(214 days)
Not Found
No
The description focuses on standard reflectance photometry for chemical analysis of urine strips and does not mention any AI/ML components or capabilities.
No
This device is a diagnostic tool that measures analytes in urine specimens for the evaluation of various diseases, rather than providing therapy.
Yes
Explanation: The device measures various analytes in urine for the semi-quantitative determination of conditions such as diabetes, liver diseases, and kidney diseases, which are diagnostic purposes.
No
The device description explicitly states it is a "portable reflectance photometer" and a "Urine Analyzer," which are hardware components used to measure reflectance on test strips. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device "instrumentally measures the reflectance on a reacted Medi-Test Combi 11 Reagent Strip for Urinalysis" and is "intended for use on urine specimens for the semi-quantitative determination of blood, urobilinogen, bilirubin, protein, nitrite, ketones, ascorbic acid, glucose, pH, specific gravity and leucocytes." This clearly indicates that the device is used to examine specimens derived from the human body (urine) to provide information for diagnostic purposes (evaluation of various diseases).
- Device Description: The device is described as a "reflectance photometer for in-vitro semi-quantitative reading of Medi-Test Combi 11 urine test strips." "In-vitro" means "in glass" or "in the lab," referring to tests performed outside of the living body, which is a key characteristic of IVDs.
- Anatomical Site: The device is used on "Urine specimens," which are human biological samples.
- Intended User / Care Setting: The device is intended for use in "clinical laboratories and point-of-use settings," which are typical environments for IVD testing.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The URYXXON® 200 fits this definition perfectly.
N/A
Intended Use / Indications for Use
The URYXXON® 200 is a portable reflectance photometer that instrumentally measures. The the reliectance on a reacted mour root online and using urine specimens for product is intended for use an in hard dities, liver diseases, biliary and hepatic obstructions and diseases of the kidneys and urinary tract.
The test provided on Macherey-Nagel Reagent Strips for the determination of specific The lest provided on Macheroy Ning blood, nitrite, pH, ketones, bilirubin, ascorbic acid and urobilinogen and urine color are considered routine urinalysis
Product codes (comma separated list FDA assigned to the subject device)
JIL, JIP, CDM, CEN, JIN, JIR, JJB, JMA, JMT, KSL, LJX, KQO
Device Description
The URYXXON® 200 Urine Analyzer is a reflectance photometer for in-vitro semi-quantitative reading of Medi-Test Combi 11 urine test strips for the following analytes: blood, urobilinogen, bilirubin, protein, nitrite, ketones, ascorbic acid, glucose, pH, specific gravity and leucocytes.
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
In-vitro, semi-quantitative determination of urine analytes in clinical laboratories and point-of-use settings.
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)
MACHEREY-NAGEL has presented information of the techno-logical principles, performance specifications, indications for use and results of clinical testing that demonstrate the substantial equivalence of the URYXXON® 200 to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 862.1340 Urinary glucose (nonquantitative) test system.
(a)
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.(b)
Classification. Class II.
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510(k) SUMMARY
Page 1 / 2
510 (k) SUMMARY
| Introduction | According to the requirements established in the Food and Drug Admi-
nistration's guidance entitled "The New 510(k) Paradigm: Alternate
Approaches to Demonstrating Substantial Equivalence in Premarket
Notifications", the following information provides sufficient detail to
understand the basis for a determination of substantial equivalence. | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| 1) Submitter
name, address, contact | MACHEREY-NAGEL GmbH & Co. KG
Valencienner-Strasse 11
D-52355 Dueren
GERMANY | |
| | Submitter's Name: | Dietmar Czyron |
| | Contact Person U.S.: | Eduardo March
Phone: 301-838-3120 Facs.: 301-838-3182 |
| | Date Prepared: March 14, 2005 | |
| | Proprietary Name: | URYXXON® 200 |
| | Common Name: | Urine Chemistry Analyzer |
| | Classification Name: | System, Automated Urinalysis, 75KQO
Class I ; Urinary Glucose Test System, 75JIL, Class
II |
| 3) Predicate device | We claim substantial equivalence to the currently market CLINITEK® 50
Urine Analyzer, manufactured by Bayer Corp. (K960546). | |
| 4) Device Description | The URYXXON® 200 Urine Analyzer is a reflectance photometer for in-
vitro semi-quantitative reading of Medi-Test Combi 11 urine test strips for
the following analytes: blood, urobilinogen, bilirubin, protein, nitrite,
ketones, ascorbic acid, glucose, pH, specific gravity and leucocytes. | |
| 5) Intended use | In-vitro, semi-quantitative determination of urine analytes in clinical
laboratories and point-of-use settings. | |
| 6) Comparison to
predicate device | The table below indicates the similarities between the URYXXON® 200
Urine Analyzer and predicate devices, the CLINITEK® 50 Urine Analyzer
and URYSIS 1100 Urine Analyzer | |
| Topic | URYXXON® 200 | CLINITEK® 50 |
|---|---|---|
| Intend of Use | In-vitro semi-quantitative determination of urine | |
| analytes | Same | |
| Scientific | ||
| Technology | Reflectance Photometer | Same |
| Urine Test Strips | Medi-Test Combi 11 (K991927) | Bayer MULTISTIX® |
| 10-SG | ||
| Test Parameters | Blood, urobilinogen, bilirubin, protein, nitrite, | |
| ketones, ascorbic acid, glucose, pH, specific | ||
| gravity and leucocytes | Same, except ascorbic | |
| acid |
1
| 7) Difference to predicate
device | The URYXXON® 200 Urine Analyzer additionally measures ascorbic
acid (vitamin C). |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Provides high-speed thermo-transfer printer. |
| 8) Statement of
Substantial Equivalence | MACHEREY-NAGEL has presented information of the techno-
logical principles, performance specifications, indications for use
and results of clinical testing that demonstrate the substantial
equivalence of the URYXXON® 200 to the predicate devices. |
·
:
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with stylized wings.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 2 2005
Macherey-Nagel GmbH & Co. KG c/o Mr. Eduardo March Senior Consultant AAC Consulting Group 7361 Calhoun Place, Suite 500 Rockville, MD 20855-2765
K051034 Re:
Trade/Device Name: URYXXON 200 Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL, JIP, CDM, CEN, JIN, JIR, JJB, JMA, JMT, KSL, LJX, KQO Dated: October 21, 2005 Received: October 21, 2005
Dear Mr. March:
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).
3
Page 2 -
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.
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto
Alberto Gutierrez, Ph.D.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
URYXXON_200 Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The URYXXON® 200 is a portable reflectance photometer that instrumentally measures. The The ORTAXON 20015 a reacted Medi-Test Combi 11 Reagent Strip for Urinalysis. The the reliectance on a reacted mour root online and using urine specimens for product is intended for use an in hard dities, liver diseases, biliary and hepatic obstructions and diseases of the kidneys and urinary tract.
The test provided on Macherey-Nagel Reagent Strips for the determination of specific The lest provided on Macheroy Ning blood, nitrite, pH, ketones, bilirubin, ascorbic acid and urobilinogen and urine color are considered routine urinalysis
Sign Off
Division Sign-Off
AND/OR
Office of In Vitro Diagnostic Device Office tion and Safety
310(k) Ko51034
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 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)