(101 days)
Bayer Multistix 10SG, Dia Strip System, Calif. Immuno Diagnostics
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No
The device description and intended use clearly state it is a "dip-and-read test strip" with results determined by "visual comparison with a color chart." There is no mention of any computational analysis, image processing, or AI/ML terms.
No.
This device is an in vitro diagnostic aid used for screening for various conditions by analyzing urine specimens; it does not provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is "intended for use as an in vitro diagnostic aid."
No
The device is a physical reagent strip used for urinalysis, requiring a urine specimen and visual comparison to a color chart. It is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the product is intended for use as an in vitro diagnostic aid using urine specimens.
- Device Description: The description confirms it's a "dip-and-read test strip" for testing urine physiological parameters, which is a common format for IVD devices used in urinalysis.
- Purpose: The purpose of the test is to screen for various medical conditions (diabetes, metabolic abnormalities, liver diseases, kidney/urinary tract diseases), which is a diagnostic purpose.
- Specimen Type: It uses a biological specimen (urine) for testing.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Medi-Test Combi 11 is a test strip for rapid determination 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 vitro diagnostic aid using urine specimens for screening for diabetes, metabolic, abnormalities, liver diseases biliary and hepatic obstructions and diseases of the kidneys and the urinary tract.
Product codes (comma separated list FDA assigned to the subject device)
JIL, JIP, CDM, CEN, JIN, JIR, JJB, JMA, JMT, KSL, LJX
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The Macherey-Nagel Combi 11 was investigated in actual clinical use by the Penn Elm Medical Group. The study was conducted during the normal course of providing patient care and included urinalyses for general physical assessment of asymptomatic patients and for patients presenting with specific diagnostic complaints. The study tested 100 randomly-selected urine samples from the clinic's patient population. The Penn Elm study indicates the Combi 11 had very similar results to the Bayer Multistix 10 for the reagent parameters.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing: The Macherey-Nagel Combi 11 was investigated in actual clinical use by the Penn Elm Medical Group. The study was conducted during the normal course of providing patient care and included urinalyses for general physical assessment of asymptomatic patients and for patients presenting with specific diagnostic complaints. The study tested 100 randomly-selected urine samples from the clinic's patient population. The Penn Elm study indicates the Combi 11 had very similar results to the Bayer Multistix 10 for the reagent parameters.
Conclusion: Medi-Test Combi 11 has intended and technological characteristics in common to both predicate devices. A clinical study demonstrated the clinical effectiveness of the added reagent strip areas for screening for leucocytes and specific gravity in urine. Therefore, the Combi 11 is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Bayer Multistix 10SG, Dia Strip System, Calif. Immuno Diagnostics
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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.
1
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 Ellam |
| International Marketing Manager | |
| Macherey-Nagel-Duren | |
| Valencienner Strasse 11 | |
| D-52355 Duren | |
| GERMANY | |
| Date Summary was Prepared | |
| Name Of The Device | Medi-Test Combi 11 |
| Identification Of Predicate | |
| Device(s) | Bayer Multistix 10SG |
| Dia Strip System, Calif. Immuno Diagnostics | |
| Description of The Device | 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 |
| Intended Use | The Medi-Test Combi 11 is a test strip for rapid
determination 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 vitro
diagnostic aid using urine specimens for screening for
diabetes, metabolic, abnormalities, liver diseases
biliary and hepatic obstructions and diseases of the
kidneys and the urinary tract. |
| Comparison of Device
Characteristics to Predicate
Device | The Combi 11 test strip is identical to the Dia Strip
System's nine reagent tests and equivalent in
performance to Bayer's Multistix 10SG. The Combi 11
adds the capability for screening for leucocytes and
specific gravity of urine. |
| SUMMARY OF SAFETY AND EFFECTIVENESS | |
| Non-clinical Testing | Non-clinical testing of the Combi 11 was not
submitted. |
| Clinical Testing | The Macherey-Nagel Combi 11 was investigated in
actual clinical use by the Penn Elm Medical Group.
The study was conducted during the normal course of
providing patient care and included urinalyses for
general physical assessment of asymptomatic patients
and for patients presenting with specific diagnostic
complaints. The study tested 100 randomly-selected
urine samples from the clinic's patient population.
The Penn Elm study indicates the Combi 11 had very
similar results to the Bayer Multistix 10 for the reagent
parameters. |
| Conclusion | Medi-Test Combi 11 has intended and technological
characteristics in common to both predicate devices.
A clinical study demonstrated the clinical
effectiveness of the added reagent strip areas for
screening for leucocytes and specific gravity in urine.
Therefore, the Combi 11 is substantially equivalent to
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.
(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: