(243 days)
Not Found
No
The device description explicitly states it is a "reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas". There is no mention of AI, ML, or any form of complex algorithmic processing beyond standard photometric analysis. The performance studies focus on agreement with a predicate device using the same technology.
No.
This device is an in vitro diagnostic device used for semi-quantitative detection of analytes in urine. It aids in diagnosis and monitoring but does not directly treat or provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The instrument is intended for point-of-care, in vitro diagnostic use only." It also mentions that the measurement "aids in the diagnosis and monitoring of metabolic or systemic diseases."
No
The device description explicitly states it is a "reflectance photometer" which is a hardware component used to analyze light reflected from reagent strips. It also mentions "data management and report generation capabilities," which are software functions, but the core function relies on the hardware photometer.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The "Intended Use / Indications for Use" section explicitly states: "The instrument is intended for point-of-care, in vitro diagnostic use only." and "It is intended for professional in vitro diagnostic use only." for the controls.
- Purpose: The device is used to analyze urine samples (an in vitro specimen) to detect various analytes, which aids in the diagnosis and monitoring of diseases. This is a core function of an IVD.
- Device Description: It describes a reflectance photometer that analyzes the color of light reflected from reagent strips, which is a common method used in IVD devices for chemical analysis of biological samples.
- Performance Studies: The document details clinical studies conducted to evaluate the performance of the device in a clinical setting, comparing it to a predicate device. This is a requirement for demonstrating the safety and effectiveness of an IVD.
- Intended User/Care Setting: It specifies "Professional use only. Point-of-care, in vitro diagnostic use only," further reinforcing its IVD classification.
N/A
Intended Use / Indications for Use
The Mission® U120 Ultra Urine Analyzer is intended for use in conjunction with the Mission® Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite.
The instrument is intended for point-of-care, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract. It is intended for professional use only.
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 one or more of the following analytes: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. It is intended for professional in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
JIL, CDM, CEN, JIN, JIO, JIR, JJB, JMT, JRE, LJX, JMA, JJW, KQO
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. Without a urine analyzer, users must visually compare the reagent areas of the strip to a color chart using the naked eye. Mission® U120 Ultra Urine Analyzer also features data management and report generation capabilities.
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.
point-of-care, in vitro diagnostic use only.
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
Clinical studies were conducted using the Mission® U120 Ultra Urine Analyzer and Mission® Urinalysis Reagent strips. The purpose of the study was to evaluate the performance of Mission® Urinalysis Reagent strip read by Mission® U120 Ultra Urine Analyzer compared to the predicate: Mission® Urinalysis Reagent strip read by ACON U120 Urine Analyzer (K070929); and to observe if there is any problem/issue with operation of the Mission® Urinalysis Reagent strip / Mission® U120 Ultra Urine Analyzer when they are placed in the hands of the intended user.
Approximately 120 patient urine specimens were randomly collected from patients at each of 3 clinical sites, and tested by 3 intended users at each site (total of 9 users for all 3 sites) Each specimen was tested by Mission® Urinalysis Reagent strip read with Mission® U120 Ultra Urine Analyzers and Mission® Urinalysis Reagent strip read with Mission® U120 Urine Analyzers. Each intended user tested approximately the same number of specimens at each site. The study period at each site last over 3 months. In order to evaluate the performance with the analyte covering the measuring range, few contrived urine specimens were tested at each site following the study protocol.
Additional study was carried out at 2 sites in US; a POC site and a specialty care office for inclusion of positive samples for the Nitrite, Urobilinogen, Ketone and Bilirubin analytes.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study:
Sample Size: Approximately 120 patient urine specimens from each of 3 clinical sites (total 360 patient samples), including contrived samples for some analytes.
Study Type: Comparative study of Mission® U120 Ultra vs Mission® U120 Urine Analyzer using Mission® Urinalysis Reagent Strips.
Key Results:
- Leukocyte: 95.3% exact agreement (446/468), 100% within one level agreement (468/468)
- Nitrite: 100% exact agreement (451/451), 100% within one level agreement (451/451)
- Urobilinogen (Uro): 93.4% exact agreement (398/426), 100% within one level agreement (426/426)
- Protein (Pro): 92.7% exact agreement (434/468), 100% within one level agreement (468/468)
- pH: 86.8% exact agreement (406/468), 100% within one level agreement (468/468)
- Blood (Blo): 93.8% exact agreement (439/468), 100% within one level agreement (468/468)
- Specific Gravity (SG): 85.5% exact agreement (400/468), 100% within one level agreement (468/468)
- Ketone: 96.4% exact agreement (446/458), 100% within one level agreement (458/458)
- Bilirubin (Bil): 97.4% exact agreement (444/450), 100% within one level agreement (450/450)
- Glucose (Glu): 95.7% exact agreement (448/468), 100% within one level agreement (468/468)
- Ascorbic Acid (ASC): 90.0% exact agreement (421/468), 100% within one level agreement (468/468)
Conclusion: The device is substantially equivalent to the predicate.
