MEDI-TEST COMBI 11

K991927 · Macherey-Nagel-Duren · JIL · Sep 17, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991927
• Device Name: MEDI-TEST COMBI 11
• Applicant: Macherey-Nagel-Duren
• Product Code: JIL · Clinical Chemistry
• Decision Date: Sep 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Intended 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.

Device Story

Medi-Test Combi 11 is a dip-and-read reagent strip for urinalysis. Device features multiple reagent areas on a single strip to test for specific gravity, leucocytes, glucose, ascorbic acid, protein, blood, nitrite, pH, ketones, bilirubin, and urobilinogen. Operation involves dipping the strip into a urine specimen and visually comparing color changes on the strip against a provided color chart to obtain qualitative or semi-quantitative results. Used in clinical settings by healthcare providers during routine physical assessments or diagnostic evaluations. Output assists clinicians in screening for metabolic, hepatic, biliary, and renal conditions. Benefits include rapid, point-of-care screening for multiple physiological parameters from a single urine sample.

Clinical Evidence

Clinical study conducted by Penn Elm Medical Group on 100 randomly-selected urine samples from a general patient population. Study compared Combi 11 results against Bayer Multistix 10 for reagent parameters during routine physical assessments and diagnostic evaluations. Results indicated similar performance between the subject device and the predicate.

Technological Characteristics

Dip-and-read reagent strip for urinalysis. Employs colorimetric chemical reaction principle for analyte detection. Provides qualitative and semi-quantitative results via visual comparison to a color chart. No electronic components, software, or energy source required.

Indications for Use

Indicated for use as an in vitro diagnostic aid for screening urine specimens for diabetes, metabolic abnormalities, liver diseases, biliary and hepatic obstructions, and diseases of the kidneys and urinary tract in patients undergoing general physical assessment or presenting with diagnostic complaints.

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

• Bayer Multistix 10SG
• Dia Strip System, Calif. Immuno Diagnostics

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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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| SUMMARY OF SAFETY AND EFFECTIVENESS | |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Bardick Ellam<br>International Marketing Manager<br>Macherey-Nagel-Duren<br>Valencienner Strasse 11<br>D-52355 Duren<br>GERMANY |
| Date Summary was Prepared | |
| Name Of The Device | Medi-Test Combi 11 |
| Identification Of Predicate<br>Device(s) | Bayer Multistix 10SG<br>Dia Strip System, Calif. Immuno Diagnostics |
| Description of The Device | The Medi-Test Combi 11 Reagent Strip for urinalysis<br>is a dip-and-read test strip. The Medi-Test Combi 11<br>provides reagent areas on the strip for testing urine<br>physiological parameters.<br><br>The strip provides qualitative and semi-quantitative<br>tests for specific gravity, leucocytes, glucose, ascorbic<br>acid, protein, blood, nitrite, pH, ketones, bilirubin and<br>urobilinogen by visual comparison with a color chart<br>for each concentration range |
| Intended Use | The Medi-Test Combi 11 is a test strip for rapid<br>determination of blood, urobilinogen, bilirubin,<br>protein, nitrite, ketones, ascorbic acid, glucose, pH,<br>specific gravity and leucocytes in urine.<br><br>The product is intended for use as an in vitro<br>diagnostic aid using urine specimens for screening for<br>diabetes, metabolic, abnormalities, liver diseases<br>biliary and hepatic obstructions and diseases of the<br>kidneys and the urinary tract. |
| Comparison of Device<br>Characteristics to Predicate<br>Device | The Combi 11 test strip is identical to the Dia Strip<br>System's nine reagent tests and equivalent in<br>performance to Bayer's Multistix 10SG. The Combi 11<br>adds the capability for screening for leucocytes and<br>specific gravity of urine. |
| SUMMARY OF SAFETY AND EFFECTIVENESS | |
| Non-clinical Testing | Non-clinical testing of the Combi 11 was not<br>submitted. |
| Clinical Testing | The Macherey-Nagel Combi 11 was investigated in<br>actual clinical use by the Penn Elm Medical Group.<br>The study was conducted during the normal course of<br>providing patient care and included urinalyses for<br>general physical assessment of asymptomatic patients<br>and for patients presenting with specific diagnostic<br>complaints. The study tested 100 randomly-selected<br>urine samples from the clinic's patient population.<br>The Penn Elm study indicates the Combi 11 had very<br>similar results to the Bayer Multistix 10 for the reagent<br>parameters. |
| Conclusion | Medi-Test Combi 11 has intended and technological<br>characteristics in common to both predicate devices.<br>A clinical study demonstrated the clinical<br>effectiveness of the added reagent strip areas for<br>screening for leucocytes and specific gravity in urine.<br>Therefore, the Combi 11 is substantially equivalent to<br>the 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 80.109) OR

Over-the-Counter Use: