(334 days)
Not Found
No
The description focuses on chemical analysis of urine using test strips and does not mention any AI/ML components or image processing.
No
The device is described as a diagnostic tool for determining various chemical parameters in urine, indicating early symptoms of diseases, rather than providing therapy or treatment.
Yes
The device is described as being for "rapid determination" of various substances in urine, and it indicates "early symptoms of three great groups of diseases," which are explicit diagnostic purposes.
No
The device description explicitly states "The urine test strips can be used...", indicating a physical component (test strips) is integral to the device's function. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, and Leukocytes in urine." This involves testing a sample (urine) taken from the human body to provide information about a person's health status.
- Device Description: The description further elaborates on how the device is used to determine the "complete chemical urine status" and indicates its use in identifying "early symptoms of three great groups of diseases." This aligns with the purpose of IVD devices, which are used to diagnose or aid in the diagnosis of diseases or conditions.
- Anatomical Site: The device is used with "urine," which is a biological sample from the human body.
- Performance Studies: The document mentions "results of studies and comparisons" and "accuracy study," which are typical for demonstrating the performance of an IVD device.
- Predicate Device: The inclusion of a "Predicate Device(s)" with a K number (K991927) and name (Medi-Test Combi 11) strongly indicates that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used to demonstrate substantial equivalence to a legally marketed device.
All these factors point to this device being an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
JMA, JJB, JIN, JMT, JR, CDM, CEN, JIL, JIP
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.
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
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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
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- 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
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- Equivalent legally marketed device: Medi-Test Combi 11, K991927, Macherey-Nagel-Duren
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- 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)
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- Illness of liver and haemolytic disorders.
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- 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 of
Bilirubin, Urobilinogen,
Ketones, Glucose, Protein,
Blood, Nitrite, pH-Value,
Specific Gravity,
Leukocytes, and Ascorbic
Acid in urine. | SAME
(Model 10SL does not have
the Ascorbic Acid test) |
| Method | Dip in urine, check against
color chart | SAME |
| Time | 60 Sec | SAME |
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- 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 (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
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