Performance Tests:
- Precision Study: Evaluated reproducibility using 3 levels of control solutions with Mission® U120 Ultra Urine Analyzer and Mission® Urinalysis Reagent Strips.
- Sample Size: 160 strips for each concentration (2 strips x 2 runs x 20 days x 2 operators).
- Key Result: 100% exact agreement for all analytes across all 3 levels of control.
- Second Precision Study:
- Sample Size: 180 strips for each concentration (20 strips x 3 lots x 3 analyzers/operators x 1 day).
- Key Result: 100% exact agreement for all analytes across all 3 levels of control.
- Sensitivity Study: Determined low and high end sensitivity for combined Mission® Urinalysis Reagent Strips and Mission® U120 Ultra Urine Analyzer. (Specific values in table provided in source document).
- Interference Study: Evaluated effects of common interfering substances.
- Temperature Flex Study: Validated optimal temperature range (2°C to 45°C) for testing, 5 replicates per sample.
- Humidity Flex Study: Tested strip stability in different humidity environments (Specific values in table provided in source document).
- Voltage Flex Study: Performed using control solutions with different voltages (86V, 100V, 264V, 220V baseline). Tested three times for each voltage.
- Key Results: Mission® U120 Ultra urine analyzer can operate properly under 86V, 100V and 264V, and the test results are comparable to those of the 220V baseline control results.
- pH Flex Study: Tested sensitivity to pH levels (5 to 9) using normal fresh urine spiked with analytes. 5 replicates were tested for each sample.
- Key Results: Urine pH from 5.0 to 9.0 does not affect the results of Urobilinogen, Ketone, Bilirubin, and Glucose tests. Sample pH>8 would generate false high results on Protein test. Sample pH>9 would generate false high results on Leukocyte and Specific Gravity test, and false low results on Nitrite, Blood, Ascorbic acid test.
- Urine Controls Validation:
- Value Assignment: Tested Level 1 and Level 2 controls using 3 lots of strips and 3 analyzers for 3 consecutive days by 3 operators.
- Stability Studies: Accelerated, Real Time, and Open Stability studies performed.
- Accelerated stability: 24 months at 2-8℃ in unopened bottles.
- Real Time Stability: Shelf life of 24 months.
- Open Canister Stability: Stable for up to 30 days at 15-30°C and 24 months at 2-8°C after opening.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- % Exact Agreement
- % Within one level Agreement
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.
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
§ 862.2900 Automated urinalysis system.
(a)
Identification. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.(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.
0
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ACON LABORATORIES, INC. QIYI XIE SR. STAFF REGULATORY AFFAIRS & CLINICAL AFFAIRS 10125 MESA RIM ROAD SAN DIEGO CA 92121
September 17, 2015
Re: K142543
Trade/Device Name: Mission® Urinalysis Reagent Strips, Mission® Liquid Urine Controls, Mission® Liquid Diptube Urine Controls, Mission® U120 Ultra Urine Analyzer Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: II Product Code: JIL, CDM, CEN, JIN, JIO, JIR, JJB, JMT, JRE, LJX, JMA, JJW, KQO Dated: March 25, 2015 Received: March 26, 2015
Dear Qiyi Xie:
This letter corrects our substantially equivalent letter of May 11, 2015.
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
1
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.
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,
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
2
Indications for Use
510(k) Number (if known) K142543
Device Name
Mission® Urinalysis Reagent Strips Mission® U120 Ultra Urine Analyzer Mission® Liquid Urine Controls, Mission® Liquid Diptube Urine Controls
Indications for Use (Describe)
The Mission® U120 Ultra Urine Analyzer is intended for use in conjunction with the Mission® Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite.
The instrument is intended for point-of-care, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract. It is intended for professional use only.
The Mission® Liquid Urine Controls Liquid Diptube Urine Controls are assayed urine controls, intended for use in validating the precision of analyzer reading of urinalysis for one or more of the following analytes: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. It is intended for professional in vitro diagnostic use only.
