(284 days)
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No
The summary describes a standard urine test strip analyzer and does not mention any AI or ML capabilities.
No.
The device is used for diagnostic purposes by measuring parameters from urine; it does not directly treat or alleviate a disease or condition.
Yes
The device is used to determine various parameters from urine, which are then used in the "evaluation of diabetes, liver diseases, haemolytic diseases, urogenital and kidney disorders or metabolic abnormalities." This indicates its role in diagnosing or assessing medical conditions.
No
The device description explicitly states it is a "small urine test strip analyser," indicating it is a hardware device that analyzes test strips.
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" and that "These measurements are used in the evaluation of diabetes, liver diseases, haemolytic diseases, urogenital and kidney disorders or metabolic abnormalities." This clearly indicates that the device is used to examine specimens derived from the human body (urine) to provide information for diagnostic purposes.
- Device Description: The device description confirms that it is a "urine test strip analyser for use with Combi Screen test strips to determine one or more of the following parameters from urine." This further supports its use in analyzing biological specimens.
- Professional Use Only: While not a definitive marker of an IVD, the "For professional use only" statement aligns with the typical use of IVDs in clinical or laboratory settings.
The definition of an In Vitro Diagnostic device generally includes devices intended for use in the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or in the determination of the compatibility of human tissues. The Combi Scan 100 fits this definition.
N/A
Intended Use / Indications for Use
The Combi Scan 100 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 100 is a small 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
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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, 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
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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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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Image /page/0/Picture/0 description: The image shows the logo for the company "analyticon". The logo consists of a stylized letter "A" above the company name. The text next to the logo includes the number 351, 51, and 5.
Botechnologics AC
Analyticon Biotechnologies AG
35104 Lichtenfels, Germany
date: 12.05.2006
page 1 of 2
510(k) Submission Combi Scan 100
5. 510(k) Summary
APR - 6 2007
5. 510(k) Summary
| 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. | K061846 | |
| 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 100
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 100 is a small 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
predicative device | The table below shows similarities and differences to the
predicative device | |
| | | |
1
Analyticon Biotechnologies AG
35104 Lichtenfels, Germany
Image /page/1/Picture/2 description: The image shows the logo for analyticon Biotechnologies AG. The logo consists of a large, stylized letter 'A' above the word 'analyticon' in a smaller, sans-serif font. Below 'analyticon' is the text 'Biotechnologies AG' in an even smaller font size. The logo is simple and modern, with a focus on the company name and its association with biotechnology.
510(k) Submission Combi Scan 100 5. 510(k) Summary
| Feature | Combi Scan 100 | 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 500 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, rendered in a simple, bold design.
Public Health Service
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: K061846 Trade/Device Name: Combi Scan 100 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).
3
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.
Jean 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 100
Indications For Use:
The Combi Scan 100 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 Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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