(101 days)
The Medi-Test Combi 11 Reagent Strip for Urinalysis is a dip-and-read test strip. The product is intended for use as an in vitro diagnostic aid using urine specimens for screening for diabetes, metabolic, abnormalities, liver diseases, biliary and hepatic obstructions and diseases of the kidneys and urinary tract.
The strip provides qualitative and semi-quantitative tests for specific gravity, leucocytes, glucose, protein, blood, nitrite, pH, ketones, bilirubin, ascorbic acid and urobilinogen by visual comparison with a color chart for each concentration range.
The Medi-Test Combi 11 Reagent Strip for urinalysis is a dip-and-read test strip. The Medi-Test Combi 11 provides reagent areas on the strip for testing urine physiological parameters.
The strip provides qualitative and semi-quantitative tests for specific gravity, leucocytes, glucose, ascorbic acid, protein, blood, nitrite, pH, ketones, bilirubin and urobilinogen by visual comparison with a color chart for each concentration range.
Here's an analysis of the provided text to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for K991927, for the Medi-Test Combi 11, focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance acceptance criteria or rigorously quantifying device performance against such. The primary assessment states:
- Acceptance Criteria Implied: Substantially equivalent performance to the predicate devices (Bayer Multistix 10SG and Dia Strip System) for common parameters, and clinical effectiveness for the added parameters (leucocytes and specific gravity).
- Reported Device Performance: The "Penn Elm study indicates the Combi 11 had very similar results to the Bayer Multistix 10 for the reagent parameters." And "A clinical study demonstrated the clinical effectiveness of the added reagent strip areas for screening for leucocytes and specific gravity in urine."
Given this, a formal table of explicit acceptance criteria and corresponding numerical performance metrics is not directly available in the provided text. The evaluation is largely qualitative and comparative.
| Parameter Evaluated | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Reagent Parameters (Common with Predicate) | "Equivalent in performance" to Bayer Multistix 10SG. "Identical" to Dia Strip System's nine reagent tests. | "Very similar results to the Bayer Multistix 10 for the reagent parameters." |
| Leucocytes | "Clinical effectiveness" of added screening capability. | Clinical study "demonstrated the clinical effectiveness of the added reagent strip areas for screening for leucocytes." |
| Specific Gravity | "Clinical effectiveness" of added screening capability. | Clinical study "demonstrated the clinical effectiveness of the added reagent strip areas for screening for... specific gravity in urine." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 100 randomly-selected urine samples.
- Data Provenance: Prospective clinical use study from the Penn Elm Medical Group, USA, conducted during the normal course of providing patient care. Includes asymptomatic patients and those with specific diagnostic complaints.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish ground truth. It states that the study was conducted by the "Penn Elm Medical Group" during "normal course of providing patient care" and included "urinalyses." This suggests the ground truth was likely established by standard laboratory procedures and clinical assessment by the medical group's personnel, but specific expert details are absent.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "Penn Elm study" compares the Combi 11 to the Bayer Multistix 10, implying a direct comparison of results rather than an independent expert adjudication process on the Combi 11's readings.
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
No MRMC study was performed or mentioned. This device is a dip-and-read test strip for visual comparison with a color chart, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was done. This is a visual dip-and-read test strip, not an algorithm-based device.
7. The Type of Ground Truth Used
The ground truth for the comparison was based on results from the predicate device, Bayer Multistix 10, and implied clinical assessment as part of "normal course of providing patient care" for the "clinical effectiveness" demonstration of the added parameters.
8. The Sample Size for the Training Set
The document does not mention a training set. This is a traditional diagnostic test strip, not a machine learning or AI-driven device that typically requires a separate training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB - 4 2005
Macherey-Nagel-Duren c/o Eduardo March, RAC AAC Consulting Group 7361 Calhoun Place Suite 500 Rockville, MD 20855
Re: K991927
Trade/Device Name: Medi-Test Combi 1 1 Regulation Number: 21 CFR§862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: II Product Code: JIL, JIP, CDM, CEN, JIN, JIR, JJB, JMA, JMT, KSL, LJX Dated: August 11, 1999 Received: August 12, 1999
Dear Mr. March:
This letter corrects our substantially equivalent letter of September 17, 1999 regarding missing product codes and primary regulation.
