K Number
K150330
Device Name
Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)
Date Cleared
2015-04-30

(79 days)

Product Code
Regulation Number
862.1645
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

No
The summary describes a reagent strip and an analyzer that reads the strip. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis is based on chemical reactions on the strip read by the analyzer.

No
The device is a diagnostic reagent strip intended to measure specific substances in urine to assist in the diagnosis of kidney function, not to treat a condition.

Yes
The "Intended Use / Indications for Use" section explicitly states that "These measurements are used to assist diagnosis for kidney function."

No

The device description explicitly states it is a "firm plastic strip" containing reagent areas, which is a hardware component. The software (Mission U120 Urine Analyzer) is a separate device used to read the strips.

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

Here's why:

  • Intended Use: The intended use explicitly states it's for the "semi quantitative measurement of albumin and creatinine in urine samples." This is a measurement performed in vitro (outside the body) on a biological sample (urine).
  • Purpose: The measurements are used to "assist diagnosis for kidney function." This aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description: It describes "reagent areas to test for Microalbumin... and creatinine in urine," which are components of an IVD test.
  • Performance Studies: The document details clinical accuracy tests and precision studies using urine specimens, which are standard evaluations for IVD devices.
  • Predicate Device: A predicate device (CLINITEK Microalbumin Reagent Strips) is listed, which is also an IVD.

Therefore, based on the provided information, the Mission Urinalysis Reagent strips (Microalbumin/Creatinine) clearly fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

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.

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

JIR, JFY

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

professional use only at point-of-care locations.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

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

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:

Agreement at same block
300: 86.7%

Agreement within ±1 block
300: 100%

Positive Agreement: 90.6%
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 300: 86.7%

Agreement within ±1 block
300: 100%

Positive Agreement: 90.6%
Negative Agreement: 91.6%

Overall exact agreement: 89.2%
Overall agreement for ±1 block: 100%

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.

K972706

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.

Not Found

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).

Not Found

§ 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.

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Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with flowing lines suggesting movement or connection.

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.

1

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)

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.

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

4

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

Proprietary NameClassificationProductDescriptionCommon Name
Mission® Urinalysis
Reagent Strips
(Microalbumin/Creatinine)862.1645
Class IJIRUrinary Protein or
Albumin
(nonquantitative) test
systemUrinalysis
Reagent
Strips
862.1225
Class IIJFYCreatinine test
system

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

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.

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.

5

Intended Use:

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.

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 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 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 Reagent
Strips
(Microalbumin/Creatinine) | CLINITEK Microalbumin
Reagent Strips (K972706) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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.

The strips are read
instrumentally by the Mission®
U120 urine analyzer. | Clinitek Microalbumin Reagent
Strips are for screening urine
specimens to test for small
amounts of albumin in urine
(microalbuminuria), creatinine in
urine, and also determine the
albumin-to-creatinine ratio in
urine. Clinitek Microalbumin
Reagent Strips can be used for
screening urine specimens for
microalbuminuria as an aid in
the detection of patients at risk
for developing kidney damage.

The strips are read
instrumentally using the
Clinitek Status Analyzer
(K031947). |
| Intended Use | Professional use in point-of-care
urine testing | Same |
| Target Population | Patients of physicians, hospitals,
and clinics | Same |
| Intended Specimen | Urine | Same |
| Material Provided | Plastic strips affixed with two
separate reagent areas. | Same |
| Test Time | 1 Minute | Same |
| Albumin
Methodology | This test is based on dye binding
using a high affinity | Same |
| | sulfonephthalein dye. At a constant
pH, the development of any blue
color is due to the presence of
albumin. The resulting color
ranges from pale green to aqua
blue | |
| Creatinine
Methodology | This test is based on the
peroxidase-like activity of a copper
creatinine complex that catalyzes
the reaction of diisopropylbenzene
dihydroperoxide and 3,3',5,5'-
tetramethylbenzidine. The
resulting color ranges from orange
through green to blue | Same |
| Detection | Detects albumin between 10-150
mg/L
Detects creatinine between
10-300 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:CPredicate Device
300Total
Mission164120176
Urinalysis1511211138
Reagent Strips047276

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Total17912883390
Agreement at same block91.6%87.5%86.7%
Agreement within ±1 block100%100%100%
Positive Agreement90.6%100%
Negative Agreement91.6%
Agreement within same block89.2%
Agreement within ±1 block100%

The agreement of A:C ratios of positives and negatives at cutoff of