(117 days)
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.
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.
Here's an analysis of the acceptance criteria and study information provided for the MISSION® U120 Ultra Urine Analyzer and associated reagent strips and controls:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the clinical accuracy study in terms of specific percentages for accuracy, sensitivity, and specificity. However, it presents the reported performance values. We can infer that these values were deemed acceptable for substantial equivalence.
| Metric | Acceptance Criteria (Inferred) | Reported Device Performance (Mission® U120 Ultra) |
|---|---|---|
| Albumin Results | ||
| Overall Accuracy | Not explicitly stated, likely similar to predicate if not superior for substantial equivalence. | 86.5% (n=429) |
| Sensitivity | Not explicitly stated. | 97.6% (n=293) |
| Specificity | Not explicitly stated. | 92.6% (n=136) |
| Albumin-to-Creatinine Ratio | ||
| Overall Accuracy | Not explicitly stated. | 90.7% (n=429) |
| Sensitivity | Not explicitly stated. | 93.1% (n=233) |
| Specificity | Not explicitly stated. | 94.9% (n=196) |
Regarding the Precision Study:
| Metric | Acceptance Criteria (Inferred) | Reported Device Performance (Mission® U120 Ultra) |
|---|---|---|
| Agreement with target concentration for within-run and between-run precision | Not explicitly stated, but likely >95% or similar to predicate. | Over 99% agreement |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Accuracy: A total of 429 urine specimens were used.
- Data Provenance: The specimens were "randomly collected at three clinical sites from patients." The document does not specify the country of origin, but given the FDA filing, it's typically understood to be within the United States or from sites compliant with US regulations. The data is prospective as it involves new testing of collected specimens.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states that the clinical study data for accuracy involved comparing the Mission® U120 Ultra Urine Analyzer results against those obtained from a predicate device (Clinitek Microalbumin 2 Reagent Strips read by Clinitek Status Analyzer).
Therefore, the "ground truth" for the clinical accuracy study was established by the predicate device's readings, rather than by human experts directly interpreting raw data. No specific number of experts or their qualifications are mentioned in this context, as the comparison is device-to-device.
4. Adjudication Method for the Test Set
Not applicable. The study compares the new device's readings against a predicate device. There is no mention of an adjudication method involving human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or reported in this document. This device is an automated analyzer, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance study was done. The reported accuracy, sensitivity, and specificity for Albumin and Albumin-to-Creatinine Ratio are based on the Mission® U120 Ultra Urine Analyzer's readings without human intervention. The device is described as a "reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas," indicating automated measurement.
7. The Type of Ground Truth Used
The ground truth for the clinical accuracy study was established by comparison with a legally marketed predicate device: "Clinitek Microalbumin 2 Reagent Strips (K972706) read by Clinitek Status Analyzer (K031947)." This is a common method for demonstrating substantial equivalence for in vitro diagnostic (IVD) devices.
For the precision study, control solutions (Level 1, Level 2, Level 3) with defined target concentrations were used as ground truth.
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 models. Given that the device is a reflectance photometer, its "training" would involve calibration and optimization during its development. This document focuses on the validation of the finished product. Therefore, no sample size for an AI/ML training set is provided.
9. How the Ground Truth for the Training Set was Established
As no specific "training set" in the AI/ML sense is mentioned, this question is not directly applicable. For the precision and accuracy studies, the ground truth was established as described in points 3 and 7. The device's internal calibration would have been established by the manufacturer during its development using reference materials and established laboratory methods.
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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
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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
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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 | ProductCode | Description | CommonName |
|---|---|---|---|---|
| Mission® U120 UltraUrine Analyzer | 862.2900Class I | KQO | AutomatedUrinalysisSystem | UrineChemistryAnalyzer |
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| Mission® UrinalysisReagent Strips(Microalbumin/Creatinine) | 862.1645 –Class I862.1225 –Class II | JIRJFY | UrinalysisReagent Strips | UrinalysisReagentStrips |
|---|---|---|---|---|
| Mission® Liquid UrineControls, Mission®Liquid Diptube UrineControls | 862.1660Class I | JJW | Quality controlmaterial(assayed andunassayed) | UrinalysisControls(AssayedAndUnassayed) |
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 < 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).
