MISSION U500 URINE ANALYZER
Device Facts
| Record ID | K111221 |
|---|---|
| Device Name | MISSION U500 URINE ANALYZER |
| Applicant | ACON Laboratories, Inc. |
| Product Code | JIO · Hematology |
| Decision Date | Jan 18, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.6550 |
| Device Class | Class 2 |
Intended Use
The Mission® U500 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, Blood, pH, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite. The instrument is intended for prescription, in vitro diagnostic use only. The Mission Urinalysis Reagent Strips are available in different test configurations and 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.
Device Story
Mission® U500 Urine Analyzer is a semi-automated reflectance photometer; analyzes intensity/color of light reflected from Mission Urinalysis Reagent Strips. Input: urine-impregnated reagent strips; Output: semi-quantitative/qualitative results for 11 analytes. Used in clinical settings; operated by healthcare professionals. Throughput 500 tests/hour; 7-second measuring cycle. Stores 2,000 patient records; prints results via internal/external printer. Benefits: rapid, automated screening for metabolic/systemic diseases; aids diagnosis/monitoring of kidney/urinary tract disorders.
Clinical Evidence
Method comparison study between Mission® U500 and ACON U120 predicate. Evaluated percent positive agreement, percent negative agreement, and agreement on/between color blocks. Results demonstrate comparable testing performance between subject and predicate devices. Analytical performance studies included sensitivity, detection range, reproducibility, interfering substances, and environmental stress testing (temperature, humidity, voltage).
Technological Characteristics
Reflectance photometer; uses photosensitive diodes. Wavelengths: 525 nm and 635 nm. Power: 100-240 VAC. Connectivity: RS232C port, parallel printer port. Dimensions: 35.5 x 27.4 x 19.5 cm. Weight: 4.0 kg. Automatic calibration. Throughput: 500 tests/hour. Strip incubation: 1 minute.
Indications for Use
Indicated for prescription, in vitro diagnostic use in clinical settings for semi-quantitative or qualitative detection of urine analytes (Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, Ascorbic Acid, Nitrite) to aid in diagnosis/monitoring of metabolic, systemic, or urinary tract diseases.
Regulatory Classification
Identification
An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)
Special Controls
*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Predicate Devices
- ACON U120 Urine Analyzer (k070929)
Related Devices
- K983510 — CHEMSTRIP 101 URINE ANALYZER · Boehringer Mannheim Corp. · Oct 27, 1998
- K061812 — COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 · Analyticon Biotechnologies AG · Apr 6, 2007
- K031947 — BAYER CLINITEK STATUS ANALYZER · Bayer Healthcare, LLC · Dec 19, 2003
Submission Summary (Full Text)
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# 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 K /// 22 |
## Submitter's Identification:
ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, CA 92121
Tel.: 858-875-8011 Fax: 858-875-8099
Date Prepared: December 29, 2011
#### Contact Person:
Xie Qiyi Sr. Staff, Regulatory and Clinical affairs
#### Proprietary Name of the Device:
Mission® U500 Urine Analyzer
## Common Name:
Urine Chemistry Analyzer
## Regulation Section and Classification:
| 21 CFR § 862.2900 | Automated Urinalysis System |
|-------------------|---------------------------------------------------------------------|
| 21 CFR § 862.1340 | Urinary Glucose (Non-Quantitative) Test System |
| 21 CFR § 864.6550 | Occult Blood Test |
| 21 CFR § 862.1115 | Urinary Bilirubin and its Conjugates (Non-Quantitative) Test System |
| 21 CFR § 862.1435 | Ketones (Non-Quantitative) Test System |
| 21 CFR § 862.1550 | Urinary pH (Non-Quantitative) Test System |
| 21 CFR § 862.1645 | Urinary Protein or Albumin (Non-Quantitative) Test System |
| 21 CFR § 862.1785 | Urinary Urobilinogen (Non-Quantitative) Test System |
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21 CFR § 862.1510 Nitrite (Non-Quantitative) Test System
21 CFR & 864.7675 Leukocyte Peroxidase Test
Ascorbic Acid Test System 21 CFR & 862.1095
21 CFR § 862.2800 Refractometer for Clinical Use
- Class I: Automated Urinalysis System; Urinary Leukocytes, Urinary pH, Nitrite, Urinary Protein. Ketones. Urinary Urobilinogen, Urinary Bilirubin, Specific Gravity and Ascorbic Acid
Class II: Urinary Glucose and Occult Blood
## Product Code:
- KQO Automated Urinalysis System
- Urinary Glucose (non-quant.) test system JIL
- Blood, Occult, Colorimetric, in urine JIO
- LJX Test. Urine Leukocyte
- CEN Urinary, pH (non-quant.)