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) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 K142543
Submitter's Identification:
ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, California 92121 Tel.: 858-875-8019 Fax: 858-875-8011
Date Prepared: May 11, 2015
Contact Person:
Qiyi Xie Senior Staff, Clinical & Regulatory Affairs Email: qxie@aconlabs.com
Proprietary Name of the Device:
Mission® Urinalysis Reagent Strips Mission® U120 Ultra Urine Analyzer Mission® Liquid Urine Controls Mission® Liquid Diptube Urine Controls
Common Name:
Urine Chemistry Analyzer Urinalysis Controls (Assayed and Unassayed)
Classification Name:
Class II §21 CFR § 862.1340 Urinary Glucose (Non-Quantitative) Test System
Class I §21 CFR 862.2900, Automated Urinalysis System
Class I, reserved §21 CFR 862.1660, Quality control material (assayed and unassayed)
4
Predicate Device:
ACON Urinalysis Reagent Strips, ACON U120 Urine Analyzer ACON Laboratories Inc. 10125 Mesa Rim Road San Diego, CA 92121 510(k) Number: K070929
Mission Liquid Urine Control, Mission Liquid Diptube Urine Control ACON Laboratories Inc. 10125 Mesa Rim Road San Diego, CA 92121 510(k) Number: K103387
Device Name: Mission® Urinalysis Reagent Strips, Mission® U120 Ultra Urine Analyzer Mission® Liquid Urine Controls, Mission® Liquid Diptube Urine Controls
| Regulation Description | Product
Code | Device
Class | Regulation |
|-------------------------------------------------------------------------|-----------------|-----------------|-------------------|
| Occult blood test | JIO | II | 21 CFR § 864.6550 |
| Urinary glucose (non-quantitative) test system | JIL | II | 21 CFR § 862.1340 |
| Urinary protein or albumin (non-quantitative)
test system | JIR | I | 21 CFR § 862.1645 |
| Urinary bilirubin and its conjugates (non-
quantitative) test system | JJB | I | 21 CFR § 862.1115 |
| Ketones (non-quantitative) test system | JIN | I | 21 CFR § 862.1435 |
| Leukocyte peroxidase test | LJX | I | 21 CFR § 864.7675 |
| Nitrite (non-quantitative) test system | JMT | I | 21 CFR § 862.1510 |
| Urinary pH (non-quantitative) test system | CEN | I | 21 CFR § 862.1550 |
| Refractometer for clinical use (specific
gravity) | JRE | I | 21 CFR § 862.2800 |
| Urinary urobilinogen (non-quantitative) test
system | CDM | I | 21 CFR § 862.1785 |
| Ascorbic acid test system | JMA | I | 21 CFR § 862.1095 |
| Quality control material (assayed and
unassayed) | JJW | I,
reserved | 21 CFR § 862.1660 |
| Automated urinalysis system | KQO | I | 21 CFR § 862.2900 |
5
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. Without a urine analyzer, users must visually compare the reagent areas of the strip to a color chart using the naked eye. Mission® U120 Ultra Urine Analyzer also features data management and report generation capabilities.
Intended Use:
The Mission® U120 Ultra Urine Analyzer is intended for use in conjunction with the Mission® Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic Acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite.
The instrument is intended for point-of-care, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract. It is intended for professional use only.
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 one or more of the following analytes: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes. It is intended for professional in vitro diagnostic use only.
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.
6
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 following analytes: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes.
| Feature | Mission® U120 Ultra Urine Analyzer |
|---|---|
| Methodology | Reflectance Photometer |
| Detection | CMOS Image Sensor |
| Chemistry | Mission® Urinalysis Reagent Strips |
| 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). (50-60Hz) |
Technological Characteristics:
7
| 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") | |
| 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 Urinalysis Reagent Strips and the Ultra Urine Analyzer is substantially equivalent to the ACON Urinalysis Reagent Strips and the ACON U120 Urine Analyzer (K070929):
| Item | Mission® Urinalysis Reagent Strips,
Mission® U120 Ultra Urine Analyzer,
Candidate Device | ACON Urinalysis Reagent Strips,
ACON U120 Urine Analyzer,
Predicate |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Methodology | Reflectance Photometer | Reflectance Photometer |
| Principle | The U120 Urine Analyzer
measures the intensity of the light
reflected from the reagent areas
of a urinalysis reagent strip. | The U120 Ultra Urine
Analyzer measures the
intensity of the light reflected
from the reagent areas of a
urinalysis reagent strip. |
| Chemistry | Mission® Urinalysis Reagent
Strips | Mission® Urinalysis Reagent
Strips |
| Analytes Detected | Leukocytes, Nitrite, blood
(Occult), Glucose, Protein,
Ketone, Specific Gravity, pH,
Bilirubin, Urobilinogen and
Ascorbic Acid | Leukocytes, Nitrite, blood
