(12 days)
Not Found
No
The description focuses on hardware modifications and standard photometric analysis, with no mention of AI or ML algorithms for data interpretation or analysis.
No
The device is a urine analyzer, which is an in vitro diagnostic device used for reading and evaluating urine test strips. It does not provide any therapy or treatment to a patient.
Yes
The device is designed to "read and evaluate the results of urine test strips for various urine analytes," which indicates it is used to diagnose conditions based on these biological measurements.
No
The device description clearly outlines physical hardware components such as external housing, a thermal printer, a test strip transport mechanism with a cog wheel drive and tray, and a measurement head containing LEDs. This indicates it is a physical device, not software-only.
Yes, the Urisys 1100 Urine Analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that it is designed to "automatically read and evaluate the results of Chemstrip... urine test strips for various urine analytes." This involves testing biological samples (urine) outside of the body to provide information about a person's health status.
- Device Description: The description details a device that analyzes chemical reactions on test strips, which is a common method for in vitro diagnostics.
- Predicate Devices: The predicate devices listed (Chemstrip 101 Urine Analyzer) are also IVD devices, indicating that this device falls within the same regulatory category.
Therefore, based on the provided information, the Urisys 1100 Urine Analyzer clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Urisys 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7 and Chemstrip 10 MD urine test strips for various urine analytes: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood.
Product codes (comma separated list FDA assigned to the subject device)
JIL, KHE, KQO
Device Description
The Urisys 1100 Urine Analyzer is a modification of the previously cleared Chemstrip 101.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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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
§ 864.6550 Occult blood test.
(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
NOV 2 4 2003
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. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Rd.
Indianapolis, IN 46250 |
| | Contact Person: Jennifer Tribbett |
| | Date Prepared: November 11, 2003 |
| 2) Device name | Proprietary name: Roche Diagnostics Urisys 1100™ Urine Analyzer
Common name: Automated Urinalysis System
Classification name: Automated Urinalysis System |
| 3) Predicate
device | The Urisys 1100 Urine Analyzer is substantially equivalent to the current
legally marketed Chemstrip 101 Urine Analyzer. Chemstrip 101 Urine
Analyzer was originally cleared for use with the Chemstrip 10 UA test strips
under K983510. The Chemstrip 10 MD, Chemstrip 7 and Chemstrip 5 OB
test strips were cleared on the Chemstrip 101 Urine Analyzer under K032437. |
| 4) Device
Description | The Urisys 1100 Urine Analyzer is a modification of the previously cleared
Chemstrip 101. |
| 5) Intended use | The Urisys 1100 Urine Analyzer is a reflectance photometer designed to
automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7
and Chemstrip 10 MD urine test strips for various urine analytes: specific
gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen,
bilirubin and blood. |
| 6) Similarities | The table below indicates the similarities between the Urisys 1100 and Chemstrip 101 Urine Analyzers. |
1
| Feature/Claim | Urisys 1100 Urine Analyzer | Chemstrip 101 Urine Analyzer |
|---|---|---|
| Intended Use | Reflectance photometer designed | |
| to automatically read and evaluate | ||
| the results of Chemstrip 10 MD, | ||
| Chemstrip 7 and Chemstrip 5 OB | Same | |
| Fundamental Technology | Reflectance Photometer | Same |
| Test Parameters | Specific gravity, pH, leukocytes, | |
| nitrite, protein, glucose, ketones, | ||
| urobilinogen, bilirubin and blood | Same | |
| User Interface | To perform a test, simply dip the | |
| test strip in the urine sample, | ||
| gently press the long edge of the | ||
| test strip to a piece of absorbent | ||
| paper for one second, and place it | ||
| in the test strip tray with the pads | ||
| facing upward. Then, press the | ||
| START button. Measurement is | ||
| complete in 70 seconds, and | ||
| results are automatically printed. | Same |
| 7) Modifications | The following table lists the modified features of the Urisys 1100 Urine Analyzer. |
|---|---|
| ------------------ | ------------------------------------------------------------------------------------ |
| Feature/Claim | Description |
|---|---|
| Housing | The external housing was made smaller to give it a more modern design look. |
| Printer | A new integrated, fast and silent thermal printer with automatic paper feed is |
| being introduced with the Urisys 1100. | |
| Transport | The test strip transport has been improved by incorporating a new cog wheel |
| drive and improved test strip tray. | |
| LED | The measurement head will still contain 6 LEDs, and the LEDs (green and |
| orange) used for measurement purposes will not change. However, the red | |
| LED, which is not used as part of the measurement function, is being replaced | |
| with a more common LED. |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.
Ms. Jennifer Tribbett Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
NOV 2 4 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K033548
Trade/Device Name: Urisys 1100 Urine Analyzer Regulation Number: 21 CFR § 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: II Product Code: JIL, KHE, KQO Dated: November 11, 2003 Received: November 12, 2003
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
3
Page 2 -
If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Urisys 1100 Urine Analyzer
Indications for Use:
The Urisys 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7 and Chemstrip 10 MD urine test strips for various urine analytes: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Alberto Sati'
Division Sign-Off
L. Joan Cooper
fice of In Vitro Diagnostic De Evaluation and Safe
510(k) K03 3548 "Special"
Prescription Use J (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)