(284 days)
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!
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!
The provided documentation describes the Combi Scan 100, an automated urine analyzer, and its 510(k) submission for substantial equivalence to a predicate device, the Clinitek 50. However, the document does not contain specific acceptance criteria, a detailed study report demonstrating performance against such criteria, or the methodology used for establishing ground truth or expert adjudication.
The document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria.
-
Table of Acceptance Criteria and Reported Device Performance:
This information is not available in the provided text. The document states that "Analyticon has submitted Information that shows the substantial equivalence to the predicative device," but it does not detail the specific performance metrics or acceptance criteria used to establish this equivalence, nor does it present the Combi Scan 100's performance against them in a table. -
Sample size used for the test set and the data provenance:
This information is not available in the provided text. The submission summary does not include details on the sample size used for any testing or the provenance of the data (e.g., country of origin, retrospective/prospective). -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available in the provided text. There is no mention of expert involvement in establishing ground truth for any test sets. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not available in the provided text. No adjudication method is described. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable/not available. The Combi Scan 100 is described as an "Automated Urine Analyzer" that measures urine test strips. It does not appear to be an AI-assisted device designed to improve human reader performance in a diagnostic setting. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers would not be relevant to this device as described. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not explicitly detailed, but the nature of the device suggests standalone performance: "The instrument measures the color of the light that is reflected from the test pads on the strip... These data are converted into meaningful results." This implies the device provides direct results without human interpretation of the color changes. Comparison is made to another automated analyzer, the Clinitek 50. The summary itself is focused on device properties and functional equivalence rather than detailed performance studies. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not available in the provided text. The document does not specify how the ground truth for any performance evaluation was established. For urine analyzers, ground truth typically involves reference laboratory methods or established manual interpretations of test strips. -
The sample size for the training set:
This information is not available in the provided text. There is no mention of a "training set" or its size, as this type of device (an automated urine analyzer) typically relies on predefined optical or chemical reaction parameters rather than a machine learning training paradigm. -
How the ground truth for the training set was established:
This information is not applicable/not available for the reasons stated above (no mention of a training set or machine learning).
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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 followinginformation provides sufficient details to understand the basis fora determination of substantial equivalence | |
|---|---|---|
| 1) 510(k)-Nr. | K061846 | |
| 2) Submitter | Analyticon Biotechnologies AGAm Mühlenberg 1035104 LichtenfelsGermanyPhone +49-6454-7991-0FAX: +49-6454-7991-30e-mail: info@analyticon.dewww.analyticon.deContact Person: Dr. Klaus LangerRepresentative in USA:Kamm & Associates333 Milford Road, 60015 Deerfield, IL | |
| 2) Device Name | Proprietary Name: Combi Scan 100Common Name: Automated Urine AnalyzerClassification 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.) testsystem (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 usewith Combi Screen test strips to determine one or more of thefollowing 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 Screenfor in-vitro determination of Ascorbic acid, Bilirubin, Blood,Glucose, Ketones, Leukocytes, Nitrite, pH, Protein, SpecificGravity, and Urobilinogen from urine.For professional use, not for self testing. | |
| 6) Comparison topredicative device | The table below shows similarities and differences to thepredicative device | |
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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 stripsCombi Screen for in-vitro determination ofAscorbic 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 foruse with Bayer reagent strips for thedetermination of glucose, bilirubin, ketone,blood, protein, urobilinogen, nitrite andleucocytes in urine, urine pH, specific gravityand colour. The tests on Bayer Reagent stripsand urine color are considered routineurinalysis. |
| General design | Bench-top instrument | Bench-top instrument |
| Energy source | Power transformerInput: 100 - 240 V, 50/60 HzOutput. 7,5V, 3,0 A | Power transformerInput: 100 - 250 V, 50/60 HzOutput. 9V, 2,78 A |
| Measurementtechnology | The instrument measures the color of the lightthat is reflected from the test pads on the strip(reflectometric evauation). These data areconverted into meaningful results. | The instrument measures the color andamount of light that is reflected from the testpads on the strip (reflectometricmeasurement). It then converts thesemeasurements to meaningful results. |
| Measuringoperation | The test strip is dipped into the urine andplaced on a conveyor, which moves the stripinto the instrument. The instrument controls theincubation time and does the measurement. | The test strip is dipped into the urine andplaced on the strip holder in front of theinstrument. Then, the strip holder is moved intothe instrument, which controls the incubationtime 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, SpecificGravity, and Urobilinogen from urine. |
| Controlling ofthe system | LCD-Display, buttons below the display tocontrol the instrument. | LCD-Display, buttons below the display tocontrol the instrument. |
| Storage ofresults | Storage of 500 measurements possible | Storage of measurements possible |
| Printing ofresults | Printout with results, date & time on thermalpaper by internal printer | Printout with results, date & time on thermalpaper 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).
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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.
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
Page 1 of __
§ 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.