(117 days)
Not Found
No
The device description and performance studies focus on reflectance photometry and standard analytical methods, with no mention of AI or ML.
No.
The device is an in vitro diagnostic (IVD) instrument used to read urinalysis reagent strips for the semi-quantitative measurement of Albumin and Creatinine, which assist in the diagnosis of kidney function. It does not provide treatment or directly apply therapy to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that "These measurements are used to assist diagnosis for kidney function." This indicates the device's role in diagnosing health conditions.
No
The device description explicitly states it is a "reflectance photometer" and analyzes light, indicating it is a hardware device with software components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The Mission® U120 Ultra Urine Analyzer is an urinalysis instrument intended for in vitro diagnostic use."
- Purpose of the Device: The device is designed to analyze urine samples (in vitro) to measure specific analytes (Albumin and Creatinine) for the purpose of assisting in the diagnosis of kidney function. This aligns directly with the definition of an in vitro diagnostic device.
- Use of Reagent Strips: The device uses reagent strips that react with the urine sample outside of the body, which is a characteristic of in vitro testing.
- Clinical Studies: The document describes clinical studies where the device was used to test patient urine specimens and the results were compared to a predicate device, further indicating its use in a diagnostic context.
N/A
Intended Use / Indications for Use
The Mission® U120 Ultra Urine Analyzer is an urinalysis instrument intended for in vitro diagnostic use. It is intended for professional use only at point-of-care locations. The Mission U120 Ultra Urine Analyzer is intended to read Mission® Urinalysis Reagent strips (Microalbumin/Creatinine) for the semi quantitative measurement of Albumin and Creatinine. These measurements are used to assist diagnosis for kidney function.
The Mission® Liquid Urine Controls and Mission® Liquid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for the Creatinine and Albumin analytes.
Product codes
JFY, KQO, JIR, JJW
Device Description
The Mission® U120 Ultra Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip.
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) are to be read by the Mission® U120 Ultra Urine Analyzer.
The Mission® Liquid Urine Controls and Mission® Liguid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for the Creatinine and Albumin analytes.
Mentions image processing
Using a light emitting diode (LED) as the light source and a CMOS image sensor as a light sensor, the optical system reads the color change in the urine test strips after a sample is applied.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Reflectance Photometer
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
A total of 429 urine specimens were randomly collected at three clinical sites from patients. Each specimen was tested by ACON U120 Ultra Urine Analyzer with ACON Urinalysis Microalbumin/Creatinine Reagent strip and predicate device.
Summary of Performance Studies
Clinical studies were conducted using the Mission® U120 Ultra Urine Analyzer and Mission® Urinalysis Microalbumin/Creatinine Reagent strips. Clinical study data is presented evaluating clinical accuracy of Mission® Urinalysis Microalbumin/Creatinine Reagent strip read by Mission® U120 Ultra Urine Analyzer compared to the predicate: Clinitek Microalbumin 2 Reagent Strips (K972706) read by Clinitek Status Analyzer (K031947).
A total of 429 urine specimens were randomly collected at three clinical sites from patients. Each specimen was tested by ACON U120 Ultra Urine Analyzer with ACON Urinalysis Microalbumin/Creatinine Reagent strip and predicate device.
The performance characteristics of the Mission® U120 Ultra Urine Analyzer to read Mission® Urinalysis Reagent Strips (Microalbumin/ Creatinine) were verified by Precision study, Interference study, Temperature flex study, voltage flex study, SG flex study, Humidity flex study, sensitivity study, stability study, electrical safety testing and EMC testing. Laboratory testing results indicate that the Mission® U120 Ultra Urine Analyzer is robust and can perform satisfactorily when used according to the "Indication for Use" statement specified in the Instruction Manual and Package Insert of the device.
Precision: The reproducibility of the Mission U120 Ultra Urine Analyzer 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 betweenrun precision studies showed that the agreements with each target concentration were over 99% for the U120 Ultra.
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.
