Who is the manufacturer of COMBI SCAN100?

Analyticon Biotechnologies AG filed the 510(k) submission for COMBI SCAN100 (K061846).

What is the FDA product code for COMBI SCAN100?

JIL. It is classified under 21 CFR 862.1340 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for COMBI SCAN100?

510(k) clearance (submission type: Traditional).

What are the predicate devices for COMBI SCAN100?

Clinitec 50 (+ Multistix), Bayer (K960546).

Who can help prepare an FDA 510(k) submission like COMBI SCAN100?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

COMBI SCAN100

K061846 · Analyticon Biotechnologies AG · JIL · Apr 6, 2007 · Clinical Chemistry

Device Facts

Record ID	K061846
Device Name	COMBI SCAN100
Applicant	Analyticon Biotechnologies AG
Product Code	JIL · Clinical Chemistry
Decision Date	Apr 6, 2007
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1340
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended 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!

Device Story

Combi Scan 100 is a bench-top automated urine analyzer for professional clinical use. It processes urine-dipped Combi Screen test strips; the user places the strip on a conveyor that moves it into the instrument. The device controls incubation time and performs reflectometric evaluation by measuring light reflected from test pads. Data are converted into clinical results, which are displayed on an LCD and printed via an internal thermal printer. The device stores up to 500 measurements. By automating the reading of urine chemistry, it provides standardized, objective results for diagnosing diabetes, liver, kidney, and metabolic conditions, reducing potential human error associated with visual strip interpretation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Benchtop reflectometric analyzer. Sensing: Color CCD sensor. Energy: Power transformer (100-240V, 50/60Hz). Connectivity: Internal printer, manual/barcode/keyboard input. Software: Automated image processing and data management. Operating range: 15-30°C, <85% humidity.

Indications for Use

Indicated for professional use in clinical settings to evaluate diabetes, liver disease, haemolytic disease, urogenital/kidney disorders, or metabolic abnormalities via urine analysis. Not for self-testing.

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

Clinitec 50 (+ Multistix), Bayer (K960546)

Related Devices

K061812 — COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 · Analyticon Biotechnologies AG · Apr 6, 2007
K060280 — ICHEM 100 URINE CHEMISTRY ANALYZER · Iris International, Inc. · Jun 13, 2006
K111221 — MISSION U500 URINE ANALYZER · ACON Laboratories, Inc. · Jan 18, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ 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 | 7) Statement of substantially equivalence Analyticon has submitted Information that shows the substantial equivalence to the predicative device. {2}------------------------------------------------ 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 {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K061846 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 Page 1 of *_*_ K061846