The Mission Urinalysis Reagent strips (Microalbumin/Creatinine) are intended for the semi quantitative measurement of albumin and creatinine in urine samples using the Mission U120 Urine Analyzer. These measurements are used to assist diagnosis for kidney function. It is intended for professional use only at point-of-care locations.

Device Description

The Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) are firm plastic strips that contain two reagent areas to test for Microalbumin (low concentration of albumin) and creatinine in urine. Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) can be read by the Mission® U120 Urine Analyzer.

AI/ML Overview

The provided document describes the clinical performance and acceptance criteria for the Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) device. This device is intended for the semi-quantitative measurement of albumin and creatinine in urine samples using the Mission U120 Urine Analyzer, to assist in diagnosing kidney function.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document compares the new device against a predicate device (CLINITEK Microalbumin Reagent Strips) to establish substantial equivalence. The primary performance metric presented is agreement in classifying Albumin-to-Creatinine (A:C) ratios.

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance
Overall exact agreement with predicate device for A:C ratios	89.2%
Overall agreement within ±1 block with predicate device for A:C ratios	100%
Agreement at same block for A:C < 30	91.6%
Agreement at same block for A:C 30-300	87.5%
Agreement at same block for A:C > 300	86.7%
Agreement within ±1 block for A:C < 30	100%
Agreement within ±1 block for A:C 30-300	100%
Agreement within ±1 block for A:C > 300	100%
Positive Agreement (A:C ratios)	90.6%
Negative Agreement (A:C ratios)	91.6%
Within-run precision (agreement with target concentration)	>99%
Between-run precision (agreement with target concentration)	>99%

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

Sample Size: 390 urine specimens.
Data Provenance: Retrospective, collected randomly at three clinical sites from patients. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a company based in San Diego, CA, suggesting U.S. clinical sites.

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

The "ground truth" for the test set was established by comparing the results of the new device (Mission® Urinalysis Reagent Strips read by Mission U120 Urine Analyzer) to the predicate device (CLINITEK Microalbumin Reagent Strips read by Clinitek Status Analyzer). No independent human experts were stated to have established a separate ground truth for the clinical accuracy study. The predicate device itself acts as the reference for comparison.

4. Adjudication Method for the Test Set:

No explicit adjudication method (like 2+1 or 3+1) is mentioned. The study directly compares the results of the new device against the predicate device for each specimen.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is an in-vitro diagnostic (IVD) test strip read by an analyzer, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

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

Yes, the performance study is a standalone evaluation of the device system (reagent strips + analyzer). The device itself performs the semi-quantitative measurement. While human operators are involved in dipping the strips and initiating the reading, the "performance" described is that of the automated analytical system in interpreting the strip's reaction.

7. The Type of Ground Truth Used:

The ground truth for the clinical accuracy study was the results obtained from a legally marketed predicate device (CLINITEK Microalbumin Reagent Strips read by Clinitek Status Analyzer). This is a common approach for demonstrating substantial equivalence for new IVD devices.

8. The Sample Size for the Training Set:

The document does not explicitly mention a "training set" in the context of machine learning or AI. For a traditional IVD device like this, the development and calibration of the reagent strips and analyzer would involve extensive internal testing and optimization, but it's not typically referred to as a "training set" in the same way as for AI algorithms. The clinical accuracy study used 390 specimens.

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

As there's no explicitly defined "training set" in the AI sense for this type of IVD device, the method for establishing its ground truth isn't applicable. The performance is based on the chemical reactions of the strips and the optical reading capabilities of the analyzer, which would have been rigorously developed and validated against known concentrations of analytes and reference methods during the product development phase.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 30, 2015

ACON LABORATORIES, INC. QIYI XIE SR.STAFF REGULATORY AFFAIRS/CLINICAL AFFAIRS 10125 MESA RIM ROAD SAN DIEGO CA 92121

Re: K150330

Trade/Device Name: Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) Regulation Number: 21 CFR 862.1645 Regulation Name: Urinary protein or albumin (nonquantitative) test system Regulatory Class: II Product Code: JIR, JFY Dated: February 7, 2015 Received: February 10, 2015

Dear Oiyi Xie:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -S

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150330

Device Name

Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMAR Y

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: K150330

Submitter's Identification:

ACON Laboratories, Inc.

