(284 days)
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!
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!
The provided text describes the Combi Scan 500, an automated urine analyzer, and its 510(k) submission. However, it does not include detailed information about acceptance criteria, specific study designs, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or multi-reader multi-case studies. The document primarily focuses on comparisons to a predicate device and regulatory approval.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's the information that can be extracted, with explicit notes for what is not present:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity thresholds) or detailed reported device performance in a quantitative or tabular format. It states the device "measures the color of the light that is reflected from the test pads on the strip... These data are converted into meaningful results." However, it does not quantify what constitutes "meaningful results" or provide performance metrics against such criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide any information regarding the sample size used for any test set or the data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide any information regarding the number or qualifications of experts used to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method.
5. 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
A multi-reader multi-case study was not mentioned or described. The device is an automated urine analyzer, intended to replace or assist in manual reading of test strips, but the document does not focus on human reader performance with or without the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Combi Scan 500 is an automated urine analyzer. Its operation, as described ("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"), indicates it is a standalone device that performs measurements without direct human-in-the-loop interpretation during the measurement process. However, the document does not present a specific "standalone performance study" with metrics. It primarily establishes substantial equivalence to a predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly define the type of ground truth used for any validation studies. Given the nature of a urine analyzer, the ground truth would typically be established by established laboratory methods (e.g., quantitative chemical analysis, microscopic examination of urine sediment, or manual expert reading of the dipsticks by trained personnel). However, this is not stated in the provided text.
8. The sample size for the training set
The document does not provide any information regarding the sample size used for a training set. The Combi Scan 500 is a reflectometric device, and the document doesn't explicitly mention machine learning or AI models requiring "training sets" in the modern sense. It refers to a measurement technology that converts reflected light data into results.
9. How the ground truth for the training set was established
Since no training set is described, how its ground truth was established is not provided.
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L061812
Analyticon Biotechnologies AG
35104 Lichtenfels, Germany
date: 03.04.2006
page 1 of 2
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 followinginformation provides sufficient details to understand the basis fora determination of substantial equivalence | |
|---|---|---|
| 1) 510(k)-Nr. | ||
| 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 500Common 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 500 is a medium automated urine test stripanalyser for use with Combi Screen test strips to determine oneor 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 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 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 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 999 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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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
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.