- Nitrite (urinary, non-quant.) test system JMT
- Protein or Albumin (urinary, non-quant.) test system JIR
- Ketones (urinary, non-quant.) test system JIN
- CDM Urinary Urobilinogen (non-quant.) test system
- JJB Urinary Bilirubin & its conjugates (urinary, non-quant.) test system
- JMA Acid. Ascorbic. 2. 4-Dinitrophenylhydrazine (Spectrophotometric)
- JRE Refractometer clinical use
# Medical Specialty:
Clinical Chemistry
# Predicate Device:
ACON U120 Urine Analyzer, ACON Laboratories, Inc. marketed by ACON laboratories, Inc located at 10125 Mesa Rim Road, San Diego, CA 92121, USA.
510(k) Number: K070929
### Description:
The Mission® U500 Urine Analyzer is a semi-automated reflectance photometer in conjunction with Mission Urinalysis Reagent Strips (originally cleared under k061559) that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip. The analyzer throughput is 500 tests per hour and the measuring cycle is 7 seconds per test. The analyzer stores up to 2,000 patient records and prints the results in Conventional, SI, or Arbitrary units using an integrated internal or external printer.
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Test Format and Configurations:
- Mission® U500 Urine Analyzer, 1 Strip Platform/Waste Tray, 2 Printer Paper l) Rolls, 2 Fuses, 1 Power Cord, 1 Instruction Manual;
- 2) Mission® U500 Urine Analyzer, 1 Strip Platform/Waste Tray, 2 Printer Paper Rolls, 1 Barcode Reader, 1 Serial Splitter Cable, 2 Fuses, 1 Power Cord, 1 Instruction Manual
The following components are available separately: Printer Paper Rolls, Barcode Reader, Data Transfer Kit, and Fuses.
| # of<br>Parameters | Catalog<br>No. | Type of<br>Strip | Analytes |
|--------------------|----------------|------------------|-----------------------------------------------------------------------------------------------------------------------------|
| 8 | U031-081 | 8N | Leukocytes, Nitrite, Protein, pH, Blood, Specific Gravity,<br>Ketone and Glucose |
| 9 | U031-091 | 9U | Nitrite, Urobilinogen, Protein, pH, Blood, Specific<br>Gravity, Ketone, Bilirubin and Glucose |
| 10 | U031-101 | 10U | Leukocytes, Nitrite, Urobilinogen, Protein, pH, Blood,<br>Specific Gravity, Ketone, Bilirubin and Glucose |
| 11 | U031-111 | 11A | Leukocytes, Nitrite, Urobilinogen, Protein, pH, Blood,<br>Specific Gravity, Ketone, Bilirubin, Glucose and Ascorbic<br>Acid |
Compatible Urinalysis Reagent Strips (default):
Note: Only use strips of the same brand as the analyzer to ensure proper function and accurate results.
Above configurations shown for 8 through 11 parameters are available as options. Other compatible strip configurations are available with combinations between 1 and 11 parameters from the label below, as defined in the analyzer selectable strip configuration settings. The strip configuration is factory-fixed for each analyzer and is reflected in the user manual.
