COMBI-SCREEN, MODELS 10SL AND 11SL by ANALYTICON BIOTECHNOLOGIES AG

Model 10SL: For rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, and Leukocytes in urine
Model 11SL: For rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, Leukocytes, and Ascorbic Acid in urine.

Device Description

The urine test strips can be used for the determination of the complete chemical urine status with the parameters: bilirubin, blood, ketones, glucose, leukocytes, nitrite, pH-value, protein, urobilinogen. In addition the specific gravity can be tested. With it early symptoms of three great groups of diseases can be indicated:
Disorders of the carbohydrate metabolism (diabetes)
Illness of the kidney and urinary passages (e.g. infections of urinary passages, tumors, glomerulonephritis, pyelonephritis)
Illness of liver and haemolytic disorders.

AI/ML Overview

The provided text is a 510(k) summary for the Combi-Screen Urine Test Strips. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results and acceptance criteria in the same way one might for a novel diagnostic device.

Therefore, the information available is limited regarding explicit acceptance criteria and a structured study proving those criteria are met for the new device. The submission primarily relies on comparison to the predicate device and a general statement about accuracy.

Based on the provided text, here's what can be extracted:

Acceptance Criteria and Device Performance

The submission does not explicitly state quantitative acceptance criteria (e.g., specific sensitivity/specificity thresholds, agreement percentages with a gold standard) for each analyte for the Combi-Screen Urine Test Strips. Instead, it relies on demonstrating equivalence to the predicate device and the general statement that "They did not observe any false-negative or false-positive results." This implies that the 'acceptance criteria' are implicitly that the new device performs at least as well as the predicate device and other commercially available strips, without significant errors.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Overall Performance	Performance equal to or better than the predicate device (Medi-Test Combi 11) and other market urine test strips (Roche, Dade-Behring, Bayer, Macherey-Nagel); no false-negative or false-positive results.	"The results of the accuracy study show that the test strips Combi-Screen have got the equal properties in principle like the test strips of the manufacturers: Roche, Dade-Behring, Bayer, Macherey-Nagel. They did not observe any false-negative or false-positive results."
Indication for Use	Same as predicate device.	Same (Model 10SL does not have the Ascorbic Acid test).
Method	Dip in urine, check against color chart (same as predicate).	Same.
Time	60 seconds (same as predicate).	Same.

Additional Information (Based on provided text):

Sample size used for the test set and the data provenance: The document does not specify the sample size for the test set. The data provenance is not explicitly mentioned (e.g., country of origin), and it's unclear if the study was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document.
Adjudication method for the test set: This information is not provided in the document.
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 device is a manual urine test strip, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a manual urine test strip that relies on human visual interpretation of color changes. It is not an algorithm-only device. "Standalone" performance in this context would refer to the strip's chemical reaction accuracy rather than an algorithm's.
The type of ground truth used: The document states "accuracy study" and comparison to "test strips of the manufacturers: Roche, Dade-Behring, Bayer, Macherey-Nagel." This implies that the ground truth was likely established by comparing the results of the Combi-Screen strips against established, perhaps laboratory-based, methods or other gold-standard urine analysis methods (though not explicitly stated as pathology or outcomes data). The phrase "They did not observe any false-negative or false-positive results" suggests a comparison against known positive and negative samples, or against reference methods.
The sample size for the training set: The document does not specify a training set as this is not an AI/machine learning device. The "accuracy study" would typically involve a test set.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary

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K023885

OCT 2 1 2003

EXHIBIT 2 ANALYTICON Biotechnologies AG Am Mühlenberg 10 D-35104 Lichtenfels Germany Phone: 49-6454-7991-0 Fax: 49-6454-7991-30 November 20, 2002 Contact: Umesh Bhalla, Vice President 510(k) Summary of Safety and Effectiveness

1. Identification of the Device: Proprietary-Trade Name Combi-Screen Urine Test Strips (Models 10SL and 11SL) Classification Names: Regulatory Class: I Product Code: JMA, JJB, JIN, JMT, JR, CDM, CEN Regulatory Class: II Product Code: JIN Common/Usual Name: Urine Test Strips
1. Equivalent legally marketed device: Medi-Test Combi 11, K991927, Macherey-Nagel-Duren
1. Indications for Use (intended use) . Model 10SL: For rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, and Leukocytes in urine Model 11SL: For rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, Leukocytes, and Ascorbic Acid in urine.
Description of the Device: The urine test strips can be used for the determination of ধ ..
বাঁ the complete chemical urine status with the parameters: bilirubin, blood, ketones, glucose, leukocytes, nitrite, pH-value, protein, urobilinogen. In addition the specific gravity can be tested. With it early symptoms of three great groups of diseases can be indicated:
- - Disorders of the carbohydrate metabolism (diabetes)
- - Illness of the kidney and urinary passages (e.g. infections of urinary passages, tumors, glomerulonephritis, pyelonephritis)
- - Illness of liver and haemolytic disorders.

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1. Safety and Effectiveness, comparisons to predicate devices: Medi-Test Combi 11, K991927, Macherey-Nagel-Duren

Characteristic	Medi-Test Combi 11,K991927, Macherey-Nagel-Duren	Combi-Screen®
Indication	For rapid determination ofBilirubin, Urobilinogen,Ketones, Glucose, Protein,Blood, Nitrite, pH-Value,Specific Gravity,Leukocytes, and AscorbicAcid in urine.	SAME(Model 10SL does not havethe Ascorbic Acid test)
Method	Dip in urine, check againstcolor chart	SAME
Time	60 Sec	SAME

1. Conclusion: The Combi-Screen® has intended use and technological characteristics that are nearly identical to the predicate device. The results of studies and comparisons show the equal properties of the Combi-Screen test strips and of others market urine test strips in principle. The results of the accuracy study show that the test strips Combi-Screen have got the equal properties in principle like the test strips of the manufacturers: Roche, Dade-Behring, Bayer, Macherey- Nagel. They did not observe any false-negative or false-positive results.

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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 features a stylized image of three faces in profile, one behind the other. The faces are connected by a flowing, ribbon-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circle around the image.

OCT 2 1 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Analyticon Biotechnologies AG c/o Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, IL 60015

Re: K023885

Trade/Device Name: Combi-Screen Urine Test Strips (Models 10SL and 11SL) Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: Class II Product Code: JIL; JIP Dated: July 23, 2003 Received: July 25, 2003

Dear Mr. Kamm:

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 (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

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j) Indications for Use

KO23885 510(k) Number

Device Name: Combi-Screen Urine Test Strips (Models 10SL and 11SL)

Indications for Use: Combi-Screen Urine Test Strips

Model 10SL: For rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, and Leukocytes in urine

Model 11SL: For rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, Leukocytes, and Ascorbic Acid in urine

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OR Over the Counter Use (Per 21 CFR 801.109)

Carl Benavides Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K023885

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.