10125 Mesa Rim Road

San Diego, California 92121

Tel.: 858-875-8019

Fax: 858-875-8011

Date Prepared: February 7, 2015

Contact Person:

Qiyi Xie Senior Staff, Clinical & Regulatory Affairs Email: qxie@aconlabs.com

Proprietary Name of the Device:

Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine)

Common Name:

Urinalysis Reagent Strips

Classification Name:

21 CFR 862.1645 Urinary protein or albumin (nonquantitative) test system
21 CFR 862.1225 Creatinine test system

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Predicate Device: CLINITEK Microalbumin Reagent Strips BAYER CORPORATION 1884 Miles Avenue, P.O. Box 70 Elkhart, IN 46515 510(k) Number: K972706

Proprietary Name	Classification	Product	Description	Common Name
Mission® UrinalysisReagent Strips(Microalbumin/Creatinine)	862.1645Class I	JIR	Urinary Protein orAlbumin(nonquantitative) testsystem	UrinalysisReagentStrips
	862.1225Class II	JFY	Creatinine testsystem

Device Name: Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine)

Device Description:

Instrument Reading

The Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) are dipped into a urine specimen and "read" instrumentally by the Mission" U120 Urine Analyzer, (K070929). The urine analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip. In addition to providing an albumin and a creatinine result, an albumin-to-creatinine ratio can also be determined. Semi-quantitative results are available within one minute.

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Intended Use:

Tests Principles:

Albumin: The basis for the test is a high affinity sulfonephthalein dye, using the dye binding method to produce any blue color if albumin is present at a constant pH. Results range in color from pale green to aqua blue. In the presence of diluted urine, the pad for the Albumin reading will turn white. This indicates an albumin level ≤ 10 mg/L. Normally, albumin is present in urine at concentrations < 20 mg/L. Results of 20-200 mg/L may indicate micralbuminuria. It is associated with early-stage kidney disease when a small amount of Albumin, also called Microalbumin is consistently present in urine. Clinical albuminuria is indicated by results of >200 mg/L. These levels can be predictive of albumin excretion rates of 30-300 mg/24hours and >300 mg/24hours, respectively. Exercise, acute illness and fever, and urinary tract infections may temporarily elevate urinary albumin excretions.

Creatinine: The peroxidase-like activity of a copper creatinine complex catalyzes the reaction of diisopropylbenzene dihydroperoxide and 3,3 ',5,5'-tetramethylbenzidine to produce a resulting color range from orange through green to blue. Creatinine concentrations of 10-300 mg/dL are normally present in urine.

Albumin-to-Creatinine Ratio: It is also called Microalbumin-to-Creatinine ratio test available to assess microalbuminuria. Albumin is normally present in urine at concentrations of <30 mg albumin/g creatinine. Microalbuminuria is indicated at a ratio result of 30-300 mg/g (Abnormal) and clinical albuminuria at a ratio of >300 mg/g (High Abnormal).

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Substantial Equivalence:

The Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) are substantially equivalent to the CLINITEK Microalbumin Reagent Strips (K972706)

Characteristic of the Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) are compared with the CLINITEK Microalbumin Reagent Strips (K972706) for instrument reading in the following table:

Area of Comparison	Mission® Urinalysis ReagentStrips(Microalbumin/Creatinine)	CLINITEK MicroalbuminReagent Strips (K972706)
Indications for Use	The Mission Urinalysis Reagentstrips (Microalbumin/Creatinine)are intended for the semiquantitative measurement ofalbumin and creatinine in urinesamples using the Mission U120Urine Analyzer. Thesemeasurements are used to assistdiagnosis for kidney function. Itis intended for professional useonly at point-of-care locations.The strips are readinstrumentally by the Mission®U120 urine analyzer.	Clinitek Microalbumin ReagentStrips are for screening urinespecimens to test for smallamounts of albumin in urine(microalbuminuria), creatinine inurine, and also determine thealbumin-to-creatinine ratio inurine. Clinitek MicroalbuminReagent Strips can be used forscreening urine specimens formicroalbuminuria as an aid inthe detection of patients at riskfor developing kidney damage.The strips are readinstrumentally using theClinitek Status Analyzer(K031947).
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 twoseparate reagent areas.	Same
Test Time	1 Minute	Same
AlbuminMethodology	This test is based on dye bindingusing a high affinity	Same
	sulfonephthalein dye. At a constantpH, the development of any bluecolor is due to the presence ofalbumin. The resulting colorranges from pale green to aquablue
CreatinineMethodology	This test is based on theperoxidase-like activity of a coppercreatinine complex that catalyzesthe reaction of diisopropylbenzenedihydroperoxide and 3,3',5,5'-tetramethylbenzidine. Theresulting color ranges from orangethrough green to blue	Same
Detection	Detects albumin between 10-150mg/LDetects creatinine between10-300 mg/dL (0.9 -26.5 mmol/L)	Same
Differences
Storage	2 to 30°C	15 to 30°C

