AIMSTICK URINE REAGENT STRIPS

K051727 · Germaine Laboratories, Inc. · CEN · Oct 26, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051727
• Device Name: AIMSTICK URINE REAGENT STRIPS
• Applicant: Germaine Laboratories, Inc.
• Product Code: CEN · Clinical Chemistry
• Decision Date: Oct 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1550
• Device Class: Class 1

Intended Use

The AimStick® Urine Reagent Strips are intended for detection of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leukocytes in urine.

Device Story

AimStick® Urine Reagent Strips are disposable plastic strips with multiple reagent pads. Used in professional point-of-care settings; operated by clinicians. Input is a urine sample applied to the strip. Principle of operation involves chemical reactions between urine analytes and specific reagents on pads, causing visible color changes. Output is a color change on the strip, which the clinician compares directly to a color chart printed on the product bottle label. No laboratory instrumentation is required. Results assist healthcare providers in assessing patient metabolic, renal, hepatic, and acid-base status, as well as detecting bacteriuria.

Clinical Evidence

Clinical trial comparing AimStick® Urine Reagent Strips to Bayer MultiStix® 10 SG. Study included 196 urine samples tested with both systems. Results demonstrated substantial equivalence between the subject device and the predicate.

Technological Characteristics

Plastic strips with affixed reagent pads. Chemical principles: enzymatic (GOD/POD) for glucose; diazotization for bilirubin, nitrite, and urobilinogen; sodium nitroprusside for ketone; pH indicator/polyelectrolyte for specific gravity and pH; peroxidase-like activity for blood; protein-error-of-indicator for protein; esterase hydrolysis for leukocytes. Visual readout via color comparison. Storage 2-30°C. No electronic components or software.

Indications for Use

Indicated for professional use in the qualitative detection of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes in urine to assess carbohydrate metabolism, kidney/liver function, acid-base balance, and bacterial presence.

Regulatory Classification

Identification

A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.

Predicate Devices

• Roche Chemstrip 10 SG (k896454)

Submission Summary (Full Text)

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K051727

## 510(k) Summary of Safety & Effectiveness

| Device Name: | AimStick® Urine Reagent Strips |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Urinalysis Reagent Strips |
| Device Description: | Plastic strips with reagent pads which provide a color change when<br>exposed to urine. |
| Medical Specialty: | Clinical Chemistry |
| Intended Use: | The AimStick® Urine Reagent Strips are intended for detection of<br>glucose, bilirubin, ketone, specific gravity, blood, pH, protein,<br>urobilinogen, nitrite and leukocytes in urine. |
| Product Description: | The AimStick® Urine Reagent Strips are plastic strips to which<br>Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein,<br>Urobilinogen, Nitrite and Leukocyte reagent pads are affixed. The<br>reagent pads react with the urine and provide a visible color reaction.<br>The product is packaged with a drying agent in a plastic bottle. Each<br>strip is stable and ready to use upon removal from the bottle. The<br>entire reagent strip is disposable. The directions must be followed<br>exactly. Results are obtained by direct comparison of the test strip<br>with the color blocks printed on the bottle label. Laboratory<br>instrumentation is not required. |
| Tests Principles: | |
| Glucose: | This test is based upon the enzymatic glucose oxidase/peroxidase<br>(GOD/POD) method. Glucose oxidase catalyzes the formation of gluconic<br>acid and hydrogen peroxide from the oxidation of glucose. A second<br>enzyme, peroxidase, catalyzes the reaction of hydrogen peroxidase with a<br>potassium iodide chromogen to oxidize the chromogen to colors ranging<br>from green to blue. |
| Bilirubin: | This test is based upon the coupling of bilirubin with diazotized<br>dichloroaniline in a strongly acid medium. The colors produced on the<br>reagent pad ranges through various shades of beige or tan. |
| Ketone: | This test is based upon the reaction between acetoacetate and sodium<br>nitroprusside in an alkaline medium. A positive result is indicated by a color<br>change on the reagent pad from beige to violet. |
| Specific Gravity: | This test is based upon the release of protons in the presence of cations. The<br>reaction produces hydrogenous ionogen, which reacts with pH indicator.<br>Colors produced range from deep blue-green through yellow-green. |
| Blood: | This test is based upon hemoglobin reacting as peroxidase. Intact<br>erythrocytes hemolyze on the test pad and the hemoglobin released produces<br>a green dot. Scattered green dots on the yellow test pad are indicative of<br>intact erythrocytes. A uniform green color is indicative of released<br>hemoglobin, myoglobin, or hemolyzed erythrocytes. The colors produced<br>range from orange through green. |
| pH: | The test is based upon the well known method of pH indicators methyl red<br>and bromthymol blue. The colors range from orange through yellow and<br>green to blue. |
| Protein: | This is based upon the protein-error-of-indicator principle. Anion in the<br>specific pH indicator attracted by cation on protein molecules makes the<br>indicator further ionized, which changes its color. A positive reaction is<br>indicated by a color change from yellow to light green and to darker greens. |