Key Metrics
Albumin Results with Mission U120 Ultra: Accuracy 86.5% (n=429), Sensitivity 97.6% (n-293), Specificity 92.6% (n=136)
Albumin-to-Creatinine Ratio with Mission U120 Ultra: Accuracy 90.7% (n=429), Sensitivity 93.1% (n=233), Specificity 94.9% (n=196)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three faces in profile, stacked on top of each other. The symbol is black and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2014
ACON LABORATORIES, INC. QIYI XIE SR. STAFF REGULATORY AFFAIRS/ CLINICAL AFFAIRS 10125 MESA RIM ROAD SAN DIEGO CA 92121
Re: K142391
Trade/Device Name: MISSION® U120 Ultra Urine Analyzer, MISSION® Urinalysis Reagent Strips ( Microalbumin/creatinine )
MISSION® Liquid Urine Controls, MISSION® Diptube Urine Controls
Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: II Product Code: JFY, KQO, JIR, JJW Dated: November 6, 2014 Received: November 7, 2014
Dear Qiyi 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
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/ResourcesforYou/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,
Stayce Beck -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
2
Indications for Use
510(k) Number (if known) K142391
Device Name
Mission® U120 Ultra Urine Analyzer Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) Mission® Liquid Urine Controls, Mission® Liquid Diptube Urine Controls
Indications for Use (Describe)
The Mission® U120 Ultra Urine Analyzer is an urinalysis instrument intended for in vitro diagnostic use. It is intended for professional use only at point-of-care locations. The Mission U120 Ultra Urine Analyzer is intended to read Mission® Urinalysis Reagent strips (Microalbumin/Creatinine) for the semi quantitative measurement of Albumin and Creatinine. These measurements are used to assist diagnosis for kidney function.
The Mission® Liquid Urine Controls and Mission® Liquid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for the Creatinine and Albumin analytes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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7. 510(k) SUMMARY
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 K142391.
Submitter's Identification:
ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, California 92121 Tel.: 858-875-8019 Fax: 858-875-8011
Date Prepared: December 22, 2014
Contact Person:
Qiyi Xie Senior Staff, Clinical & Regulatory Affairs Email: qxie(@aconlabs.com
Proprietary Name of the Device:
Mission® U120 Ultra Urine Analyzer Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) Mission® Liquid Urine Controls, Mission® Liquid Diptube Urine Controls
Common Name:
Urine Chemistry Analyzer Urinalysis Reagent Strips Urinalysis Controls (Assayed and Unassayed)
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Classification Name:
Class II §21 CFR 862.2900, Automated Urinalysis System
21 CFR 862.1645 Urinary protein or albumin (nonquantitative) test system
21 CFR 862.1225 Creatinine test system
21 CFR 862.1660 Urinalysis Controls (Assayed And Unassayed)
Predicate Device:
Bayer Clinitek Status Analyzer
BAYER HEALTHCARE, LLC
63 North St.
Medfield, MA 02052 -1688
510(k) Number: K031947
CLINITEK Microalbumin Reagent Strips
BAYER CORPORATION
1884 Miles Avenue, P.O. Box 70
Elkhart, IN 46515
510(k) Number: K972706
Biorad Liquicheck Urinalysis control
BIO-RAD
9500 Jeronimo Rd.
Irvine, CA 92618
510(k) Number: K070848
Device Name: Mission® U120 Ultra Urine Analyzer,
Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine)
Mission® Liquid Urine Controls, Mission® Liquid Diptube Urine Controls
| Proprietary Name | Classification | Product
Code | Description | Common
Name |
|---------------------------------------|---------------------|-----------------|-----------------------------------|--------------------------------|
| Mission® U120 Ultra
Urine Analyzer | 862.2900
Class I | KQO | Automated
Urinalysis
System | Urine
Chemistry
Analyzer |
5
| Mission® Urinalysis
Reagent Strips
(Microalbumin/Creatinine) | 862.1645 –
Class I
862.1225 –
Class II | JIR
JFY | Urinalysis
Reagent Strips | Urinalysis
Reagent
Strips |
|---------------------------------------------------------------------------------|-------------------------------------------------|------------|-----------------------------------------------------------|---------------------------------------------------------|
| Mission® Liquid Urine
Controls, Mission®
Liquid Diptube Urine
Controls | 862.1660
Class I | JJW | Quality control
material
(assayed and
unassayed) | Urinalysis
Controls
(Assayed
And
Unassayed) |
Device Description:
The Mission® U120 Ultra Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip.