#### Analyzer-read Strips: xx/xx/xx/xx
The Mission Urinalysis Reagent Strips have been cleared for visually reading by comparison to a color chart and the Mission Urinalysis Reagent Strips can be sold in any combination of 1 or more of the following 11 analytes (k061559).
| Glucose | Bilirubin |
|------------------|---------------|
| Ketone | Urobilinogen |
| Specific Gravity | Nitrite |
| Blood | Leukocyte |
| pH | Ascorbic Acid |
| Protein | |
Combination from the 11 parameters can be read on the Mission U500 Urine Analyzer (Catalog # U211-111, U211-101). The following list shows current combinations, additional combinations can be available based on customer request.
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| Product Name | No. of<br>Parameters | Type of Strip | Analytes |
|-------------------------------------------|----------------------|---------------|--------------------------------------------------------------------------------------------------------------------------|
| Mission® Urine Analysis Strip<br>U031-111 | 11 | 11A | Leukocytes, Nitrite, Urobilinogen, Protein, pH, Blood, Specific<br>Gravity, Ketone, Bilirubin, Glucose and Ascorbic Acid |
| Mission® Urine Analysis Strip<br>U031-101 | 10 | 10U | Leukocytes, Nitrite, Urobilinogen, Protein, pH, Blood, Specific<br>Gravity, Ketone, Bilirubin and Glucose |
| | | 10A | Ascorbic Acid, Glucose, Bilirubin, Ketone, Specific Gravity,<br>Blood, pH, Protein, Urobilinogen, Nitrite |
| Mission® Urine Analysis Strip<br>U031-091 | 9 | 9U | Nitrite, Urobilinogen, Protein, pH, Blood, Specific Gravity,<br>Ketone, Bilirubin and Glucose |
| Mission® Urine Analysis Strip<br>U031-081 | 8 | 8U | Glucose, Bilirubin, Ketone, Blood, pH, Protein, Urobilinogen,<br>Nitrite |
| | | 8N | Leukocytes, Nitrite, Protein, pH, Blood, Specific Gravity,<br>Ketone and Glucose |
| | | 8S | Glucose, Specific Gravity, Blood, pH, Protein, Urobilinogen,<br>Nitrite, Leukocytes |
| | | 8K | pH, Glucose, Bilirubin, Protein, Urobilinogen , Nitrite,<br>Leukocytes, Ketone |
| Mission® Urine Analysis Strip<br>U031-071 | 7 | 7N | Glucose, Ketone, Blood, pH, Protein, Nitrite, Leukocytes |
| Mission® Urine Analysis Strip<br>U031-061 | 6 | 6NE | Glucose, Blood, pH, Protein, Nitrite, Leukocytes |
| | | 6UE | Bilirubin, Specific Gravity, Blood, Protein, Urobilinogen,<br>Nitrite |
| Mission® Urine Analysis Strip<br>U031-051 | 5 | 5BE | Glucose, Ketone, Blood, pH, Protein |
| | | 5NE | Glucose, Blood, Protein, Nitrite, Leukocytes |
| | | 5SE | Glucose, Specific Gravity, Blood, pH, Protein |
| | | 5UE | Bilirubin, Blood, Urobilinogen, Nitrite, Leukocytes |
| | | | 4SE |
| Mission® Urine Analysis Strip<br>U031-141 | 4 | 4BE | Glucose, Blood, pH, Protein |
| | | 4KE | Glucose, Ketone, pH, Protein |
| | | 4GE | Glucose, Blood, Protein, Leukocytes |
| | | 4NE | Blood, Protein, Nitrite, Leukocytes |
| | | 4PE | Glucose, Protein, Nitrite, Leukocytes |
| | | | 3PE |
| Mission® Urine Analysis Strip<br>U031-031 | 3 | 3KE | Glucose, Ketone, Protein |
| | | 3GE | Glucose, Ketone, pH |
| | | 3NE | Blood, Nitrite, Leukocytes |
| | | | 2GE |
| Mission® Urine Analysis Strip<br>U031-021 | 2 | 2KE | Glucose, Ketone |
| | | 2NE | Nitrite, Leukocytes |
| | | 2BE | Blood, Leukocytes |
| | | 2UE | Bilirubin, Urobilinogen |
| | | | 2SE |
| Mission® Urine Analysis Strip<br>U031-011 | 1 | 1BE | Blood |
| | | 1PE | pH |
| | | 1GE | Glucose |
| | | 1KE | Ketone |
| | | | 1RE |
# Additional Compatible Mission® Urinalysis Reagent Strips
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#### Intended Use:
The Mission® U500 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, Blood, pH, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection Nitrite. The instrument is intended for prescription, for in vitro diagnostic use only. Mission Urinalysis Reagent Strips are available in different test configurations and 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.