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/hourContinuous Test Mode: 120 tests/hour |
| Memory | Last 2000 results |
| Strip Incubation Time | 1 minute |
| PC Port | USB (data communications);(Not connect to PC)Bluetooth WirelessStandard RS232C Port |
| Capabilities | Internal thermal printerBarcode reader ConnectorExternal 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 powersupply |
| 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 UrineAnalyzer | Clinitek Status Analyzer(K031947) |
|---|---|---|
| Similarities | ||
| Methodology | Reflectance Photometer | Reflectance Photometer |
| Principle | The U120 Ultra Urine Analyzermeasures the intensity of the lightreflected from the reagent areas ofa urinalysis reagent strip. | The Clinitek Status Analyzermeasures the intensity of thelight reflected from the reagentareas of a urinalysis reagentstrip. |
| Parameters Detected | Albumin and Creatinine | Albumin and Creatinine |
| Calculated Parameters | Albumin: Creatinine Ratio | Albumin: Creatinine Ratio |
| Available Languages onScreen | English and Spanish | English and Spanish |
| Line Leakage Current | <0.5mA | <0.5mA |
| Power Source | 100- 240 VAC(adapter), (50-60Hz± 1HZ)6 AA batteries with 100 tests/6new batteries; | Input 100-240V ± 20% and45-65 Hz, output + 9V; Batterypowered operation (optional) 6AA non-rechargeable alkalinebatteries |
| User Interface | Touch Screen based UI | Touch Screen based UI |
| Weight | ≤1.66 kg (3.65 lbs.) withoutbatteries or power supply | 1.66 kg (3.65 lbs.) |
| Differences | ||
| Detection | The Mission® U120 Ultra UrineAnalyzer utilizes a CMOS imagesensor to measure the intensity oflight. The frequency of the light isdetermined by the LED lightsource. | The Clinitek Status Analyzerutilizes a CCD (charge coupleddevice) to measure the intensityof light. The frequency of thelight is determined by the LEDlight source. |
| Chemistry | Mission® Urinalysis ReagentStrips (Microalbumin/ Creatinine) | CLINITEK MicroalbuminReagent Strips (K972706) |
| Memory | Last 2000 results | Last 200 results |
| PC Port | Standard RS232C Port (cable notincluded),USB Port (cable not included);(Not connect to PC)Bluetooth Wireless | Bidirectional RS232 serialport with standard cable forhooking up to the computer |
| Capabilities | Internal thermal printerBarcode reader ConnectorExternal printer (optional)Barcode reader (optional)RJ45 Ethernet; (optional) | Internal printer (included)External printer (not included)9-Pin Parallel External PrinterPort (included) |
| Analyzer OperatingConditions | 0-40°C (32-104°F); ≤85% RelativeHumidity (non-condensing) | 5-40°C (41-104°F); 20%-80%Relative Humidity (non-condensing) |
| Optimum OperatingConditions | 15-30°C (59-86°F); 20-80%Relative Humidity (non-condensing) | 18-30°C (64-86°F) 20-80%Relative Humidity (non-condensing) |
| Dimensions (L X W X H) | 26.0 (L) x 15.0 (W) x 17.5 (H) cm | 27.2 (L) x 17.1 (W) x 15.8 (H)cm |
| Display Dimensions (L XW) | Large touch screen Color LCDTFT 640x480,11.7 (W) x 8.8 (H) cm | 27.2 (L) x 17.1 (W) x 15.8 (H)cm |
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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) |
|---|---|---|
| Similarities | ||
| Indications for Use | The Mission Urinalysis Reagentstrips (Microalbumin/Creatinine)are intended for the semiquantitative measurement ofalbumin and creatinine in urinesamples using the Mission U120Ultra Urine Analyzer. Thesemeasurements are used to assistdiagnosis for kidney function. Itis intended for professional useonly at point-of-care locations. | 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 by the Mission®U120 Ultra Urine Analyzer | The strips are readinstrumentally using theClinitek Status Analyzer(K031947). | |
| Intended Use | Professional use in point-of-careurine testing | Professional use in point-of-careurine testing |
| Target Population | Patients of physicians, hospitals,and clinics | Patients of physicians, hospitals,and clinics |
| Intended Specimen | Urine | Urine |
| Material Provided | Plastic strips affixed with twoseparate reagent areas. | Plastic strips affixed with twoseparate reagent areas. |
| Albumin DetectionMethodology | This test is based on dye bindingusing a high affinitysulfonephthalein dye. At aconstant pH, the development ofany blue color is due to thepresence of albumin. Theresulting color ranges from palegreen to aqua blue | This test is based on dye bindingusing a high affinitysulfonephthalein dye. At aconstant pH, the development ofany blue color is due to thepresence of albumin. Theresulting color ranges from palegreen to aqua blue |
