(136 days)
Not Found
No
The description focuses on standard photometric measurements and data handling, with no mention of AI/ML terms or capabilities.
No
The device is an in vitro diagnostic (IVD) analyzer used for measuring analytes in urine to evaluate disorders, not for direct therapy.
Yes
The device is explicitly stated to be for "in vitro diagnostic use only" and its measurements are "useful in the evaluation of renal, urinary and metabolic disorders," which indicates its role in diagnosing diseases.
No
The device description explicitly states it is a "semi-automated, benchtop analyzer," which is a physical hardware device designed to read test strips.
Yes, the provided text explicitly states that the cobas u 411 urine analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The text clearly states, "Tests performed using the cobas u411 are intended for prescription, in vitro diagnostic use only."
- Device Description: The text reiterates this in the device description: "Tests performed using the cobas u411 are intended for prescription, in vitro diagnostic use only."
These statements directly identify the device's intended use as in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JIL, JIO, CDM, CEN, JIN, JIR, JMT, JJB, LJX, CEN, JRE, KQO
Device Description
The cobas u 411 urinalysis test system is substantially equivalent to other devices legally marketed in the United States. 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| (317) 521-4569 |
Contact Person: Jennifer Tribbett
Date Prepared: March 24, 2010 |
| Device Name | Proprietary name: (1) Chemstrip 10 UA
(2) cobas u 411 Urine Analyzer
Common name: (1) Reagent Strip for urinalysis
(2) Automated Urinalysis System
Classification 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 |
1
| Classification Name | Classification
Number | Panel Name | Exempt | Device
Class | Regulation
Citation |
|--------------------------------------------------------------|--------------------------|--------------------------|--------|-----------------|------------------------|
| Diazonium Colorimetry,
urobilinogen (urinary, non-quant) | CDM | 75 Clinical
Chemistry | YES | I | 21 CFR
862.1785 |
| Dye-Indicator, pH (Urinary, non-
quant) | CEN | 75 Clinical
Chemistry | YES | I | 21 CFR
862.1550 |
| Nitroprusside, ketones (urinary, non-
quant) | JIN | 75 Clinical
Chemistry | YES | I | 21 CFR
862.1435 |
| Indicator method, protein or albumin
(urinary, non-quant) | JIR | 75 Clinical
Chemistry | YES | I | 21 CFR
862.1645 |
| Diazo (colormetric), Nitrite
(Urinary, non-quant) | JMT | 75 Clinical
Chemistry | YES | I | 21 CFR
862.1510 |
| Test, Urine Leukocyte | LJX | 82
Hematology | YES | I | 21 CFR
864.7675 |
| Azo-dyes, colormetric, bilirubin &
its con | JJB | 75 Clinical
Chemistry | YES | I | 21 CFR
862.1115 |
| Automated Urinalysis System | KQO | 75 Clinical
Chemistry | YES | I | 21 CFR
862.2900 |
| Refractometer for clinical use | JRE | 75 Clinical
Chemistry | YES | I | 21 CFR
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
2
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 a
semiautomated, computerized analyzer
intended for the in vitro semi-
quantitative determination of urine
analytes, including specific gravity
(SG), pH, leukocytes, nitrite, protein,
glucose, ketones, urobilinogen,
bilirubin and erythrocytes
Note: A compensation pad is provided
to aid in the correction of interference
from the intrinsic color of urine. | 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. |
| 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 |
| Feature | Chemstrip Urine Analyzer
(predicate) | cobas u 411 urinalysis test system
(proposed) |
| Test Principle | pH: color change with the indicators
methyl red and bromthymol blue.
Leukocytes: esterase cleaves an indoxyl
ester, and the indoxyl reacts with a
diazonium salt to produce a purple color.
Nitrite: based on the principle of the
Griess test. Nitrite, if present, reacts with
an aromatic amine to give a diazonium salt
which yields a red-violet azo dye.
Protein: based on the "protein error of pH
indicators" involving tetrachlorophenol-
tetrabromosulfophthalein
Glucose: based on the specific glucose
oxidase/peroxidase reaction (GOD/POD
method).
Ketone: based on the principle of Legal's
test involving use of sodium nitroprusside.
Urobilinogen: Urobilinogen is coupled
with 4-methoxybenzene-diazonium-
tetrafluoroborate in an acid medium to
form a red azo dye.
Bilirubin: based on the coupling of
bilirubin with a diazonium salt.
Blood: The peroxidase-like action of hgb
and myoglobin catalyzes the oxidation of
the indicator by the organic peroxide.
Specific Gravity: In the presence of
cations, protons are released by a
complexing agent in the test and produce a
color change | Same |
| Feature | Chemstrip Urine Analyzer (predicate) | cobas u 411 urinalysis test system (proposed) |
| Measuring Unit | Light Emitting Diodes (LEDs)
Wavelength:
Orange: 620 nm
Green: 555 nm
Red: 660 nm
Reader Head: 2 heads with 3 LEDs each | Light Emitting Diodes (LEDs)
Wavelength:
Orange: 620 nm
Green: 555 nm
Blue: 470 nm
Sensor: 11 wide range photo sensors |
| Operating Conditions | Temperature:
•operational: 15 - 34 °C
•storage: -20 - 60 °C
Humidity:
•operational: 20 - 80%
•storage: 20 - 95% | Temperature:
•operational: 15 - 32 °C
•storage: -25 - 60 °C
Humidity:
•operational: 30 - 80%
•storage: 10 - 95% |
| Storage Medium | Floppy Disks | USB Stick |
| Strip Detector | One strip detector | Two strip detectors |
3
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4
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. ・・
5
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).
6
Page 2
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
7
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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