(Occult), Glucose, Protein,
Ketone, Specific Gravity, pH,
Bilirubin, Urobilinogen and
Ascorbic Acid |
| Strip Incubation
Time | 1 minute | 1 minute |
| Available
Languages on
Screen | English and Spanish | English and Spanish |
| Analyzer
Operating
Conditions | 0-40°C (32-104°F); ≤85%
Relative Humidity (non-
condensing) | 0-40°C (32-104°F); ≤85%
Relative Humidity (non-
condensing) |
| Line Leakage
Current | Differences | | |
| Detection | The ACON U120 Urine Analyzer
utilizes a photodiode to measure
the intensity of light. | The Mission® U120 Ultra
Urine Analyzer utilizes a
CMOS image sensor to
measure the intensity of light. |
| Throughput | Single Test Mode: 60 tests/hour
Continuous Test Mode: 120
tests/hour | Single Test Mode: 55
tests/hour
Continuous Test Mode: 120
tests/hour |
| Memory | Last 500 results | Last 2000 results |
| PC Port | Standard RS232C Port (cable not
included) | Standard RS232C Port (cable
not included),
USB Port (cable not included);
(Not connect to PC)
Bluetooth Wireless |
| Capabilities | Internal heat sensitive printer
(included)
25 Pin Parallel External Printer
Port (not included)
External printer (optional) | Internal thermal printer
Barcode reader Connector
External printer (optional)
Barcode reader (optional)
RJ45 Ethernet; (optional) |
| Power Source | 220 Volts AC (±10%), 50 Hz
(±1),
110 Volts AC (±10%), 60 Hz
(±1),
110-230 Volts AC, 50/60 Hz | 6 AA batteries with 100 tests/6
new batteries; 100- 240
VAC(adapter), (50-60 Hz±
1HZ) |
| Optimum
Operating
Conditions | 15-30°C (59-86°F); ≤75%
Relative Humidity (non-
condensing) | 15-30°C (59-86°F); 20-80%
Relative Humidity (non-
condensing) |
| User Interface | MKB Key based UI | Touch Screen based UI |
| Weight | 2.6 Kg (5.73 lbs.) | ≤1.66 kg (3.65 lbs.) without
batteries or power supply |
| Dimensions (L X
W X H) | 27.1 (L) x 26.5 (W) x 14.6 (H)
cm | 26.0 (L) x 15.0 (W) x 17.5 (H)
cm |
| Display
Dimensions (L X
W) | 240x128 blue and white,
10.6 (W) x 2.8 (H) cm | Large touch screen Color LCD
TFT 640x480,
11.7 (W) x 8.8 (H) cm |
| Appearance | Image: Mission U120 | Image: Mission U120 Ultra |
8
9
Mission® Liquid Urine Controls and Mission® Liquid Diptube Urine Controls are substantially equivalent to ACON's 510k cleared - Mission® Liquid Urine Controls and Mission® Liquid Diptube Urine Controls (K103387)
| Feature | Mission® Liquid Urine Controls,
Mission® Liquid Diptube Urine
Controls | Mission® Liquid Urine
Controls, Mission® Liquid
Diptube Urine Controls
(K103387) |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended/Indications
for Use | For use as an assayed quality
control urine to monitor the
precision of urinalysis test
procedures for the analytes listed
in the package insert.
The Mission® Liquid Urine
Control and Mission® Liquid
Diptube Urine Control are for
use with the Mission® Urinalysis
Reagent Strips and Mission U120
Ultra Urine Analyzer | For use as an assayed quality
control urine to monitor the
precision of urinalysis test
procedures for the analytes
listed in the package insert.
The Mission® Liquid Urine
Control and Mission® Liquid
Diptube Urine Control are for
use with the Mission®
Urinalysis Reagent Strips and
Mission U120 Urine Analyzer
(K070929) |
| Levels | 2 | Same |
| Form | Liquid | Same |
10
| Analytes | Glucose, Bilirubin, Ketone
(Acetoacetic acid), Specific
Gravity, Blood, pH, Protein,
Urobilinogen, Nitrite,
Leukocytes, and Ascorbic Acid | Same |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Storage | 2 to 8°C | Same |
| Matrix | Liquid Matrix Solution | Same |
| Open Vial | 24 months at 2-8°C
30 Days at 15-30°C | Same |
| Packaging
Configuration | Dropper, diptube | Same |
| Shelf Life | 24 months at 2-8°C | Same |
Discussion of Clinical Tests Performed:
Clinical studies were conducted using the Mission® U120 Ultra Urine Analyzer and Mission® Urinalysis Reagent strips. The purpose of the study was to evaluate the performance of Mission® Urinalysis Reagent strip read by Mission® U120 Ultra Urine Analyzer compared to the predicate: Mission® Urinalysis Reagent strip read by ACON U120 Urine Analyzer (K070929); and to observe if there is any problem/issue with operation of the Mission® Urinalysis Reagent strip / Mission® U120 Ultra Urine Analyzer when they are placed in the hands of the intended user.
Approximately 120 patient urine specimens were randomly collected from patients at each of 3 clinical sites, and tested by 3 intended users at each site (total of 9 users for all 3 sites) Each specimen was tested by Mission® Urinalysis Reagent strip read with Mission® U120 Ultra Urine Analyzers and Mission® Urinalysis Reagent strip read with Mission® U120 Urine Analyzers. Each intended user tested approximately the same number of specimens at each site. The study period at each site last over 3 months. In order to evaluate the performance with the analyte covering the measuring range, few contrived urine specimens were tested at each site following the study protocol.