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- Urobilinogen: This test is based on the Ehrlich reaction in which p-diethylamino This "is "is "based" unction with a color enhancer reacts with urobilinogen in a Strongly acid medium. A positive reaction is indicated by a pink-reddish color.
- This test is based upon the conversion of Nitrate to Nitrite. The Nitrite in the Nitrite: rine and aromatic amino sulphanilamide are diazotized to form a diazonium urine aromatio The diazonium compound reacting with tetrahydro benzo(h) quinolin 3-phenol causes the color change. A positive reaction is indicated by a light pink to pink color.
- This test is based upon the reaction of esterases, present in granulocytic Leukocytes: leukocytes, which catalyzc the hydrolysis of an indoxylcarbonic acid ester to indoxyl. A positive reaction is indicated by a light purple to dark purple color.

Characteristics of the AimStick® Urine Reagent Strips are compared with the Bayer MultiStix® 10SG system in the following table:

| Area of Comparison | AimStick® 10-SG | Bayer MultiStix® 10 SG |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Professional use in point-of-care urine testing | Professional use in point-of-care urine testing |
| Target Population | Patients of physicians, hospitals, and clinics | Patients of physicians, hospitals, and clinics |
| Intended Specimen | Urine | Urine |
| Materials Provided | Plastic Strips affixed with several separate reagent areas. | Plastic Strips affixed with several separate reagent areas. |
| Storage | 2 to 30 C | 15 to 30 C |
| Test Time | 30 Seconds - 2 Minutes | 30 Seconds - 2 Minutes |
| Glucose Methodology | Based upon the enzymatic glucose oxidase /peroxidase (GOD/POD) method.<br>Glucose oxidase catalyzes the formation of gluconic acid and hydrogen peroxide from the oxidation of glucose. A second enzyme, peroxidase, catalyzes the reaction of hydrogen peroxidase with a potassium iodide chromogen to oxidize the chromogen to colors ranging from green to blue. | Based on a double sequential enzyme reaction. One enzyme, glucose oxidase, catalyzes the formation of glucuronic acid and hydrogen peroxide from the oxidation of glucose. Peroxidase catalyzes the reaction of hydrogen that cause the color ranges from green to brown. |
| Bilirubin Methodology | Based upon the coupling of bilirubin with diazotized dichloroaniline in a strongly acid medium. The colors | Based on the bilirubin and dichlorobenzene diazonium cupping and produces a strongly acid medium with |
| | produced on the reagent pad<br>ranges through various<br>shades of beige or tan. | colors ranges through shades<br>of tan. |
| Ketone Methodology | Based upon the reaction<br>between acetoacetate and<br>sodium nitroprusside in an<br>alkaline medium. A positive<br>result is indicated by a color<br>change on the reagent pad<br>from beige to violet. | Based on the development of<br>colors ranging from buff-pink<br>for a negative reading, to<br>purple when acetoacetic acid<br>reacts with nitroprusside. |
| Specific Gravity<br>Methodology | Based upon the release of<br>protons in the presence of<br>cations. The reaction<br>produces hydrogenous<br>ionogen, which reacts with<br>pH indicator. Colors<br>produced range from deep<br>blue-green through yellow-<br>green. | Based on the pKa change of<br>polyelectrolytes in relation<br>with ionic concentration. In<br>the presence of an indicator,<br>colors range from deep blue-<br>green through green and<br>yellow-green. |
| Blood Methodology | Based upon hemoglobin<br>reacting as peroxidase. Intact<br>erythrocytes hemolyze on the<br>test pad and the hemoglobin<br>released produces a green<br>dot. Scattered green dots on<br>the yellow test pad are<br>indicative of intact<br>erythrocytes. A uniform<br>green color is indicative of<br>released hemoglobin,<br>myoglobin, or hemolyzed<br>erythrocytes. The colors<br>produced range from orange<br>through green. | Based on the peroxidase-like<br>activity of hemoglobin, which<br>catalyzes the reaction of<br>diisopropylbenzene<br>dihydroperoxide and 3,3',5,5'<br>tetramethylbenzidine. The<br>resulting color ranges from<br>orange through green. |
| pH Methodology | Based upon the well known<br>method of pH indicators<br>methyl red and bromthymol<br>blue. The colors range from<br>orange through yellow and<br>green to blue. | Based on double indicator<br>principle that gives a broad<br>range of colors covering the<br>entire urinary pH range.<br>Colors range from orange<br>through yellow and green to<br>blue. |
| Protein Methodology | Based upon the protein-error-<br>of-indicator principle. Anion<br>in the specific pH indicator<br>attracted by cation on protein<br>molecules makes the<br>indicator further ionized,<br>which changes its color. A<br>positive reaction is indicated<br>by a color change from | Based on the protein-error-of-<br>indicator principle. At a<br>constant pH, the development<br>of any green color due to the<br>presence of protein. Colors<br>range from yellow through<br>yellow-green and green to<br>green-blue. |
| | darker greens. | |
| Urobilinogen<br>Methodology | Based on the Ehrlich reaction<br>in which p-diethylamino<br>benzaldehyde in conjunction<br>with a color enhancer reacts<br>with urobilinogen in a<br>Strongly acid medium. A<br>positive reaction is indicated<br>by a pink-reddish color. | Based on a modified Ehrlich<br>reaction in which p-<br>diethylaminobenzaldehyde in<br>conjunction with a color<br>enhancer reacts with<br>urobilinogen in a strongly<br>acidic medium to produce a<br>pink-red color. |
| Nitrite Methodology | Based upon the conversion of<br>Nitrate to Nitrite. The Nitrite<br>in the urine and aromatic<br>amino sulphanilamide are<br>diazotized to form a<br>diazonium compound. The<br>diazonium compound<br>reacting with tetrahydro<br>benzo(h) quinolin 3-phenol<br>causes the color change. A<br>positive reaction is indicated<br>by a light pink to pink color. | This test depends upon the<br>conversion of nitrate to nitrite<br>by the action of Gram negative<br>bacteria in the urine. The<br>diazonium compound couples<br>with tetrahydrobenzo<br>quiniolin-3ol to produce a pink<br>color. |
| Leukocytes Methodology | Based upon the reaction of<br>esterases, present in<br>granulocytic leukocytes,<br>which catalyze the hydrolysis<br>of an indoxylcarbonic acid<br>ester to indoxyl. A positive<br>reaction is indicated by a<br>light purple to dark purple<br>color. | Granulocyte leukocytes<br>contain esterases that catalyze<br>the hydrolysis of the<br>derivatized pyrrole that react<br>with diazonium salt to produce<br>a purple color. |

