The ACON Urinalysis Reagent Strips (Urine) are for qualitative and semi-quantitative detection of one or more of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes and Ascorbic Acid.

The ACON Urinalysis Reagent Strips (Urine) are for single use in professional nearpatient (point-of-care) and centralized laboratory locations. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas:

Kidney function .
Urinary track infections .
Carbohydrate metabolism (e.g. diabetes mellitus) .
Liver function .
Acid-base balance .
Urine concentration ●

The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The test is to be read visually. It is intended for professional use only.

Device Description

The ACON Urinalysis Reagent Strips are urine test strips of which Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocyte reagent pads are affixed onto the plastic strips. The reagent pads react with the urine and provide a visible color reaction. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. The product is packaged with a drying agent in a plastic bottle. The entire reagent strip is disposable when the disposal directions are followed exactly. Laboratory instrumentation is not required. These tests are intended for professional use with human urine.

AI/ML Overview

The provided text describes the ACON Urinalysis Reagent Strips, their intended use, and a comparison to predicate devices, but it does not contain specific acceptance criteria, detailed study results, or information about sample sizes for training/test sets, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, for aspects related to specific numerical acceptance criteria, detailed performance data, sample sizes, expert involvement, and comparative effectiveness studies, the information is not available in the provided document.

Here's an analysis of what information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document states that "performance characteristics... were verified by sensitivity study, reproducibility study, interference studies, temperature flex study, and stability studies," but it does not specify the quantitative acceptance criteria for these studies or present the detailed reported performance values against such criteria.

The submission focuses on establishing substantial equivalence based on intended use, target population, specimen type, materials, storage, test time, and methodologies used, which are listed as "Same" as the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Not available in the provided document. The document mentions "clinical studies were conducted at Beta sites" but does not specify the sample size for these studies or the country of origin. It also does not explicitly state whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not available in the provided document. The document states the "test is to be read visually" and "intended for professional use only," implying human interpretation. However, it does not detail how ground truth was established for the clinical studies, nor if experts were involved, their number, or their qualifications.

4. Adjudication Method for the Test Set

Not available in the provided document. There is no mention of any adjudication method (e.g., 2+1, 3+1) used for the test set.

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 performed or described. The document discusses "clinical accuracy of results" and "comparable testing data" between the ACON strips and predicate devices, which suggests an equivalence study rather than a comparative effectiveness study involving human readers with and without AI assistance (which is not relevant for this type of manual test).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Partially applicable, but not in the context of an algorithm. The device is a manual urinalysis reagent strip intended for visual reading by a professional. Therefore, the concept of an "algorithm only" or "standalone" performance study in the context of AI is not applicable. The device is the standalone test, and its performance is inherently tied to human interpretation of the visual reaction. The document does state that the test is "to be read visually" and "intended for professional use only."

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not explicitly stated for clinical studies. While the document describes the chemical reactions for each analyte (e.g., glucose, bilirubin, ketone, etc.), forming the basis of the test, it does not specify how the "ground truth" was established for the clinical studies used to compare the ACON strips to the predicate devices. For urinalysis, ground truth often involves laboratory reference methods, but this is not detailed here.

8. The Sample Size for the Training Set

Not applicable. The ACON Urinalysis Reagent Strips are a chemical test, not an AI/machine learning algorithm. Therefore, there is no "training set" in the computational sense. The product development would involve chemical optimization and validation, not model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, this is not an AI/machine learning device, so the concept of a training set and its ground truth establishment is not relevant.

Summary

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510(k) SUMMARY 5.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The Assigned 510(k) number is ________________________________________________________________________________________________________________________________________________

Submitter's Identification:

ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121

Tel.: 858-535-2030 Fax: 858-535-2039

Date Prepared: May 29, 2006

Contact Person:

Edward Tung, Ph.D. V.P., Regulatory Affairs

Proprietary Name of the Device:

ACON Urinalysis Reagent Strips

Common Name:

Urinalysis Reagent Strips

Regulation Section and Classification:

21 CFR § 862.1340	Urinary Glucose (Non-Quantitative) Test System
21 CFR § 862.1115	Urinary Bilirubin and its Conjugates (Non-Quantitative) Test System
21 CFR § 862.1435	Ketones (Non-Quantitative) Test System
21 CFR § 864.6550	Occult Blood Test
21 CFR § 862.1550	Urinary pH (Non-Quantitative) Test System
21 CFR § 862.1645	Urinary Protein or Albumin (Non-Quantitative) Test System
21 CFR § 862.1785	Urinary Urobilinogen (Non-Quantitative) Test System
21 CFR § 862.1510	Nitrite (Non-Quantitative) Test System