11
Additional study was carried out at 2 sites in US; a POC site and a specialty care office for inclusion of positive samples for the Nitrite, Urobilinogen, Ketone and Bilirubin analytes. Below is the summary of the specimens tested at all sites combined:
| Test | Comparative
Method | N (including
contrived
samples) | % Exact
Agreement | % Within
one level
Agreement |
|-----------|--------------------------------------|---------------------------------------|----------------------|------------------------------------|
| Leukocyte | U120 Ultra vs U120
Urine Analyzer | 468 | 95.3%
(446/468) | 100%
(468/468) |
| Nitrite | U120 Ultra vs U120
Urine Analyzer | 451 | 100%
(451/451) | 100%
(451/451) |
| Uro | U120 Ultra vs U120
Urine Analyzer | 426 | 93.4%
(398/426) | 100%
(426/426) |
| Pro | U120 Ultra vs U120
Urine Analyzer | 468 | 92.7%
(434/468) | 100%
(468/468) |
| pH | U120 Ultra vs U120
Urine Analyzer | 468 | 86.8%
(406/468) | 100%
(468/468) |
| Blo | U120 Ultra vs U120
Urine Analyzer | 468 | 93.8%
(439/468) | 100%
(468/468) |
| SG | U120 Ultra vs U120
Urine Analyzer | 468 | 85.5%
(400/468) | 100%
(468/468) |
| Ketone | U120 Ultra vs U120
Urine Analyzer | 458 | 96.4%
(446/458) | 100%
(458/458) |
| Bil | U120 Ultra vs U120
Urine Analyzer | 450 | 97.4%
(444/450) | 100%
(450/450) |
| Glu | U120 Ultra vs U120
Urine Analyzer | 468 | 95.7%
(448/468) | 100%
(468/468) |
| ASC | U120 Ultra vs U120
Urine Analyzer | 468 | 90.0%
(421/468) | 100%
(468/468) |
These clinical study and statistical data demonstrated that the intended user can follow the product instruction and obtain comparable instrument read results when using the Mission®U120 Ultra Urine Analyzer and a predicate Analyzer. The clinical study results indicate that the Mission®U120 Ultra Urine Analyzer is substantially equivalent to the legally marketed device ACON U120 Urine Analyzer.
Discussion of Performance Tests Performed:
12
The performance characteristics of the Mission® U120 Ultra Urine Analyzer to read Mission® Urinalysis Reagent Strips were verified by Precision study, Interference study, Temperature flex study, voltage flex study, SG flex study, pH 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.
Sensitivity Study:
The sensitivity of the Mission® Urinalysis Reagent Strips was determined in combination of the Mission® U120 Ultra Urine Analyzer. The low and high end range of sensitivity for Mission® Urinalysis Reagent Strips tested by Mission® U120 Ultra is listed in table below.
| Analyte | Color block | Low end sensitivity | High end
sensitivity |
|---------------|-------------|---------------------|-------------------------|
| Ascorbic Acid | 40 mg/dL | 30 mg/dL | >40 mg/dL |
| Ascorbic Acid | 20 mg/dL | 15 mg/dL | 27.5 mg/dL |
| Ascorbic Acid | 10 mg/dL | 5 mg/dL | 13.5 mg/dL |
| Ascorbic Acid | 0 mg/dL | 0 mg/dL | 4.5 mg/dL |
| Glucose | 1000 mg/dL | 750 mg/dL | >1000 mg/dL |
| Glucose | 500 mg/dL | 375 mg/dL | 675 mg/dL |
| Glucose | 250 mg/dL | 192.5 mg/dL | 337.5mg/dL |
| Glucose | 100 mg/dL | 50 mg/dL | 175 mg/dL |
| Glucose | 0 mg/dL | 0 mg/dL | 45mg/dL |
| Bilirubin | 4 mg/dL | 3 mg/dL | >4 mg/dL |
| Bilirubin | 2 mg/dL | 1.5 mg/dL | 2.7 mg/dL |
| Bilirubin | 1 mg/dL | 0.4 mg/dL | 1.35 mg/dL |
| Bilirubin | 0 mg/dL | 0 mg/dL | 0.35 mg/dL |
| Ketone | 80 mg/dL | 60 mg/dL | > 80 mg/dL |
| Ketone | 40 mg/dL | 27.5 mg/dL | 54 mg/dL |
| Ketone | 15 mg/dL | 11 mg/dL | 24.75 mg/dL |
13
| 5 mg/dL | 2.5 mg/dL | 10 mg/dL | |
|---|---|---|---|
| 0 mg/dL | 0 mg/dL | 2.25 mg/dL | |
| Specific Gravity | 1.000~1.030 | 1.000 | 1.030 |
| Blood | 200Ery/µL | 140 Ery/µL | >200 Ery/µL |
| 80 Ery/µL | 52.5 Ery/µL | 126 Ery/µL | |
| 25 Ery/µL | 12.5 Ery/µL | 47.25 Ery/µL | |
| 10 Ery/µL | 5 Ery/µL | 15.75 Ery/µL | |
| 0 Ery/µL | 0 Ery/µL | 4.5 Ery/µL | |