## Comparison of Features

The AimStick® Urine Reagent Strips are substantially equivalent Substantial Equivalence: to the Bayer MultiStix® 10SG reagent strips.

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- Summary: A clinical trial was conducted comparing the results of the AimStick® Urine Reagent Strips to the Bayer MultiStix® 10 SG. The study included 196 urine samples that were tested with both AimStick® 10-SG and Bayer MultiStix® 10 SG. The test results were compared. Clinical study results in this 510(k) submission demonstrate that the AimStick® Urine Reagent Strips are substantially equivalent to the Bayer MultiStix® 10 SG.
- Submitted by: Germaine Laboratories, Inc. 4139 Gardendale Center #101 San Antonio, TX 78229
- Prepared on: June 20, 2005 By Martin O'Connor, Regulatory Affairs

- t

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 6 2005

Mr. Martin P. O'Connor General Manager Germaine Laboratories, Inc. 4139 Gardendale Center Suite 101 San Antonio, TX 78229

k051727 Rc:

Trade/Device Name: AimStick® Urine Reagent Strips Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Regulatory Class: Class II
Product Code: JIL, JIO, LJX, CEN, JMT, JIR, JIN, CDM, JJB Dated: September 15, 2005 Received: September 20, 2005

Dear Mr. O'Connor:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed you. Beceeer on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrobare) to togens and the Medical Device Amendments, or to conninered process in accordance with the provisions of the Federal Food, Drug, uc necs mat have been recuire approval of a premarket approval application (PMA). and Costience roo () that the novice, subject to the general controls provisions of the Act. The I ou may, merelove, manov of the Act include requirements for annual registration, listing of general controls provision 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 r lease be actived that i be mination that your device complies with other requirements of the Act that 1171 has made a acterimations administered by other Federal agencies. You must of any I catal studios and regarations, 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 Gitt

- 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 (if known): K051727

Device Name:

AimStick® Urine Reagent Strips

Indications For Use: The AimStick® Urine Reagent Strips are intended for the qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Cravity, Bis in urine for persons to test by visual comparison with a color chart on the bottle label. This product is for professional use. Test results may provide information regarding the status of carbohydrate metabolism, kidney function, liver function, acid-base balance, and bacturia.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Jincy Phillips
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K051727