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21 CFR § 864.7675 Leukocyte Peroxidase Test
21 CFR § 862.1095 Ascorbic Acid Test System
Class I: Urinary Leukocytes, Urinary pH, Nitrite, Urinary Protein, Ketones, Urinary Urobilinogen Urinary Bilirubin, Specific Gravity and Ascorbic Acid

Class II: Urinary Glucose and Occult Blood

Product Code:

JIL	Urinary Glucose (non-quant.) test system
JIO	Blood, Occult, Colorimetric, in urine
LJX	Test, Urine Leukocyte
CEN	Urinary, pH (non-quant.)
JMT	Nitrite (urinary, non-quant.) test system
JIR	Protein or Albumin (urinary, non-quant.) test system
JIN	Ketones (urinary, non-quant.) test system
CDM	Urinary Urobilinogen (non-quant.) test system
JJB	Urinary Bilirubin & its conjugates (urinary, non-quant.) test system
JMA	Acid, Ascorbic, 2, 4-Dinitrophenylhydrazine (Spectrophotometric)

Medical Specialty:

Clinical Chemistry

Predicate Device:

Multistix 10 SG Reagent Strips for Urinalysis, K905396 Bayer Corporation, marketed by Bayer Corporation, located at Elkhart, IN 46515, USA.

QuickVue UrinChek 10+SG, K861255 Quidel Corporation, marketed by Quidel Corporation, located at San Diego, CA 92121, USA.

Device Description:

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disposal directions are followed exactly. Laboratory instrumentation is not required. These tests are intended for professional use with human urine.

Intended Use:

The ACON Urinalysis Reagent Strips are for qualitative and semi-quantitative detection of one or more of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes and Ascorbic acid. The ACON Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas:

Kidney function ●
Urinary track infections ●
Carbohydrate metabolism (e.g. diabetes mellitus) ●
Liver function ●
Acid-base balance ●
Urine concentration

Tests Principles:

Glucose: This test is based on the enzymatic reaction that occurs between glucose oxidase, peroxidase and chromogen. Glucose if first oxidized to produce gluconic acid and hydrogen peroxide in the presence of glucose oxidase. The hydrogen peroxide reacts with potassium iodide chromogen in the presence of peroxidase. The extent to which the chromogen is oxidized determines the color which is produced, ranging from green to brown. Low amounts of glucose are normally excreted in urine. Glucose concentrations as low as 100 mg/dL, read at either 10 or 30 seconds, may be considered abnormal if results are consistent.

Bilirubin: This test is based on azo-coupling reaction of bilirubin with diazotized dichloroaniline in a strongly acidic medium. Varying bilirubin levels will produce a pinkish-tan color proportional to its concentration in urine. In normal urine, no bilirubin is detectable by even the most sensitive methods. Even trace amounts of bilirubin require further investigation. Atypical results (colors different from the negative or positive color blocks shown on the color chart) may indicate that bilirubin-derived bile pigments are present in the urine specimen, and are possibly masking the bilirubin reaction.

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Ketone: This test is based on ketones reacting with nitroprusside and acetoacetic acid to produce a color change ranging from light pink for negative results to a darker pink or purple color for positive results. Ketones are normally not present in urine. Detectable ketone levels may occur in urine during physiological stress conditions such as fasting, pregnancy and frequent strenuous exercise. In starvation diets, or in other abnormal carbohydrate metabolism situations, ketones appear in the urine in excessively high concentration before serum ketones are elevated.

Specific Gravity: This test is based on the apparent pKa change of certain pretreated polyelectrolytes in relation to ionic concentration. In the presence of an indicator, colors range from deep blue-green in urine of low ionic concentration to green and yellow-green in urine of increasing ionic concentration. Randomly collected urine may vary in specific gravity from 1.003-1.035. Twenty-four hour urine from healthy adults with normal diets and fluid intake will have a specific gravity of 1.016-1.022. In cases of severe renal damage, the specific gravity is fixed at 1.010, the value of the glomerular filtrate.