| pH | 5.0~9.0 | 5.0 | 9.0 |
| Protein | 300 mg/dL | 200 mg/dL | >300 mg/dL |
| 100 mg/dL | 65 mg/dL | 180 mg/dL | |
| 30 mg/dL | 22.5 mg/dL | 58.5 mg/dL | |
| 15 mg/dL | 7.5 mg/dL | 20.25 mg/dL | |
| 0 mg/dL | 0 mg/dL | 6.75 mg/dL | |
| Urobilinogen | 8 mg/dL | 6 mg/dL | >8 mg/dL |
| 4 mg/dL | 3 mg/dL | 5.4 mg/dL | |
| 2 mg/dL | 1.5 mg/dL | 2.7 mg/dL | |
| 1 mg/dL | 0.6 mg/dL | 1.35 mg/dL | |
| 0.2mg/dL | 0 mg/dL | 0.54mg/dL | |
| Nitrite | 0.1 mg/dL | 0.05mg/dL | >0.1 mg/dL |
| 0 mg/dL | 0 mg/dL | 0.045 mg/dL | |
| Leukocyte | 500 Leu/µL | 312.5 Leu/µL | >500 Leu/µL |
| 125 Leu/µL | 97.5 Leu/µL | 281.25 Leu/µL | |
| 70 Leu/µL | 42.5 Leu/µL | 87.75 Leu/µL | |
| 15 Leu/µL | 9 Leu/µL | 38.25 Leu/µL | |
| 0 Leu/µL | 0 Leu/µL | 8.25 Leu/µL |
Precision Study:
The reproducibility of the Mission® U120 Ultra Urine Analyzer was evaluated using 3 levels of Control Solutions. The target concentration of the analyte in each control solution was
14
confirmed with Siemens reagent strips read by Clinitek Status urine analyzer and Mission® Urinalysis Reagent Strip read by ACON U120 urine analyzer. Each control solution was tested with one lot of strip in duplicates per run, 2 runs each day by one operator for 20 days. Second operator performed the test following the same protocol with second lot and second analyzer. A total of160 strips were used for each concentration tested (2 strips x 2 run x 20 days x 2 operators= 160 strips). The precision for each device was 100% exact agreement. The results are summarized as below.
| Control | Analyte | Agreement at same block | Agreement within +/- one block |
|---|---|---|---|
| Level 1 | Ascorbic acid | 100% (160/160) | 100% (160/160) |
| Glucose | 100% (160/160) | 100% (160/160) | |
| Bilirubin | 100% (160/160) | 100% (160/160) | |
| Ketone | 100% (160/160) | 100% (160/160) | |
| S.G. | 95.0% (152/160) | 100% (160/160) | |
| Blood | 100% (160/160) | 100% (160/160) | |
| pH | 97.5% (156/160) | 100% (160/160) | |
| Protein | 100% (160/160) | 100% (160/160) | |
| Urobilinogen | 100% (160/160) | 100% (160/160) | |
| Nitrite | 100% (160/160) | 100% (160/160) | |
| Level 2 | Leukocyte | 100% (160/160) | |
| Ascorbic acid | 96.9% (155/160) | 100% (160/160) | |
| Glucose | 98.1% (157/160) | 100% (160/160) | |
| Bilirubin | 97.5% (156/160) | 100% (160/160) | |
| Ketone | 98.1% (157/160) | 100% (160/160) | |
| S.G. | 95.6% (153/160) | 100% (160/160) | |
| Blood | 98.8% (158/160) | 100% (160/160) | |
| pH | 96.9% (155/160) | 100% (160/160) | |
| Protein | 96.9% (155/160) | 100% (160/160) | |
| Urobilinogen | 97.5% (156/160) | 100% (160/160) | |
| Nitrite | 100% (160/160) | 100% (160/160) | |
| Leukocyte | 99.4% (159/160) | 100% (160/160) | |
| Level 3 | Ascorbic acid | 100% (160/160) | 100% (160/160) |
| Glucose | 98.8% (158/160) | 100% (160/160) | |
| Bilirubin | 98.1% (157/160) | 100% (160/160) | |
| Ketone | 96.3% (154/160) | 100% (160/160) | |
| S.G. | 94.4% (151/160) | 100% (160/160) | |
| Blood | 99.4% (159/160) | 100% (160/160) | |
| pH | 98.1% (157/160) | 100% (160/160) | |
| Protein | 100% (160/160) | 100% (160/160) | |
| Urobilinogen | 98.1% (157/160) | 100% (160/160) | |
| Nitrite | 100% (160/160) | 100% (160/160) | |
| Leukocyte | 98.1% (157/160) | 100% (160/160) |
15
Precision Studies were also performed by testing each level of control solution by a single operator in 20 replicates per run per day with each lot on U120 Ultra. Operator 3 followed the same procedure with different lots of strips on different Mission® U120 Ultra Analyzers. A total of 180 strips were used for each concentration tested (20 strips x 3 lots x 3 analyzers (3 operators) x 1day = 180 strips. The precision for each device was 100% exact agreement. The results are summarized as below.