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Discussion of Clinical Accuracy Tests Performed:

A total of 390 urine specimens were randomly collected at three clinical sites from patients. Each specimen was tested by Mission U120 Urine Analyzer with Mission Urinalysis Microalbumin/Creatinine Reagent strip and predicate device. The results are summarized in the

table below:

A:C	Predicate Device
	<30	30-300	>300	Total
Mission	164	12	0	176
Urinalysis	15	112	11	138
Reagent Strips	0	4	72	76

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	179	128	83
Agreement at same block	91.6%	87.5%	86.7%
Agreement within ±1 block	100%	100%	100%
Positive Agreement		90.6%	100%
Negative Agreement	91.6%
Agreement within same block		89.2%
Agreement within ±1 block		100%

The agreement of A:C ratios of positives and negatives at cutoff of <30 mg/g were 94.3% and 91.6%, respectively. Of the 211 A:C positive results, 5.7% (12/211) were negative. Of the 179 assay A:C ratio negative results, 8.4% (15/179) were positive. In summary, the overall exact agreement between Mission Urinalysis Strips Microalbumin/Creatinine) and Clinitek Microalbumin 2 Reagents strips for positive albumin results is 89.2%, and the overall agreement for ±1 block is 100%.

Discussion of Performance Tests Performed:

The performance characteristics of the Urinalysis Reagent Strips (Urine) have been determined in both laboratory and clinical tests. Parameters of importance to the user are sensitivity, specificity, accuracy and precision. Generally, this test has been developed to be specific for the parameters to be measured with the exceptions of the interferences listed.

Precision: The reproducibility of the Mission U120 Urine Analyzer to read Mission®

Urinalysis Reagent Strips (Microalbumin/ Creatinine) was evaluated by within run precision and between run precision studies at three POL sites using Control Solutions Level 1 (Neg.), Level 2 (Low) and Level 3 (High). Within run precision study: Each level of the control solution was tested in 20 replicates in one day at each of POL sites. Between run precision study: Each control was tested once at each run, 2 runs per day for 20 days, 3 operators from each site participated the study. The results of within-run and between-run precision studies showed that the agreements with each target concentration were over 99% for the U120 Ultra.

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Interference Study: Three levels of urine controls were spiked with the possible interfering substances one at a time to two concentrations following EP7-A2: Level 2 (common pathological value) and level 1 (5 times lower than level 2). Each sample was tested in triplicates. Results are summarized in the table below:

Substances	Conc. Tested	Interference on the Testing Result
		Result of Albumin	Result of Creatinine
Human IgG	25 mg/dL	+1	N/A
Sodium Bicarbonate	1500 mg/dL	+2	N/A
Potassium Chloride	1500 mg/dL	-2	N/A
Hemoglobin	10 mg/dL	+1	+1
Blood	0.05%	+2	+1

Conclusion:

The laboratory testing results and clinical studies demonstrate that the Mission® Urinalysis Reagent Strips (Microalbumin/ Creatinine) read by Mission® U120 Urine Analyzer is safe, effective and easy-to-use and such is substantially equivalent to the Clinitek Microalbumin Reagent Strips (K972706) read by Clinitek Status Analyzer (K031947), currently sold on the U.S. market for professional use at point-of-care locations.

Regulation Number and Section

§ 862.1645 Urinary protein or albumin (nonquantitative) test system.

(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.(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.