Blood: This test is based on the peroxidase-like activity of hemoglobin which catalyzes the reaction of cumene-hydropcroxide and 3,3',5,5'-tetramethylbenzidine. The resulting color ranges from orange to green to dark blue. Any green spots or green color development on the reagent area within 60 seconds is significant and the vurine specimen should be examined further. Blood is often, but not invariably, found in the urine of menstruating females.

pH: This test is based on a double indicator system which gives a broad range of colors covering the entire urinary pH range. Colors range from orange to yellow and green to blue. The expected range for normal urine specimens from newborns is pH & For to expected range for other normal urine specimens is pH 4.5-8, with an average result of pH 6.

Protein: This reaction is based on the phenomenon known as the "protein error" of pH indicators where an indicator that is highly buffered will change color in the resence of proteins (anions) as the indicator releases hydrogen ions to the protein. At a prosence pH, the development of any green color is due to the presence of protein. Colors range from yellow to yellow-green for negative results and green to green-blue for positive results. 1-14 mg/dL of protein may be excreted by a normal kidney. A color matching any block greater than trace indicates significant proteinuria.

Urobilinogen: This test is based on a modified Ehrlich reaction between pdiethylaminobenzaldehyde and urobilinogen acid in strongly acidic medium to produce

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a pink color. Urobilinogen is one of the major compounds produced in heme this test is 0.2-1.0 mg/dL (3.5-17 umol/L). A result of 2.0 mg/dL (35 umol/L) may be of clinical significance, and the patient specimen should be further evaluated.

Nitrite: This test depends upon the conversion of nitrate to nitrite by the action of Gram negative bacteria in the urine. In an acidic medium, nitrite in the urine reacts with p-arsanilic acid to form a diazonium compound. The diazonium compound in turn couples with 1 N-(1-naphthyl)-ethylenediamine to produce a pink color. Nitrite is not detectable in normal urine. The nitrite area will be positive in some cases of infection, depending on how long the urine specimens were retained in the bladder prior to collection. Retrieval of positive cases with the nitrite test ranges from as low as 40% in cases where little bladder incubation occurred, to as high as approximately 80% in cases where bladder incubation took place for at least 4 hours.

Leukocytes: This test reveals the presence of granulocyte esterases. The esterases cleave a derivatized pyrazole amino acid ester to liberate derivatized hydroxy pyrazole. This pyrazole then reacts with a diazonium salt to produce a beige-pink to purple color. Normal urine specimens generally yield negative results. Trace results may be of questionable clinical significance. When trace results occur, it is recommended to retest using a fresh specimen from the same patient. Repeated trace and positive results are of clinical significance.

Ascorbic acid: This test involves decolorization of Tillmann's reagent. The presence of ascorbic acid causes the color of the test field to change from blue-green to orange.

Substantial Equivalence:

The ACON Urinalysis Reagent Strips are substantially equivalent to the Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396) and the Quidel QuickVue UrinChek 10+SG (K861255).

Characteristic of the ACON Urinalysis Reagent Strips are compared with the Bayer Multistix 10 SG system (K905396) in the following table:

Area of Comparison	ACON Urinalysis Reagent Strips	Bayer Multistix 10 SG ReagentStrips for Urinalysis (K905396)
Intended Use	Professional use in point-of-careurine testing	Same
Target Population	Patients of physicians, hospitals,and clinics	Same
Intended Specimen	Urine	Same
Material Provided	Plastic strips affixed with several	Same
	separate reagent areas.2 to 30℃
StorageTest Time	Varies from 30 Seconds to 2 Minutes	15 to 30℃
		Same
Glucose Methodology	Based on the enzymatic reaction thatoccurs between glucose oxidase.peroxidase and chromogen. Glucoseif first oxidized to produce gluconicacid and hydrogen peroxide in thepresence of glucose oxidase. Thehydrogen peroxide reacts withpotassium iodide chromogen in thepresence of peroxidase. The extent towhich the chromogen is oxidizeddetermines the color which isproduced, ranging from green tobrown.	Same
Bilirubin Methodology	Based on azo-coupling reaction ofbilirubin with diazotizeddichloroaniline in a strongly acidicmedium. Varying bilirubin levelswill produce a pinkish-tan colorproportional to its concentration inurine.	Same
Ketone Methodology	Based on ketones reacting withnitroprusside and acetoacetic acid toproduce a color change rangingfrom light pink for negative resultsto a darker pink or purple color forpositive results.	Same
Specific GravityMethodology	Based on the apparent pKa changeof certain pretreated polyelectrolytesin relation to ionic concentration. Inthe presence of an indicator, colorsrange from deep blue-green in urineof low ionic concentration to greenand yellow-green in urine ofincreasing ionic concentration.	Same
Blood Methodology	Based on the peroxidase-likeactivity of hemoglobin whichcatalyzes the reaction of cumene-hydroperoxide and 3,3',5,5'-tetramethylbenzidine. The resultingcolor ranges from orange to greento dark blue.	Same
pH Methodology	Based on a double indicator systemwhich gives a broad range of colorscovering the entire urinary pHrange. Colors range from orange toyellow and green to blue.	Same