| Control Level | Analyte | Agreement at same block | Agreement within +/- one block | |
|---|---|---|---|---|
| Ascorbic acid | 100% (180/180) | 100% (180/180) | ||
| Glucose100% (180/180)100% (180/180) | ||||
| Bilirubin | 100% (180/180) | 100% (180/180) | ||
| Ketone | 100% (180/180) | 100% (180/180) | ||
| S.G. | 95.6% (172/180) | 100% (180/180) | ||
| Level 1 | Blood | 100% (180/180) | 100% (180/180) | |
| pH | 97.2% (175/180) | 100% (180/180) | ||
| Protein | 100% (180/180) | 100% (180/180) | ||
| Urobilinogen | 100% (180/180) | 100% (180/180) | ||
| Nitrite | 100% (180/180) | 100% (180/180) | ||
| Leukocyte | 100% (180/180) | 100% (180/180) |
16
| Ascorbic acid | 97.8% (176/180) | 100% (180/180) | |
|---|---|---|---|
| Glucose | 96.7% (174/180) | 100% (180/180) | |
| Bilirubin | 97.2% (175/180) | 100% (180/180) | |
| Ketone | 97.2% (175/180) | 100% (180/180) | |
| S.G. | 92.2% (166/180) | 100% (180/180) | |
| Level 2 | Blood | 95.6% (172/180) | 100% (180/180) |
| pH | 93.9% (169/180) | 100% (180/180) | |
| Protein | 97.2% (175/180) | 100% (180/180) | |
| Urobilinogen | 95.5% (172/180) | 100% (180/180) | |
| Nitrite | 100% (180/180) | 100% (180/180) | |
| Leukocyte | 98.3% (177/180) | 100% (180/180) | |
| Ascorbic acid | 98.9% (178/180) | 100% (180/180) | |
| Glucose | 93.3% (168/180) | 100% (180/180) | |
| Bilirubin | 97.2% (175/180) | 100% (180/180) | |
| Ketone | 97.8% (176/180) | 100% (180/180) | |
| S.G. | 97.8% (176/180) | 100% (180/180) | |
| Level 3 | Blood | 96.7% (174/180) | 100% (180/180) |
| pH | 93.9% (169/180) | 100% (180/180) | |
| Protein | 98.9% (178/180) | 100% (180/180) | |
| Urobilinogen | 97.8% (176/180) | 100% (180/180) | |
| Nitrite | 100% (180/180) | 100% (180/180) | |
| Leukocyte | 97.8% (176/180) | 100% (180/180) |
Interference Substances:
The effect of interfering substances commonly found in urine on Mission® Urinalysis Reagent Strips when read by Mission® U120 Ultra Urine Analyzers was studied by preparing 3 levels of controls for each analyte present in the urine and tested with one urine strip on one analyzer following the product insert. Total 3 lots of urine test strips and 3 urine analyzers were used for the study. The following substances were found to interfere with the testing results.
17
| Reagent pad | Interference
substances | Conc. | U120 Ultra analyzer |
|------------------|----------------------------|-------------|-------------------------|
| Glucose | Ascorbic acid | ≥25 mg/dL | False decreased results |
| Glucose | Ketone (Acetoacetate) | ≥100 mg/dL | False decreased results |
| Bilirubin | Ascorbic acid | ≥50 mg/dL | False decreased results |
| Bilirubin | Blood | ≥5% | False increased results |
| Ketone | Blood | ≥5% | False increased results |
| Specific gravity | Protein (Albumin) | ≥300 mg/dL | False increased results |
| Blood | Ascorbic acid | ≥50 mg/dL | False decreased results |
| Urobilinogen | Nitrite | ≥10 mg/dL | False decreased results |
| Protein | Hemoglobin | ≥20 mg/dL | False increased results |
| Protein | Blood | ≥0.05% | False increased results |
| Urobilinogen | Blood | ≥5% | False increased results |
| Nitrite | Ascorbic acid | ≥30 mg/dL | False decreased results |
| Nitrite | Blood | ≥1% | False increased results |
| Leukocyte | Glucose | ≥2000 mg/dL | False decreased results |
| Leukocyte | Blood | ≥0.05% | False increased results |
Temperature Flex Study:
The optimal temperature range for performing the test of Mission® Urinalysis Reagent Strip by Mission® U120 Ultra Urine Analyzer was validated at temperature 2°C to 45°C by performing the test at different temperatures in 5 replicates for each sample.