| Feature | Specifications |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Intend of use | For Prescription, In Vitro Diagnostic Use Only |
| Testing Specimen | Urine |
| Detection | Photosensitive diode |
| Detection Methodology | Reflectance Photometer |
| Wavelength | 525 nm and 635 nm (nominal) |
| Analyzer Operation Conditions | 0-40°C (32-104°F); ≤85% Relative Humidity (non-condensing) |
| Strips to be used | Mission® Urinalysis Reagent Strips |
| Strip Operating Conditions | 15-30°C (59-86°F); ≤85% Relative Humidity (non-condensing) |
| Calibration | Automatic |
| Power Source | 100-240 VAC, 50-60 Hz |
| Line Leakage Current | <3.5 mA (single fault) |
| Data Transfer | Standard RS232C Port |
| Capabilities | Internal printer (included)<br>25 Pin Parallel External Printer Port connector (included)<br>Barcode Reader (optional) |
| Available Languages on Screen | English(default), Spanish, French (others as installed) |
| Throughput | 500 tests/hour |
| Measuring Cycle | 7 seconds/test |
| Strip Incubation Time | 1 minute |
| Memory | 2,000 results |
| Waste Disposal Capacity | Up to 150 strips |
| Dimensions | 35.5 cm x 27.4 cm x 19.5 cm (14" x 10.8" x 7.7") |
| Display Dimensions | 11.5 cm x 9.0 cm (4.5" x 3.5") |
| Weight | 4.0 kg (8.82 lbs) |
#### Technological Characteristics:
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# Comparison to Predicate Devices:
The Mission® U500 Urine Analyzer is substantially equivalent to the ACON U120 Urine Analyzer originally cleared under k070929.
| Feature | Mission® U500 Urine Analyzer | ACON U120 Urine Analyzer<br>(k070929) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Similarities | | |
| Intend of use | For Prescription, In Vitro<br>Diagnostic Use Only | Same |
| Testing Specimen | Urine | Same |
| Detection | Photosensitive diode | Same |
| Detection Methodology | Reflectance Photometer | Same |
| Wavelength | 525 nm and 635 nm (nominal) | Same |
| Analyzer Operation<br>Conditions | 0-40°C (32-104°F); ≤85% Relative<br>Humidity (non-condensing) | Same |
| Strips to be used | Mission® Urinalysis Reagent Strips | Same |
| Strip Operating Conditions | 15-30°C (59-86°F); ≤85% Relative<br>Humidity (non-condensing) | Same |
| Strip Incubation Time | 1 minute | Same |
| Calibration | Automatic | Same |
| Power Source | 100-240 VAC, 50-60 Hz | Same |
| Line Leakage Current | <3.5 mA (single fault) | Same |
| Data Transfer | Standard RS232C Port | Same |
| Capabilities | Internal printer (included)<br>25 Pin Parallel External Printer Port<br>connector (included)<br>Barcode Reader (optional) | Same |
| Available Languages on<br>Screen | English(default), Spanish, French<br>(others as installed) | Same |
| Differences | | |
| Throughput | 500 tests/hour | Single Test Mode: 40<br>tests/hour, Continuous Test<br>Mode: 120 test/hour |
| Measuring Cycle | 7 seconds/test | 20 seconds/test |
| Memory | 2,000 results | Last 500 results |
| Waste Disposal Capacity | Up to 150 strips | Manually at each test |
| Dimensions | 14"(L) x 10.8"(W) x 7.7"(H)<br>(35.5 x 27.4 x 19.5)cm | 10.7"(L) x 10.4"(W) x 5.8"(H)<br>(27.1 x 26.5 x 14.8) cm |
| Display Dimensions | 4.5"(W) x 3.5" (H)<br>(11.5 × 9.0) cm | 4.2"(W) x 1.1"(H)<br>(10.6 x 2.8) cm |
| Weight | 8.82 lbs (4.0 kg) | 5.73 lbs (2.6 kg ) |
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#### Summarv of Performance Data:
Performance studies were conducted in-house and in a clinical setting to establish the performance of the Mission® Urine Analyzer and to demonstrate substantial equivalence to the predicate device. Analytical performance studies are summarized below. In addition, software documentation and a summary of electromagnetic compatibility and electrical safety testing are included to provide additional evidence of device performance.