| Creatinine DetectionMethodology | This test is based on theperoxidase-like activity of acopper creatinine complex thatcatalyzes the reaction ofdiisopropylbenzenedihydroperoxide and 3,3',5,5'-tetramethylbenzidine. Theresulting color ranges fromorange through green to blue | This test is based on theperoxidase-like activity of acopper creatinine complex thatcatalyzes the reaction ofdiisopropylbenzenedihydroperoxide and 3,3',5,5'-tetramethylbenzidine. Theresulting color ranges fromorange through green to blue |
| Detection Range | Detects albumin between 10-150mg/LDetects creatinine between10-300 mg/dL (0.9 -26.5 mmol/L) | Detects albumin between 10-150mg/LDetects creatinine between10-300 mg/dL (0.9 -26.5mmol/L) |
| Differences | ||
| Storage | 2 to 30°C | 15 to 30°C |
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Characteristic of the Mission® Liquid Urine Controls and Mission® Liquid Diptube Urine Controls are compared with the Biorad Liquicheck Urinalysis control (K070848) in the following table:
| Biorad Liquicheck Urinalysiscontrol (K070848) | Mission Liquid Urine Controls(Dropper and Diptube) (K142391) | |
|---|---|---|
| Intended Use | Biorad Liquichek UrinalysisControl is intended for use asassayed quality control urine tomonitor the precision ofurinalysis test procedures for theanalytes listed in this packageinsert. | The Mission Liquid Urine Controlsand Mission Liquid Diptube UrineControls are assayed urine controls.intended for use in validating theprecision of analyzer reading ofurinalysis for the Creatinine andAlbumin analytes. |
| Levels | Level-1 and Level-2 | Level-1 and Level-2 |
| Reagent | Liquid form. Prepared fromhuman urine with added humanerythrocytes, simulatedleukocytes, constituents of animalorigin, chemicals, preservativesand stabilizers. | Liquid form. Prepared from bufferwith added chemicals, preservativesand stabilizers. |
| Storage | 2~8°C | 2~8°C |
| Shelf life | The product is stable until theexpired date when storedunopened at 2~8°C. All analyteswill be stable for 30days at 2 to25°C | Unopened controls are stable untilthe expiration date printed on thebottle label when stored at 2-8°C(36-46°F).All analytes are stable for 30 daysat 15-30°C (59-86°F) or until theexpiration date at 2-8°C (36-46°F)once opened and stored with thecap on tightly. |
| Analytes | BilirubinBloodCastsClarityColorCreatinineCrystalsGlucosehCGKetonesLeukocytesMicroalbuminNitriteOsmolalitypHProtein TotalProtein-to-Creatinine RatioRBCSpecific GravityUrobilinogenWhite Blood cells | CreatinineMicroalbumin |
| Assignment ofvalues | The results printed in the insertwere derived from replicateanalyses and are specific for this | Expected values were obtainedfrom replicate analysis using threelots of Mission® Urinalysis |
| lot of product. The tests listed | Reagent Strips and three Mission® | |
| were performed | U120 Urine Analyzers for three | |
| by the manufacturer and/or | consecutive days, performed by | |
| independent laboratories using | three operators. | |
| manufacturer supported reagentsand a representative sampling ofthis lot of control. Eachlaboratory should use the resultsprovided only as a reference andestablish its own parameters ofprecision. | Expected values for the Level 1control solution were assigned asALB 10mg/L | |
| CRE 100mg/dL~300mg/dL. |
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Discussion of Clinical Accuracy Tests Performed:
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 results are summarized in the table below:
| Accuracy | Sensitivity | Specificity | |
|---|---|---|---|
| Albumin Results with Mission U120 Ultra | 86.5%(n=429) | 97.6%(n-293) | 92.6%(n=136) |
| Albumin-to-Creatinine Ratio with Mission U120 Ultra | 90.7%(n=429) | 93.1%(n=233) | 94.9%(n=196) |
Discussion of Performance Tests Performed:
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
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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. 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 | False High | N/A |
| Sodium Bicarbonate | 1500 mg/dL | False High | N/A |
| Potassium Chloride | 1500 mg/dL | False Low | N/A |
| Hemoglobin | 10 mg/dL | False High | False High |
| Blood | 0.05% | False High | False High |
Conclusion:
The laboratory testing results and clinical studies demonstrate that the Mission® Urinalysis Reagent Strips (Microalbumin/ Creatinine) read by Mission® U120 Ultra 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.
§ 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.