Humidity Flex Study:
50 strips were stored in different humidity environments and tested with Mission® U120 Ultra Urine Analyzer at different time points. The time that the strips was stable after exposed to the different storage condition is listed in the following table:
| Reagent strips | Humidity of the storage conditions | The time that the strips was stable after
exposed to the different storage
condition |
|------------------|------------------------------------|--------------------------------------------------------------------------------------------|
| Ascorbic acid | 24h |
| | 30-50% | >24h |
| | 60-70% | >24h |
| | >80% | >24h |
| Glucose | 24h |
| | 30-50% | >24h |
| | 60-70% | 8h |
| | >80% | 4h |
| Bilirubin | 24h |
| | 30-50% | >24h |
| | 60-70% | >24h |
| | >80% | >24h |
| Ketone | 24h |
| | 30-50% | 16h |
| | 60-70% | 2h |
| | >80% | 2h |
| Specific Gravity | 24h |
| | 30-50% | >24h |
| | 60-70% | >24h |
| | >80% | >24h |
| Blood | 24h |
| | 30-50% | >24h |
| | 60-70% | 16h |
| | >80% | 4h |
| pH | 24h |
| | 30-50% | >24h |
| | 60-70% | >24h |
| | >80% | >24h |
| Protein | 24h |
| | 30-50% | >24h |
| | 60-70% | >24h |
| | >80% | >24h |
| Urobilinogen | 24h |
| | 30-50% | >24h |
| | 60-70% | >24h |
| | >80% | >24h |
| Nitrite | 24h |
| | 30-50% | 16h |
| | 60-70% | 1h |
| | >80% | 0.5h |
| Leukocyte | 24h |
| | 30-50% | >24h |
| | 60-70% | >24h |
| | >80% | 8h |
18
19
Voltage Flex Study:
The voltage flex study was performed using Mission® Liquid urine control, Level 1(normal) and Level 2 (abnormal) on analyzers supplied with the following voltages: 86V, 100V and 264V. 220V was also tested as the baseline control condition. Three analyzers were turned on using each of the voltage, and tested to see if the analyzer works properly. The analyzers were tested three times under each voltage. Mission® U120 Ultra urine analyzer can operate properly under 86V, 100V and 264V, and the test results are comparable to those of the 220V baseline control results. In conclusion, the range from 86V to 264V is suitable for operation of the Mission® U120 Ultra urine analyzer.
pH Flex Study:
5 normal fresh urines were collected and mixed. The mixed urine was tested with Siemens Clinitek Status and ACON U120 urine analyzer to determine the concentrations in the pooled urine. The Leu, Nit, Uro, Pro, Blo, Ket, Bil, Glu and Asc in the pooled urine were negative with pH at 6.5 and SG at 1.010. The mixed urine samples were split into five aliquots (150 ml / each glass container). Adjust these five aliquots urine pH to 5, 6, 7, 8, 9 with 1M Hydrochloric acid aqueous and 1M Sodium hydroxide aqueous. Then spiked analytes to different concentration as control Level 1, Level 2 and Level 3 listed in the table. The concentrations of each analyte in the control at pH 6 were confirmed with 510(k) cleared Siemens Clinitek Status and U120 urine analyzer, the results were used as expected values. Test these control solutions
20
with Mission® Urinalysis Reagent strips by Mission U120 Ultra analyzer following the product inserts. 5 replicates were tested for each sample.
Sample pH from 5.0 to 9.0 does not affect the results of Urobilinogen, Ketone, Bilirubin, and Glucose tests. Sample pH>8 would generate false high results on Protein test. Sample pH>9 would generate false high results on Leukocyte and Specific Gravity test, and false low results on Nitrite, Blood, Ascorbic acid test.
Urine Controls Validation:
Value Assignment
Control value assignment for the Mission Liquid Urine Control and Mission Liquid Diptube Urine Control was done by testing Level 1 and Level 2 using the Mission Urinalysis Reagent Strips tested on the Mission U120 Ultra Urine analyzer. Three lots of strips and three analyzers were tested for three consecutive days by three operators. All results for level 1 were negative except for SG and pH which should be +/- 2 color blocks of target results and all results for level 2 showed positive results except for ascorbic acid.
Stability Studies
Accelerated, Real Time and Open Stability studies were performed to test the shelf life of Mission Liquid Urine Control and Mission Liquid Diptube Urine Control under different conditions. Accelerated stability study confirmed that the product is stable at 2-8℃ for 24 months when stored properly in unopened bottles. Real Time Stability study confirmed the shelf life of the controls is 24 month. Open Canister Stability study confirmed that the controls remain stable for up to 30 days at 15-30°C and 24months at 2-8°C after being opened.
Conclusion:
The laboratory testing results and clinical studies demonstrate that the Mission® U120 Ultra Urine Analyzer is safe, effective and easy-to-use and such is substantially equivalent to the ACON U120 Urine Analyzer (K070929), currently sold on the U.S. market for professional (point-of-care) testing.