K Number
K051727
Device Name
AIMSTICK URINE REAGENT STRIPS
Date Cleared
2005-10-26

(120 days)

Regulation Number
862.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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. 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.
Device Description
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.
More Information

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No
The device description and intended use clearly state that results are obtained by visual comparison with a color chart, and no instrumentation or software is mentioned.

No
The device is for diagnostic purposes, specifically for detecting various substances in urine, which provides information for diagnosis rather than directly treating a condition.

Yes

The device detects specific analytes in urine (e.g., glucose, bilirubin, protein) which provides information regarding the status of various bodily functions (carbohydrate metabolism, kidney function, liver function), thus aiding in the identification or monitoring of medical conditions.

No

The device description explicitly states it is a "Plastic strips with reagent pads" and describes a physical product that reacts with urine and provides a visible color reaction. It is a hardware-based diagnostic test.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states that the device is for the "detection of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leukocytes in urine." This involves testing a biological sample (urine) outside of the body to gain information about a person's health status.
  • Device Description: The device is a "plastic strip with reagent pads which provide a color change when exposed to urine." This describes a test that is performed in vitro (in glass or outside the body) using chemical reagents.
  • Professional Use: While it mentions professional use, the core function is the analysis of a biological sample in vitro.
  • Comparison to Predicate: The comparison to the Bayer MultiStix® 10 SG, which is a known IVD, further supports its classification as an IVD.

The definition of an IVD generally includes devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease. The AimStick® Urine Reagent Strips clearly fit this description.

N/A

Intended Use / Indications for 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

JIL, JIO, LJX, CEN, JMT, JIR, JIN, CDM, JJB

Device Description

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.

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

Professional use in point-of-care urine testing
Patients of physicians, hospitals, and clinics

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

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

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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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§ 862.1550 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.

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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
exposed to urine.
Medical Specialty:Clinical Chemistry
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.
Product Description: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.
Tests Principles:
Glucose:This test is 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.
Bilirubin:This test is based upon the coupling of bilirubin with diazotized
dichloroaniline in a strongly acid medium. The colors produced on the
reagent pad ranges through various shades of beige or tan.
Ketone:This test is based upon the reaction between acetoacetate and sodium
nitroprusside in an alkaline medium. A positive result is indicated by a color
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
reaction 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. Intact
erythrocytes hemolyze on the test pad and the hemoglobin released produces
a green dot. Scattered green dots on the yellow test pad are indicative of
intact erythrocytes. A uniform green color is indicative of released
hemoglobin, myoglobin, or hemolyzed erythrocytes. The colors produced
range from orange through green.
pH:The test is based upon the well known method of pH indicators methyl red
and bromthymol blue. The colors range from orange through yellow and
green to blue.
Protein:This is based upon the protein-error-of-indicator principle. Anion in the
specific pH indicator attracted by cation on protein molecules makes the
indicator further ionized, which changes its color. A positive reaction is
indicated by a color change from yellow to light green and to darker greens.

1

  • 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 ComparisonAimStick® 10-SGBayer MultiStix® 10 SG
Intended UseProfessional use in point-of-care urine testingProfessional use in point-of-care urine testing
Target PopulationPatients of physicians, hospitals, and clinicsPatients of physicians, hospitals, and clinics
Intended SpecimenUrineUrine
Materials ProvidedPlastic Strips affixed with several separate reagent areas.Plastic Strips affixed with several separate reagent areas.
Storage2 to 30 C15 to 30 C
Test Time30 Seconds - 2 Minutes30 Seconds - 2 Minutes
Glucose MethodologyBased 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 MethodologyBased upon the coupling of bilirubin with diazotized dichloroaniline in a strongly acid medium. The colorsBased on the bilirubin and dichlorobenzene diazonium cupping and produces a strongly acid medium with
produced on the reagent pad
ranges through various
shades of beige or tan.colors ranges through shades
of tan.
Ketone MethodologyBased upon the reaction
between acetoacetate and
sodium nitroprusside in an
alkaline medium. A positive
result is indicated by a color
change on the reagent pad
from beige to violet.Based on the development of
colors ranging from buff-pink
for a negative reading, to
purple when acetoacetic acid
reacts with nitroprusside.
Specific Gravity
MethodologyBased upon the release of
protons in the presence of
cations. The reaction
produces hydrogenous
ionogen, which reacts with
pH indicator. Colors
produced range from deep
blue-green through yellow-
green.Based on the pKa change of
polyelectrolytes in relation
with ionic concentration. In
the presence of an indicator,
colors range from deep blue-
green through green and
yellow-green.
Blood MethodologyBased upon hemoglobin
reacting as peroxidase. Intact
erythrocytes hemolyze on the
test pad and the hemoglobin
released produces a green
dot. Scattered green dots on
the yellow test pad are
indicative of intact
erythrocytes. A uniform
green color is indicative of
released hemoglobin,
myoglobin, or hemolyzed
erythrocytes. The colors
produced range from orange
through green.Based on the peroxidase-like
activity of hemoglobin, which
catalyzes the reaction of
diisopropylbenzene
dihydroperoxide and 3,3',5,5'
tetramethylbenzidine. The
resulting color ranges from
orange through green.
pH MethodologyBased upon the well known
method of pH indicators
methyl red and bromthymol
blue. The colors range from
orange through yellow and
green to blue.Based on double indicator
principle that gives a broad
range of colors covering the
entire urinary pH range.
Colors range from orange
through yellow and green to
blue.
Protein MethodologyBased upon the protein-error-
of-indicator principle. Anion
in the specific pH indicator
attracted by cation on protein
molecules makes the
indicator further ionized,
which changes its color. A
positive reaction is indicated
by a color change fromBased on the protein-error-of-
indicator principle. At a
constant pH, the development
of any green color due to the
presence of protein. Colors
range from yellow through
yellow-green and green to
green-blue.
darker greens.
Urobilinogen
MethodologyBased on the Ehrlich reaction
in which p-diethylamino
benzaldehyde in conjunction
with a color enhancer reacts
with urobilinogen in a
Strongly acid medium. A
positive reaction is indicated
by a pink-reddish color.Based on a modified Ehrlich
reaction in which p-
diethylaminobenzaldehyde in
conjunction with a color
enhancer reacts with
urobilinogen in a strongly
acidic medium to produce a
pink-red color.
Nitrite MethodologyBased upon the conversion of
Nitrate to Nitrite. The Nitrite
in the urine and aromatic
amino sulphanilamide are
diazotized to form a
diazonium compound. 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 depends upon the
conversion of nitrate to nitrite
by the action of Gram negative
bacteria in the urine. The
diazonium compound couples
with tetrahydrobenzo
quiniolin-3ol to produce a pink
color.
Leukocytes MethodologyBased upon the reaction of
esterases, present in
granulocytic leukocytes,
which catalyze the hydrolysis
of an indoxylcarbonic acid
ester to indoxyl. A positive
reaction is indicated by a
light purple to dark purple
color.Granulocyte leukocytes
contain esterases that catalyze
the hydrolysis of the
derivatized pyrrole that react
with diazonium salt to produce
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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Page 2 -

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