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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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).
This letter will allow you to continue 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) 276-0484. 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 (301) 443 6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, MS, D.V.M.
Jean M. Cooper, MS, 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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Kg91927/51
| SUMMARY OF SAFETY AND EFFECTIVENESS | |
|---|---|
| Submitter: | Bardick EllamInternational Marketing ManagerMacherey-Nagel-DurenValencienner Strasse 11D-52355 DurenGERMANY |
| Date Summary was Prepared | |
| Name Of The Device | Medi-Test Combi 11 |
| Identification Of PredicateDevice(s) | Bayer Multistix 10SGDia Strip System, Calif. Immuno Diagnostics |
| Description of The Device | The Medi-Test Combi 11 Reagent Strip for urinalysisis a dip-and-read test strip. The Medi-Test Combi 11provides reagent areas on the strip for testing urinephysiological parameters.The strip provides qualitative and semi-quantitativetests for specific gravity, leucocytes, glucose, ascorbicacid, protein, blood, nitrite, pH, ketones, bilirubin andurobilinogen by visual comparison with a color chartfor each concentration range |
| Intended Use | The Medi-Test Combi 11 is a test strip for rapiddetermination of blood, urobilinogen, bilirubin,protein, nitrite, ketones, ascorbic acid, glucose, pH,specific gravity and leucocytes in urine.The product is intended for use as an in vitrodiagnostic aid using urine specimens for screening fordiabetes, metabolic, abnormalities, liver diseasesbiliary and hepatic obstructions and diseases of thekidneys and the urinary tract. |
| Comparison of DeviceCharacteristics to PredicateDevice | The Combi 11 test strip is identical to the Dia StripSystem's nine reagent tests and equivalent inperformance to Bayer's Multistix 10SG. The Combi 11adds the capability for screening for leucocytes andspecific gravity of urine. |
| SUMMARY OF SAFETY AND EFFECTIVENESS | |
| Non-clinical Testing | Non-clinical testing of the Combi 11 was notsubmitted. |
| Clinical Testing | The Macherey-Nagel Combi 11 was investigated inactual clinical use by the Penn Elm Medical Group.The study was conducted during the normal course ofproviding patient care and included urinalyses forgeneral physical assessment of asymptomatic patientsand for patients presenting with specific diagnosticcomplaints. The study tested 100 randomly-selectedurine samples from the clinic's patient population.The Penn Elm study indicates the Combi 11 had verysimilar results to the Bayer Multistix 10 for the reagentparameters. |
| Conclusion | Medi-Test Combi 11 has intended and technologicalcharacteristics in common to both predicate devices.A clinical study demonstrated the clinicaleffectiveness of the added reagent strip areas forscreening for leucocytes and specific gravity in urine.Therefore, the Combi 11 is substantially equivalent tothe predicate devices. |
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DRAFT
June 4, 1999
K 991927 510(k) Number (if known):
Medi-Test Combi 11 Device Name:
Indications for Use:
The Medi-Test Combi 11 Reagent Strip for Urinalysis is a dip-and-read test strip. The product is intended for use as an in vitro diagnostic aid using urine specimens for screening for diabetes, metabolic, abnormalities, liver diseases, biliary and hepatic obstructions and diseases of the kidneys and urinary tract.
The strip provides qualitative and semi-quantitative tests for specific gravity, leucocytes, glucose, protein, blood, nitrite, pH, ketones, bilirubin, ascorbic acid and urobilinogen by visual comparison with a color chart for each concentration range.
Dean Cooper
(Division Sign-Off)
Division of Clinical Lab
vicos
510(k) Number K991927.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (Per 21 CFR 80.109) OR
Over-the-Counter Use:
§ 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.