URITEST 10 URINALYSIS REAGENT STRIPS

K052719 · Arj Medical, Inc. · CDM · Dec 5, 2006 · Clinical Chemistry

Device Facts

• Record ID: K052719
• Device Name: URITEST 10 URINALYSIS REAGENT STRIPS
• Applicant: Arj Medical, Inc.
• Product Code: CDM · Clinical Chemistry
• Decision Date: Dec 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1785
• Device Class: Class 1

Intended Use

URITEST 10 Urinalysis Reagent Strips provide qualitative and semi-quantitative tests for glucose, bilirubin, ketones (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrites, and leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriuria. ARJ Medical URITEST 10 Urinalysis Reagent Strips are for single use in professional near patient (point-of-care) facilities and centralized laboratory locations by medical technologists both read visually and on the Bayer Family of Clinitek Analyzers. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas: Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration

Device Story

URITEST 10 Urinalysis Reagent Strips are firm plastic, dry reagent strips for urinalysis. Input: fresh, well-mixed, uncentrifuged urine sample. Operation: reagent areas dipped into urine; colorimetric reaction occurs. Output: visual color change read against chart or instrumental reading via Bayer Clinitek Urine Analyzers. Results available within 120 seconds. Used in professional POC facilities and centralized labs by medical technologists. Output assists in screening for kidney/liver function, UTI, carbohydrate metabolism, acid-base balance, and urine concentration; helps determine if microscopic analysis is required. Benefits patient by providing rapid diagnostic screening information.

Clinical Evidence

No clinical trials were performed. Substantial equivalence was established via analytical bench testing and method comparison studies. Precision was evaluated using commercial controls (10 measurements/level, 2x/day, 10 days). Linearity and detection limits were validated using spiked urine samples (n=60 per concentration). Method comparison involved 1,514 clinical samples measured in duplicate across five platforms (visual and four Clinitek analyzer models), showing high agreement with the predicate device.

Technological Characteristics

Firm plastic, dry reagent strips. 10-parameter test format (glucose, bilirubin, ketones, specific gravity, blood, pH, protein, urobilinogen, nitrites, leukocytes). Compatible with Bayer Clinitek Urine Analyzers for instrumental reading. Visual reading via color chart. Single-use.

Indications for Use

Indicated for professional use in point-of-care and centralized lab settings to screen at-risk patients for kidney function, urinary tract infections, carbohydrate metabolism, liver function, acid-base balance, and urine concentration. Provides qualitative/semi-quantitative results for glucose, bilirubin, ketones, specific gravity, blood, pH, protein, urobilinogen, nitrites, and leukocytes.

Regulatory Classification

Identification

A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders.

Predicate Devices

• Bayer Corporation MULTISTIX 10 SG Regent Strip (k852611)

Submission Summary (Full Text)

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# URITEST 10 510(K) Summary

K052719

| Prepared: | November 1, 2006 | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter: | ARJ Medical, Inc | |
| Address: | 209 State Street<br>Oldsmar, FL 34677 | DEC - 5 2006 |
| Contact Person: | Aaron Behar<br>ARJ Medical, Inc<br>209 State Street<br>Oldsmar, FL 34677<br>Tel: [phone]<br>Fax: [phone] | |
| Trade Proprietary Name: | URITEST 10 Urinalysis Reagent Strips | |
| Common/Usual Name: | Urinalysis Test Strips | |

#### Classification Names:

Urinary glucose (non-quantitative) test system (21 CFR 862.1340) - Class 11 Urinary bilirubin and its conjugates (non-quantitative) test system (21 CFR 862.1115) - Class I Ketones (non-quantitative) test system (21 CFR 862.1435) - Class I Specific Gravity test (not classified in 21 CFR 862 or 864) - proposed Class I Occult blood test (21 CFR 864.6550) - Class II Urinary pH (non-quantitative) test system (21 CFR 862.1550) - Class I Urinary protein or albumin (non-quantitative) test system (21 CFR 862.1645) -Class I Urinary urobilinogen (non-quantitative) test system (21 CFR 862.1785) - Class I Nitrite (non-quantitative) test system (21 CFR 862.1510) - Class I Leukocyte peroxidase test (21 CFR 864.7675) - Class I

### Legally marketed devices which we are claiming equivalence:

Bayer Corporation MULTISTIX 10 SG Reagent Strips

#### Device Description:

URITEST 10 Urinalysis Reagent Strips provide qualitative and semi-quantitative for pH, specific gravity, ketones. blood, protein, nitrite, leukocytes, glucose, bilirubin, and urobilinogen in urine. URITEST 10 Urinalysis Reagent Strips are firm plastic, dry reagent strips. The reagent areas are dipped into the urine sample and read visually according to a color chart or are read instrumentally with a Bayer® Family of Clinitek Urine Analyzers. The results are available within 120 seconds. To obtain optimal results, it is necessary to use fresh, well-mixed and uncentrifuged urine.

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#### Intended Use:

ARJ Medical URITEST 10 Urinalysis Reagent Strips are for single use in professional near patient (pointof-care) facilities and centralized laboratory locations by medical technologists both read visually and on the Bayer Family of Clinitek Analyzers. .

#### Assessment of Performance:

The performance of URITEST 10 Urinalysis Reagent Strips was studied in a clinical laboratory setting. The strips were read visually and instrumentally using the Family of Bayer Clinitek Urine Analyzers. The results were compared to results obtained from Bayer MULTISTIX 10 SG reagent strips. The studies demonstrated that professional users in centralized and point-of-care (POC) hospital . clinical and doctor's office setting can obtain valid urinalysis test results.

#### Conclusion:

URITEST 10 Urinalysis Reagent Strips provide 10 reagent tests of urinalysis that are similar in composition and performance to reagent tests currently provided by devices on the U.S. market. URITEST 10 Urinalysis Reagent Strips are suitable for use in point-of-care (POC) settings. ARJ Medical studies showed that URITEST 10 Urinalysis Reagent Strips provide test results consistent with laboratory methods and performance comparable to that of Bayer MULTISTIX 10 SG Reagent Strips in POC, hospital, and clinical settings.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three wavy lines representing the three branches of government. The logo is surrounded by the words "U.S. Department of Health & Human Services" in a circular pattern.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Aaron Behar ARJ Medical, Inc. 209 State Street Oldsmar, FL 34677

DEC - 5 2006

Re: k052719

Trade/Device Name: URITEST 10 Urinalysis Reagent Strips Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: JIO, JIL, CDM, JJB, JIN, JIR, JMT, LJX, CEN Dated: November 1, 2006 Received: November 3, 2006

Dear Mr. Behar:

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 [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,

Alberto Guts

Alberto Gutierrez, Ph.D. 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: (Applied For)

Device Name: URITEST 10 Urinalysis Reagent Strips

Indications for Use:

URITEST 10 Urinalysis Reagent Strips provide qualitative and sem-quantitative tests for glucose, bilirubin, ketones (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrites, and leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriuria.

ARJ Medical URITEST 10 Urinalysis Reagent Strips are for single use in professional near patient (point-of-care) facilities and centralized laboratory locations by medical technologists both read visually and on the Bayer Family of Clinitek Analyzers. The strips are intended of use in screening at-risk patients to assist diagnosis in the following areas:

Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration

Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.

Prescription Use __ X___ AND/OR Over-The-Counter Use _____________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 807 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 Benem

Office of In Vitro Diagnostic Device Evaluation and Safety

K052719