(284 days)
Not Found
No
The summary describes a standard automated urine test strip analyzer and does not mention any AI or ML capabilities.
No
The device is an analyzer that determines chemical parameters from urine samples. It is used to aid in the evaluation and diagnosis of various medical conditions, but it does not directly treat or prevent a disease.
Yes
The device is used to determine parameters from urine, and these measurements are used in the "evaluation of diabetes, liver diseases, haemolytic diseases, urogenital and kidney disorders or metabolic abnormalities," which are all diagnostic purposes.
No
The device description explicitly states it is a "medium automated urine test strip analyser," which implies a physical hardware component that analyzes the test strips. It is not described as purely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "determine the following parameters from urine" using "Combi Screen test strips." This involves testing a sample (urine) taken from the human body in vitro (outside the body).
- Purpose: The measurements are used "in the evaluation of diabetes, liver diseases, haemolytic diseases, urogenital and kidney disorders or metabolic abnormalities." This indicates the device is used for diagnostic purposes, providing information to aid in the diagnosis or evaluation of medical conditions.
- Device Description: The description reinforces that it's a "urine test strip analyser" that determines parameters from urine.
These points clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The Combi Scan 500 is for use with Combi Screen test strips to determine the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity, urobilinogen. These measurements are used in the evaluation of diabetes, liver diseases, haemolytic diseases, urogenital and kidney disorders or metabolic abnormalities. For professional use only, not for self testing!
Product codes
JIL, JIO, JMA, LJX, JRE, CEN, JMT, JIR, JIN, CDM, JJB, KQO
Device Description
The Combi Scan 500 is a medium automated urine test strip analyser for use with Combi Screen test strips to determine one or more of the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity. For professional use only!
Mentions image processing
The instrument measures the color of the light that is reflected from the test pads on the strip (reflectometric evauation). These data are converted into meaningful results.
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
For professional use only, not for self testing!
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Clinitec 50, K960546
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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L061812
Analyticon Biotechnologies AG
35104 Lichtenfels, Germany
date: 03.04.2006
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Image /page/0/Picture/3 description: The image contains a logo for a company called "analyticon Biotechnologies AG". The logo consists of a stylized letter "A" in black, with the company name printed in a smaller, sans-serif font below it. The word "analyticon" is on the first line, and "Biotechnologies AG" is on the second line.
- 510(k) Summary
510(k) Submission Combi Scan 500 5. 510(k) Summary
APR - 6 2007
| Introduction | According to the requirements of 21 CFR 807.92, the following
information provides sufficient details to understand the basis for
a determination of substantial equivalence | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 1) 510(k)-Nr. | | |
| 2) Submitter | Analyticon Biotechnologies AG
Am Mühlenberg 10
35104 Lichtenfels
Germany
Phone +49-6454-7991-0
FAX: +49-6454-7991-30
e-mail: info@analyticon.de
www.analyticon.de
Contact Person: Dr. Klaus Langer
Representative in USA:
Kamm & Associates
333 Milford Road, 60015 Deerfield, IL | |
| 2) Device Name | Proprietary Name: Combi Scan 500
Common Name: Automated Urine Analyzer
Classification Name:
Class I (exempt)
21CFR§862.2900: Automated Urine Analyzer (KQO)
Additional Classification:
Class II:
21CFR§862.1340 Urinary Glucose (nonquant.) test system (JIL)
21CFR§864.6550 Occult Blood test (JIP)
Class I exempt:
21CFR§862.1095 Ascorbic acid test system (JMA)
21CFR§862.1115 Urinary bilirubin and its conjugates
(nonquant.) test system (JJB)
21CFR§862.1435 Ketones (nonquant.) test system (JIN)
21CFR§862.1510 Nitrite (nonquant.) test system (JMT)
21CFR§862.1550 Urinary pH (nonquant.) test system (CEN)
21CFR§862.1645 Urinary protein or albumin (nonquant.) test
system (JIR)
21CFR§862.1785 Urinary urobilinogen (nonquant.) test system
(CDM)
21CFR§864.7675 Leukocyte peroxidase test | |
| 3) Predicative Device | Clinitec 50 (+ Multistix), Bayer (KQO)
510(k)-Nr. K960546 | |
| | | |
| 4) Device Description | The Combi Scan 500 is a medium automated urine test strip
analyser for use with Combi Screen test strips to determine one
or more of the following parameters from urine: ascorbic acid,
bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein,
specific gravity. For professional use only! | |
| 5 ) Intended Use | Instrument for measurement of urine test strips Combi Screen
for in-vitro determination of Ascorbic acid, Bilirubin, Blood,
Glucose, Ketones, Leukocytes, Nitrite, pH, Protein, Specific
Gravity, and Urobilinogen from urine.
For professional use, not for self testing. | |
| 6) Comparison to | The table below shows similarities and differences to the | |
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Image /page/1/Picture/0 description: The image shows a logo for analyticon Biotechnologies AG. The logo features a stylized letter "A" above the company name. The text "analyticon" is in a bold, sans-serif font, and "Biotechnologies AG" is in a smaller font below it.
Analyticon Biotechnologies AG 35104 Lichtenfels, Germany
510(k) Submission Combi Scan 500 5. 510(k) Summary
predicative device
predicative device
| Feature | Combi Scan 500 | Clinitek 50 |
|---|---|---|
| Intended use | Instrument for measurement of urine test strips | |
| Combi Screen for in-vitro determination of | ||
| Ascorbic acid, Bilirubin, Blood, Glucose, | ||
| Ketones, Leukocytes, Nitrite, pH, Protein, | ||
| Specific Gravity, and Urobilinogen from urine. | ||
| For professional use, not for self testing. | The Clinitek 50 urine chemistry analyser is for | |
| use with Bayer reagent strips for the | ||
| determination of glucose, bilirubin, ketone, | ||
| blood, protein, urobilinogen, nitrite and | ||
| leucocytes in urine, urine pH, specific gravity | ||
| and colour. The tests on bayer Reagent strips | ||
| and urine color are considered routine | ||
| urinalysis. | ||
| General design | Bench-top instrument | Bench-top instrument |
| Energy source | Power transformer | |
| Input: 100 - 240 V, 50/60 Hz | ||
| Output. 7,5V, 3,0 A | Power transformer | |
| Input: 100 - 250 V, 50/60 Hz | ||
| Output. 9V, 2,78 A | ||
| Measurement | ||
| technology | The instrument measures the color of the light | |
| that is reflected from the test pads on the strip | ||
| (reflectometric evauation). These data are | ||
| converted into meaningful results. | The instrument measures the color and | |
| amount of light that is reflected from the test | ||
| pads on the strip (reflectometric | ||
| measurement). It then converts these | ||
| measurements to meaningful results. | ||
| Measuring | ||
| operation | The test strip is dipped into the urine and | |
| placed on a conveyor, which moves the strip | ||
| into the instrument. The instrument controls the | ||
| incubation time and does the measurement. | The test strip is dipped into the urine and | |
| placed on the strip holder in front of the | ||
| instrument. Then, the strip holder is moved into | ||
| the instrument, which controls the incubation | ||
| time and does the measurement. | ||
| Analytes | Test strip Combi Screen 11SYS: | |
| Ascorbic acid, Bilirubin, Blood, Glucose, | ||
| Ketones, Leukocytes, Nitrite, pH, Protein, | ||
| Specific Gravity, and Urobilinogen from urine. | Test strip Multistix 10SG: | |
| Bilirubin, Blood, Glucose, Ketones, | ||
| Leukocytes, Nitrite, pH, Protein, Specific | ||
| Gravity, and Urobilinogen from urine. | ||
| Controlling of | ||
| the system | LCD-Display, buttons below the display to | |
| control the instrument. | LCD-Display, buttons below the display to | |
| control the instrument. | ||
| Storage of | ||
| results | Storage of 999 measurements possible | Storage of measurements possible |
| Printing of | ||
| results | Printout with results, date & time on thermal | |
| paper by internal printer | Printout with results, date & time on thermal | |
| paper by internal printer |
- Statement of substantially equivalence
Analyticon has submitted Information that shows the substantial equivalence to the predicative device.
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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is in a simple, sans-serif font.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Analyticon Biotechnologies AG c/o Mr. Jeff D. Rongero Underwriters Laboratories Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709-3995
APR - 6 2007
Re: K061812 Trade/Device Name: Combi Scan 500 Regulation Number: 21 CFR §862.1340 Regulation Name: Urinary glucose (non-quantitative) test system. Regulatory Class: Class II Product Code: JIL, JIO, JMA, LJX, JRE, CEN, JMT, JIR, JIN, CDM, JJB & KQO Dated: March 21, 2007 Received: March 22, 2007
Dear Mr. Rongero:
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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Sean M. Cooper, M.S., D.V.M. 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):
Device Name:
Combi Scan 500
Indications For Use:
The Combi Scan 500 is for use with Combi Screen test strips to determine the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity, urobilinogen. These measurements are used in the evaluation of diabetes, liver diseases, haemolytic diseases, urogenital and kidney disorders or metabolic abnormalities. For professional use only, not for self testing!
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NA (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)
Carol C. Benam
Office of In Vitro Diagnostic Device Evaluation and Safety
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