URYXXON 200 URINE ANALYZER by MACHEREY-NAGEL GMBH & CO., KG.

The URYXXON® 200 is a portable reflectance photometer that instrumentally measures the reflectance on a reacted Medi-Test Combi 11 Reagent Strip for Urinalysis. The product 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. The test results are used in the evaluation of diabetes, 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 gravity, leucocytes, blood, nitrite, pH, ketones, bilirubin, ascorbic acid and urobilinogen and urine color are considered routine urinalysis.

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.

AI/ML Overview

The provided 510(k) summary for the URYXXON® 200 Urine Analyzer does not contain specific acceptance criteria or detailed study results demonstrating device performance. It primarily focuses on demonstrating substantial equivalence to a predicate device, the CLINITEK® 50 Urine Analyzer.

Therefore, many of the requested sections regarding acceptance criteria, study design, and performance metrics cannot be directly extracted from the provided text. The document refers to "results of clinical testing that demonstrate the substantial equivalence," but these results are not detailed in the summary.

Below is a response based on the available information in the provided text.

Acceptance Criteria and Device Performance

Based on the provided 510(k) summary, specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, or agreement percentages) for each analyte are not explicitly stated. The summary mentions "performance specifications" were presented to the FDA to demonstrate substantial equivalence, but these specifications themselves are not detailed.

The general acceptance criterion implied is that the URYXXON® 200 performs substantially equivalently to the predicate device, the CLINITEK® 50 Urine Analyzer, for the listed analytes.

Table of Acceptance Criteria and Reported Device Performance:

Analyte	Acceptance Criteria (Not Explicitly Stated for this device in the Summary)	Reported Device Performance (Not Explicitly Stated for this device in the Summary)
Blood	Implied: Substantially equivalent to predicate	N/A
Urobilinogen	Implied: Substantially equivalent to predicate	N/A
Bilirubin	Implied: Substantially equivalent to predicate	N/A
Protein	Implied: Substantially equivalent to predicate	N/A
Nitrite	Implied: Substantially equivalent to predicate	N/A
Ketones	Implied: Substantially equivalent to predicate	N/A
Ascorbic Acid	N/A (unique to this device compared to predicate)	N/A
Glucose	Implied: Substantially equivalent to predicate	N/A
pH	Implied: Substantially equivalent to predicate	N/A
Specific Gravity	Implied: Substantially equivalent to predicate	N/A
Leucocytes	Implied: Substantially equivalent to predicate	N/A

Explanation: The document states, "MACHEREY-NAGEL has presented information of the technological principles, performance specifications, indications for use and results of clinical testing that demonstrate the substantial equivalence of the URYXXON® 200 to the predicate devices." However, these "performance specifications" and "results of clinical testing" are not included within the summary itself. Therefore, specific numerical performance figures or explicit acceptance criteria for the URYXXON® 200 cannot be extracted.

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The summary only mentions "results of clinical testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The summary does not provide details on how ground truth was established for the clinical testing mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is a device for instrumental measurement (a reflectance photometer for automated reading of urine test strips), not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The URYXXON® 200 is inherently a "standalone" device in the sense that it performs the measurement automatically without human interpretation of the strips. The summary implies the device's performance was evaluated independently to demonstrate equivalence to the predicate. However, detailed results of this standalone performance are not provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified in the provided summary. For urine chemistry analyzers, ground truth often involves comparison against a reference method (e.g., laboratory wet chemistry or a highly precise manual method) or expert visual interpretation, but the document does not specify.
The sample size for the training set:
- The URYXXON® 200 is a reflectance photometer, not a machine learning or AI algorithm in the contemporary sense that would require a "training set" for model development. Its calibration and measurement principles are based on established photometric methods. Therefore, the concept of a "training set" in the context of AI does not directly apply here.
How the ground truth for the training set was established:
- As explained above, a "training set" as understood in AI/ML is not applicable to this type of device. Calibration of the instrument would be part of its manufacturing and quality control process, established against known standards.

Summary

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510(k) SUMMARY
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K051034

510 (k) SUMMARY

Introduction	According to the requirements established in the Food and Drug Admi-nistration's guidance entitled "The New 510(k) Paradigm: AlternateApproaches to Demonstrating Substantial Equivalence in PremarketNotifications", the following information provides sufficient detail tounderstand the basis for a determination of substantial equivalence.
1) Submittername, address, contact	MACHEREY-NAGEL GmbH & Co. KGValencienner-Strasse 11D-52355 DuerenGERMANY
	Submitter's Name:	Dietmar Czyron
	Contact Person U.S.:	Eduardo MarchPhone: 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, 75KQOClass I ; Urinary Glucose Test System, 75JIL, ClassII
3) Predicate device	We claim substantial equivalence to the currently market CLINITEK® 50Urine 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 forthe 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 clinicallaboratories and point-of-use settings.
6) Comparison topredicate device	The table below indicates the similarities between the URYXXON® 200Urine Analyzer and predicate devices, the CLINITEK® 50 Urine Analyzerand URYSIS 1100 Urine Analyzer

Topic	URYXXON® 200	CLINITEK® 50
Intend of Use	In-vitro semi-quantitative determination of urineanalytes	Same
ScientificTechnology	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, specificgravity and leucocytes	Same, except ascorbicacid

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7) Difference to predicatedevice	The URYXXON® 200 Urine Analyzer additionally measures ascorbicacid (vitamin C).
	Provides high-speed thermo-transfer printer.
8) Statement ofSubstantial Equivalence	MACHEREY-NAGEL has presented information of the techno-logical principles, performance specifications, indications for useand results of clinical testing that demonstrate the substantialequivalence of the URYXXON® 200 to the predicate devices.

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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).

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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

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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)

Regulation Number and Section

§ 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.