#### Analytical Performance Testing:
The performance characteristics of the Mission® Urine Analyzer were evaluated by the following studies: analytical sensitivity and detection range, reproducibility, interfering substances, temperature flex, humidity flex, voltage flex, and reagent strip stability.
#### Clinical Performance Testing:
Clinical performance of the Mission® U500 Urine Analyzer was evaluated in a method comparison study between the Mission® U500 Urine Analyzer and ACON U120 Urine Analyzer predicate device. Clinical study data are presented for the percent positive agreement, percent negative agreement, and percent agreement on and between color blocks results indicate that the intended users were able to obtain comparable testing results when using the Mission® U500 Urine Analyzer and the legally marketed ACON U120 Urine Analyzer both in conjuction with the Mission® Urine Analysis Reagent Strips (originally cleared under k061559).
#### Conclusion:
The nonclinical and clinical performance study results demonstrate that the Mission® U500 Urine Analyzer, as designed and manufactured, is substantially equivalent to the predicate device Mission® U120 Urine Analyzer (originally cleared under k070929).
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling the image. The HHS logo is a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side of the seal.
10903 New Hampshire Avenue Silver Spring, MD 20993
ACON LABORATORIES, INC c/o Qiyi Xie 10125 Mesa Rim Rd San Diego, CA 92121
JAN 1 8 2012
Re: k111221
Trade Name: Mission U500 Urine Analyzer Regulation Number: 21 CFR §864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Proguct Codes: J10, JIL, CDM, JJB, JIN, JIR, NGJ, LJX, CEN, JMA, JRE, KQO Dated: December 29, 2011 Received: December 30, 2011
Dear Qivi 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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# Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you ucine specific ad view for your cir. Device Evaluation and Safety at (301) 796-5450. Also, contact the regulation entitled, "Misbranding by reference to premarket notification" (2) picase note the regulation regarding postmarket surveillance, please contact CDRH301 CrK Fall 807.77). For questions regarding postmarket Surveillance at (301) Office of Surveillance and Drollier of Societing of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
CI'K I all 805), picaso go to imprimulation 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 Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address (000) 050 2011 01 (01 (0) (2011 01 11:25) Resources for You/Industry/default.htm
Sincerely yours,
V. Ri. D.
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Enclosure
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# Indications for Use Form
510(k) Number (if known): _k111221
Device Name: Mission® U500 Urine Analyzer
Indications for Use:
The Mission® U500 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, Billirubin, Ketone (Acetoacetic acid), romowing Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection Nitrite. The instrument is intended for as won as the in vitro diagnostic use only. Mission Urinalysis Reagent Strips are available in different test configurations and 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.
V Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Q. chala
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
111221 510(k)________________________________________________________________________________________________________________________________________________________________________
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