | --- | --- |
| Blood (Erythrocytes) | 100 (713/713) | 91.7 (654/713) | Protein | 99.8 (788/789) | 90.6 (715/789) |
| Leukocytes | 100 (469/469) | 95.9 (450/469) | Bilirubin | 100 (659/659) | 90.7 (598/659) |
| Nitrite | 100 (190/190) | 96.8 (184/190) | Urobilinogen | 100 (729/729) | 92.8 (677/729) |
| Ketone | 99.7 (708/710) | 90.7 (655/710) | pH | 99.9 (832/833) | 87.0 (725/833) |
| Glucose | 100 (479/479) | 94.6 (453/479) | Specific Gravity | 99.2 (830/836) | 82 (687/836) |
Cobas u411 optional Urine Color parameter vs. Visual Read
| | Visual Reading | | | | |
| --- | --- | --- | --- | --- | --- |
| Urine Color | pale yellow/ yellow | orange | amber | brown | red |
| Candidate Device | | | | | |
| pale yellow/ yellow | 176 | | 6 | | |
| orange | | | | | 2 |
| amber | 12 | | 37 | | |
| brown | 8 | | 36 | 53 | |
| red | | | | | 8 |
b. Matrix comparison:
Not applicable, this device is only used with urine samples.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
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c. Other clinical supportive data (when a. and b. are not applicable):
4. Clinical cut-off:
Not applicable
Expected values/Reference range:
Complete details of the expected analyte values are provided in the labeling.
The labeling states that each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference range.
N. Instrument Name:
Cobas u411 Urinalysis Test System
O. System Descriptions:
1. Modes of Operation:
The Cobas Urinalysis Test system is an automated urine analyzer using reflectance photometry for the semi quantitative determination of Specific Gravity, pH, Leukocyte esterase, Nitrite, Protein, Glucose, Ketones, Urobilinogen, Bilirubin and Erythrocytes.
2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X ☐ or No ☐
3. Specimen Identification:
Numerical specimen identification information can be entered manually via the touch screen keyboard on the analyzer. The analyzer is also available for use with a bar code scanner using the BC scanner interface located in the back of the instrument.
4. Specimen Sampling and Handling:
Cobas u 411 Urinalysis Test system can analyze multiple strips. The user dips the test strip into the urine sample and places it on a sample tray. The test strip is then drawn inside the analyzer to begin timing and analysis.
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5. Calibration:
Calibration is based on the analysis of a calibration strip with known reflectance values. The calibration strip is initially provided with the device and may also be purchased separately. This internal calibration strip must be replaced at least once a year or in the event that the cobas u 411 analyzer cannot be calibrated. This must only be performed using the Control-Test M calibration strip manufactured by Roche Diagnostics. The calibration strip is made of gray plastic material of constant reflectance characteristics. Labeling recommends that the cobas u411 analyzer be calibrated once every four weeks.
6. Quality Control:
Quality Control is analyzed like the patient samples. The labeling recommends that a positive and a negative external control be assayed daily according to state, federal and local guidelines and 1) when starting a new lot of test strips 2) when starting a new container of test strips 3) when there are questionable results 4) every 30 days to check the storage conditions of the test strips 5) after using the calibration strip 6) after maintenance or service and 7) when changing operators.
P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
R. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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