(120 days)
The AimStick® Urine Reagent Strips are intended for detection of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leukocytes in urine.
The AimStick® Urine Reagent Strips are intended for the qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes 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.
Plastic strips with reagent pads which provide a color change when exposed to urine.
The AimStick® Urine Reagent Strips are plastic strips to which Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocyte reagent pads are affixed. The reagent pads react with the urine and provide a visible color reaction. The product is packaged with a drying agent in a plastic bottle. Each strip is stable and ready to use upon removal from the bottle. The entire reagent strip is disposable. The directions must be followed exactly. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. Laboratory instrumentation is not required.
Here's a breakdown of the acceptance criteria and study information for the AimStick® Urine Reagent Strips, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria in terms of sensitivity, specificity, or agreement percentages. Instead, the acceptance criterion is implied as "substantial equivalence" to the predicate device (Bayer MultiStix® 10SG). The reported device performance is described as meeting this criterion through a comparative clinical trial.
| Analyte (Test Parameter) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Glucose | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| Bilirubin | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| Ketone | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| Specific Gravity | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| Blood | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| pH | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| Protein | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| Urobilinogen | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| Nitrite | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
| Leukocytes | Substantially equivalent to Bayer MultiStix® 10SG | Clinical study results demonstrate substantial equivalence to Bayer MultiStix® 10SG. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 196 urine samples.
- Data Provenance: The text does not explicitly state the country of origin. It describes the study as a "clinical trial" comparing two devices, which implies prospective data collection for the purpose of the study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The text does not provide information on the number of experts used or their qualifications for establishing ground truth. The study design described is a direct comparison between the AimStick® and the predicate device (Bayer MultiStix® 10SG), implying the predicate device's results served as the reference for comparison, rather than an independent expert-adjudicated ground truth.
4. Adjudication Method for the Test Set
The text does not describe an adjudication method. The study design directly compares the results of the AimStick® with the Bayer MultiStix® 10SG. This suggests a direct comparison method rather than an independent adjudication for establishing truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a visually read diagnostic strip (without AI) and the study described is a direct comparison between two test strip products.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) study was not done. This device is a manual, visually interpreted test strip, not an algorithm-based or AI-driven system. The "performance" is based on human visual interpretation of the color changes on the strip.
7. The Type of Ground Truth Used
The ground truth for the comparison was essentially the results obtained from the legally marketed predicate device, Bayer MultiStix® 10SG. The study aimed to demonstrate that the AimStick® results align with those of the established predicate device.
8. The Sample Size for the Training Set
The text does not mention a training set because this is a diagnostic device that relies on chemical reactions and visual interpretation, not an AI or machine learning model that would require a separate training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set mentioned or implied for this type of device.
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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 whenexposed to urine. |
| Medical Specialty: | Clinical Chemistry |
| Intended Use: | The AimStick® Urine Reagent Strips are intended for detection ofglucose, bilirubin, ketone, specific gravity, blood, pH, protein,urobilinogen, nitrite and leukocytes in urine. |
| Product Description: | The AimStick® Urine Reagent Strips are plastic strips to whichGlucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein,Urobilinogen, Nitrite and Leukocyte reagent pads are affixed. Thereagent pads react with the urine and provide a visible color reaction.The product is packaged with a drying agent in a plastic bottle. Eachstrip is stable and ready to use upon removal from the bottle. Theentire reagent strip is disposable. The directions must be followedexactly. Results are obtained by direct comparison of the test stripwith the color blocks printed on the bottle label. Laboratoryinstrumentation is not required. |
| Tests Principles: | |
| Glucose: | This test is based upon the enzymatic glucose oxidase/peroxidase(GOD/POD) method. Glucose oxidase catalyzes the formation of gluconicacid and hydrogen peroxide from the oxidation of glucose. A secondenzyme, peroxidase, catalyzes the reaction of hydrogen peroxidase with apotassium iodide chromogen to oxidize the chromogen to colors rangingfrom green to blue. |
