COMBI-SCREEN, MODELS 10SL AND 11SL

K023885 · Analyticon Biotechnologies AG · JIL · Oct 21, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023885
• Device Name: COMBI-SCREEN, MODELS 10SL AND 11SL
• Applicant: Analyticon Biotechnologies AG
• Product Code: JIL · Clinical Chemistry
• Decision Date: Oct 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Intended Use

The urine test strips may be used for rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH, Specific Gravity and Leukocytes in urine for the model 10SL, plus Ascorbic acid in urine for the Model 11SL.

Device Story

Combi-Screen Urine Test Strips (Models 10SL and 11SL) are diagnostic strips for semi-quantitative or qualitative chemical urine analysis. User dips strip into urine sample; colorimetric reaction occurs on reagent pads; user compares resulting colors against a provided color chart after 60 seconds. Device provides rapid screening for carbohydrate metabolism disorders (diabetes), kidney/urinary tract infections, and liver/haemolytic disorders. Used in clinical settings or point-of-care; operated by healthcare professionals. Output allows clinicians to assess patient's chemical urine status, aiding in early detection of disease symptoms.

Clinical Evidence

Clinical study conducted at three medical centers comparing Combi-Screen to Chemstrip 10 using fresh, uncentrifuged urine samples (N=128, 102, 185). Primary endpoints included sensitivity, specificity, predictive values, and efficiency. Results showed high concordance; blood sensitivity ranged 76.5%–93.2% and specificity 97.3%–100%; glucose sensitivity ranged 83.3%–100% and specificity 97.4%–100%.

Technological Characteristics

Urine dipstick with multiple reagent pads. Glucose detection via glucose oxidase/peroxidase chromogen; blood detection via pseudoperoxidative activity of hemoglobin/myoglobin. Visual readout against color chart. No electronic components, connectivity, or software.

Indications for Use

Indicated for rapid qualitative determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH, Specific Gravity, Leukocytes, and Ascorbic acid (Model 11SL only) in human urine.

Regulatory Classification

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.

Predicate Devices

• Medi-Test Combo 11 Macherey-Nagel-Duren (K991927)

Submission Summary (Full Text)

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K023885

OCT 2 1 2003

## EXHIBIT 2 ANALYTICON Biotechnologies AG Am Mühlenberg 10 D-35104 Lichtenfels Germany Phone: [phone] Fax: [phone] 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
- 2. Equivalent legally marketed device: Medi-Test Combi 11, K991927, Macherey-Nagel-Duren
- 3. 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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- 5. Safety and Effectiveness, comparisons to predicate devices: Medi-Test Combi 11, K991927, Macherey-Nagel-Duren

| Characteristic | Medi-Test Combi 11,<br>K991927, Macherey-Nagel-<br>Duren | Combi-Screen® |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Indication | For rapid determination of<br>Bilirubin, Urobilinogen,<br>Ketones, Glucose, Protein,<br>Blood, Nitrite, pH-Value,<br>Specific Gravity,<br>Leukocytes, and Ascorbic<br>Acid in urine. | SAME<br>(Model 10SL does not have<br>the Ascorbic Acid test) |
| Method | Dip in urine, check against<br>color chart | SAME |
| Time | 60 Sec | SAME |

- 6. 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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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 [phone]. 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 [phone] or [phone] 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