Protein Methodology	Based on the phenomenon known as the "protein error" of pH indicators where an indicator that is highly buffered will change color in the presence of proteins (anions) as the indicator releases hydrogen ions to the protein. At a constant pH, the development of any green color is due to the presence of protein. Colors range from yellow to yellow-green for negative results and green to green-blue for positive results.	Same
Urobilinogen Methodology	Based on a modified Ehrlich reaction between p-diethylamino-benzaldehyde and urobilinogen acid in strongly acidic medium to produce a pink color.	Same
Nitrite Methodology	This test depends upon the conversion of nitrate to nitrite by the action of Gram negative bacteria in the urine. In an acidic medium, nitrite in the urine reacts with p-arsanilic acid to form a diazonium compound. The diazonium compound in turn couples with 1 N-(1-naphthyl)-ethylenediamine to produce a pink color.	Same
Leukocyte Methodology	This test reveals the presence of granulocyte esterases. The esterases cleave a derivatized pyrazole amino acid ester to liberate derivatized hydroxy pyrazole. This pyrazole then reacts with a diazonium salt to produce a beige-pink to purple color.	Same

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Area of Comparison	ACON Urinalysis Reagent Strips	Quidel QuickVue UrinChek10+SG (K861255)
Ascorbic AcidMethodology	This test involves decolorization ofTillmann's reagent. The presence ofascorbic acid causes the color of thetest field to change from blue-greento orange.	Same

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Discussion of Clinical Tests Performed:

The clinical studies were conducted at Beta sites using the ACON Urinalysis Reagent Strips (Section 20, page 56 of this submission). Clinical data were presented evaluating clinical accuracy of results. Clinical study results indicate that the intended users were able to obtain comparable testing data when using the ACON Urinalysis Reagent Strips and the legally marketed Bayer Multistix 10 SG Reagent Strips for Urinalysis (K905396) and the Quidel QuickVue UrinChek 10+SG (K861255).

Conclusion:

The performance characteristics of the ACON Urinalysis Reagent Strips were verified by sensitivity study, reproducibility study, interference studies, temperature flex study, and stability studies. Testing results indicate that the ACON Urinalysis Reagent Strips are robust and can perform satisfactorily when used according to the "Directions for Use" statement specified in the package insert.

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Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes, rendered in blue.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

ACON Laboratories, Inc.

MAY 20 2010

c/o Ms Joy Slape 10125 Mesa Rim Road San Diego, CA 92121

Re: K061559 Trade Name: ACONTM Urinalysis Reagent Strips Regulation Number: 21 CFR§862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: Class II Product Codes: JIL, JIO, LJX, CEN, JMT, JIR, JIN, CDM, JJB, JMA, JRE Dated: July 14.2006 Received: July 18, 2006

Dear Ms. Joy Slape:

This letter corrects our substantially equivalent letter of August 11, 2006. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney C. Harper, 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 4.

510(k) Number (if known): K061559

ACON Urinalysis Reagent Strips Device Name:

Indications for Use:

Kidney function .
Urinary track infections .
Carbohydrate metabolism (e.g. diabetes mellitus) .
Liver function .
Acid-base balance .
Urine concentration ●

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

Over-The-Counter Use __ (21 CFR 807

(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. Bensen
Division Sign-Off

Page 1 of 1

Office of In Vitro Diagnostic Device Evaluation and Safety

.:*) K061559

Regulation Number and Section

§ 862.1785 Urinary urobilinogen (nonquantitative) test system.

(a)
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.(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.