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) are to be read by the Mission® U120 Ultra Urine Analyzer.
The Mission® Liquid Urine Controls and Mission® Liguid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for the Creatinine and Albumin analytes.
Intended Use:
The Mission® U120 Ultra Urine Analyzer is an urinalysis instrument intended for in vitro diagnostic use. It is intended for professional use only at point-of-care locations. The Mission U120 Ultra Urine Analyzer is intended to read Mission® Urinalysis Reagent strips (Microalbumin/Creatinine) for the semi quantitative measurement of Albumin and Creatinine. These measurements are used to assist diagnosis for kidney function.
The Mission® Liguid Urine Controls and Mission® Liguid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for the Creatinine and Albumin analytes.
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Tests Principles:
The Mission® U120 Ultra Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip. Using a light emitting diode (LED) as the light source and a CMOS image sensor as a light sensor, the optical system reads the color change in the urine test strips after a sample is applied.
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 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).
Urine Controls: The Mission® Liquid Urine Controls and Mission® Liquid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for the Creatinine and Albumin analytes.
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Technological Characteristics:
| Feature | Mission® U120 Ultra Urine Analyzer |
|---|---|
| Methodology | Reflectance Photometer |
| Detection | CMOS Image Sensor |
| Chemistry | Mission® Urinalysis Reagent Strips |
| (Microalbumin/Creatinine) | |
| Throughput | Single Test Mode: 55 tests/hour |
| Continuous Test Mode: 120 tests/hour | |
| Memory | Last 2000 results |
| Strip Incubation Time | 1 minute |
| PC Port | USB (data communications); |
| (Not connect to PC) | |
| Bluetooth Wireless | |
| Standard RS232C Port | |
| Capabilities | Internal thermal printer |
| Barcode reader Connector | |
| External printer (optional) | |
| Barcode reader (optional) | |
| RJ45 Ethernet; (optional) | |
| Available Languages on Screen | English and Spanish |
| Analyzer Operating Conditions | 0-40°C (32-104°F); ≤85% Relative Humidity |
| (non-condensing) | |
| Strip Operating Conditions | 15-30°C (59-86°F); 20-80% Relative Humidity |
| (non-condensing) | |
| Power Source | 6 AA batteries with 100 tests/6 new batteries; |
| 100- 240 VAC(adapter), (50-60 Hz± 1HZ) | |
| Weight | ≤1.66 kg (3.65 lb) without batteries or power |
| supply | |
| Dimensions (L X W X H) | 26.0 (L) x 15.0 (W) x 17.5 (H) cm |
| (10.2"x 5.9"x 6.9") |
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| Display Dimensions (L X W) | Large touch screen Color LCD |
|---|---|
| TFT 640x480, 11.7 (W) x 8.8 (H) cm |
Substantial Equivalence:
The Mission® U120 Ultra Urine Analyzer is substantially equivalent to the Bayer Clinitek Status Analyzer (K031947)
| Feature | Mission® U120 Ultra Urine
Analyzer | Clinitek Status Analyzer
(K031947) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Methodology | Reflectance Photometer | Reflectance Photometer |
| Principle | The U120 Ultra Urine Analyzer
measures the intensity of the light
reflected from the reagent areas of
a urinalysis reagent strip. | The Clinitek Status Analyzer
measures the intensity of the
light reflected from the reagent
areas of a urinalysis reagent
strip. |
| Parameters Detected | Albumin and Creatinine | Albumin and Creatinine |
| Calculated Parameters | Albumin: Creatinine Ratio | Albumin: Creatinine Ratio |
| Available Languages on
Screen | English and Spanish | English and Spanish |
| Line Leakage Current |