| Bilirubin: | This test is based upon the coupling of bilirubin with diazotizeddichloroaniline in a strongly acid medium. The colors produced on thereagent pad ranges through various shades of beige or tan. |
| Ketone: | This test is based upon the reaction between acetoacetate and sodiumnitroprusside in an alkaline medium. A positive result is indicated by a colorchange on the reagent pad from beige to violet. |
| Specific Gravity: | This test is based upon the release of protons in the presence of cations. Thereaction produces hydrogenous ionogen, which reacts with pH indicator.Colors produced range from deep blue-green through yellow-green. |
| Blood: | This test is based upon hemoglobin reacting as peroxidase. Intacterythrocytes hemolyze on the test pad and the hemoglobin released producesa green dot. Scattered green dots on the yellow test pad are indicative ofintact erythrocytes. A uniform green color is indicative of releasedhemoglobin, myoglobin, or hemolyzed erythrocytes. The colors producedrange from orange through green. |
| pH: | The test is based upon the well known method of pH indicators methyl redand bromthymol blue. The colors range from orange through yellow andgreen to blue. |
| Protein: | This is based upon the protein-error-of-indicator principle. Anion in thespecific pH indicator attracted by cation on protein molecules makes theindicator further ionized, which changes its color. A positive reaction isindicated 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.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 padranges through variousshades of beige or tan. | colors ranges through shadesof tan. | |
| Ketone Methodology | Based upon the reactionbetween acetoacetate andsodium nitroprusside in analkaline medium. A positiveresult is indicated by a colorchange on the reagent padfrom beige to violet. | Based on the development ofcolors ranging from buff-pinkfor a negative reading, topurple when acetoacetic acidreacts with nitroprusside. |
| Specific GravityMethodology | Based upon the release ofprotons in the presence ofcations. The reactionproduces hydrogenousionogen, which reacts withpH indicator. Colorsproduced range from deepblue-green through yellow-green. | Based on the pKa change ofpolyelectrolytes in relationwith ionic concentration. Inthe presence of an indicator,colors range from deep blue-green through green andyellow-green. |
| Blood Methodology | Based upon hemoglobinreacting as peroxidase. Intacterythrocytes hemolyze on thetest pad and the hemoglobinreleased produces a greendot. Scattered green dots onthe yellow test pad areindicative of intacterythrocytes. A uniformgreen color is indicative ofreleased hemoglobin,myoglobin, or hemolyzederythrocytes. The colorsproduced range from orangethrough green. | Based on the peroxidase-likeactivity of hemoglobin, whichcatalyzes the reaction ofdiisopropylbenzenedihydroperoxide and 3,3',5,5'tetramethylbenzidine. Theresulting color ranges fromorange through green. |
| pH Methodology | Based upon the well knownmethod of pH indicatorsmethyl red and bromthymolblue. The colors range fromorange through yellow andgreen to blue. | Based on double indicatorprinciple that gives a broadrange of colors covering theentire urinary pH range.Colors range from orangethrough yellow and green toblue. |
| Protein Methodology | Based upon the protein-error-of-indicator principle. Anionin the specific pH indicatorattracted by cation on proteinmolecules makes theindicator further ionized,which changes its color. Apositive reaction is indicatedby a color change from | Based on the protein-error-of-indicator principle. At aconstant pH, the developmentof any green color due to thepresence of protein. Colorsrange from yellow throughyellow-green and green togreen-blue. |
| darker greens. | ||
| UrobilinogenMethodology | Based on the Ehrlich reactionin which p-diethylaminobenzaldehyde in conjunctionwith a color enhancer reactswith urobilinogen in aStrongly acid medium. Apositive reaction is indicatedby a pink-reddish color. | Based on a modified Ehrlichreaction in which p-diethylaminobenzaldehyde inconjunction with a colorenhancer reacts withurobilinogen in a stronglyacidic medium to produce apink-red color. |
| Nitrite Methodology | Based upon the conversion ofNitrate to Nitrite. The Nitritein the urine and aromaticamino sulphanilamide arediazotized to form adiazonium compound. Thediazonium compoundreacting with tetrahydrobenzo(h) quinolin 3-phenolcauses the color change. Apositive reaction is indicatedby a light pink to pink color. | This test depends upon theconversion of nitrate to nitriteby the action of Gram negativebacteria in the urine. Thediazonium compound coupleswith tetrahydrobenzoquiniolin-3ol to produce a pinkcolor. |
| Leukocytes Methodology | Based upon the reaction ofesterases, present ingranulocytic leukocytes,which catalyze the hydrolysisof an indoxylcarbonic acidester to indoxyl. A positivereaction is indicated by alight purple to dark purplecolor. | Granulocyte leukocytescontain esterases that catalyzethe hydrolysis of thederivatized pyrrole that reactwith diazonium salt to producea 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.
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Submitted by: Germaine Laboratories, Inc. 4139 Gardendale Center #101 San Antonio, TX 78229
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Prepared on: June 20, 2005 By Martin O'Connor, Regulatory Affairs
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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 (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,
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
Page 1 of 1
510(k) K051727
§ 862.1550 Urinary pH (nonquantitative) test system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.