(261 days)
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), 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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Mission® U500 Urine Analyzer:
Acceptance Criteria and Device Performance for Mission® U500 Urine Analyzer
The provided document describes the Mission® U500 Urine Analyzer and its substantial equivalence to a predicate device (ACON U120 Urine Analyzer). While explicit "acceptance criteria" are not presented as a standalone table with numerical targets, the document implicitly defines acceptance based on demonstrating substantial equivalence to the predicate device through analytical and clinical performance.
The "reported device performance" is primarily articulated through the comparison to the predicate device and the conclusion that the new device is "substantially equivalent."
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Analyte | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Overall | Demonstrate performance (sensitivity, range, reproducibility, etc.) comparable to the predicate device. | Evaluated through analytical sensitivity and detection range, reproducibility, interfering substances, temperature flex, humidity flex, voltage flex, and reagent strip stability. (Specific quantitative results not provided in this summary, but the conclusion states these studies demonstrate substantial equivalence). |
| Clinical Performance | ||
| Overall | Clinical results (percent positive agreement, percent negative agreement, percent agreement on and between color blocks) should be comparable to the predicate device when used by intended users. | A method comparison study was conducted between the Mission® U500 Urine Analyzer and the ACON U120 Urine Analyzer. Results for percent positive agreement, percent negative agreement, and percent agreement on and between color blocks indicate that "the intended users were able to obtain comparable testing results." (Specific quantitative results not provided in this summary, but the conclusion states these studies demonstrate substantial equivalence). |
| Technological Characteristics | ||
| Intended Use | Identical to predicate device. | Same |
| Testing Specimen | Identical to predicate device. | Same |
| Detection | Identical to predicate device. | Photosensitive diode (Same) |
| Methodology | Identical to predicate device. | Reflectance Photometer (Same) |
| Wavelength | Identical to predicate device. | 525 nm and 635 nm (nominal) (Same) |
| Operation Cond. | Identical to predicate device. | 0-40°C (32-104°F); ≤85% Relative Humidity (non-condensing) (Same) |
| Strips Used | Mission® Urinalysis Reagent Strips (Same as predicate). | Mission® Urinalysis Reagent Strips (Same) |
| Incubation Time | Identical to predicate device. | 1 minute (Same) |
| Calibration | Automatic (Same as predicate). | Automatic (Same) |
| Power Source | Identical to predicate device. | 100-240 VAC, 50-60 Hz (Same) |
| Data Transfer | Identical to predicate device. | Standard RS232C Port (Same) |
| Capabilities | Internal printer, external printer port, barcode reader (all same as predicate except for integration of internal printer). | Internal printer (included), 25 Pin Parallel External Printer Port connector (included), Barcode Reader (optional) (Similar, internal printer is explicitly included). |
| Languages | Identical to predicate device. | English (default), Spanish, French (others as installed) (Same) |
| Throughput | Improved over predicate device. | 500 tests/hour (Predicate: Single Test Mode: 40 tests/hour, Continuous Test Mode: 120 tests/hour) |
| Measuring Cycle | Improved over predicate device. | 7 seconds/test (Predicate: 20 seconds/test) |
| Memory | Improved over predicate device. | 2,000 results (Predicate: Last 500 results) |
| Waste Diposal | Improved over predicate device. | Up to 150 strips (Predicate: Manually at each test) |
| Dimensions | Different (larger) than predicate device. | 14"(L) x 10.8"(W) x 7.7"(H) (35.5 x 27.4 x 19.5)cm (Predicate: 10.7"(L) x 10.4"(W) x 5.8"(H) (27.1 x 26.5 x 14.8) cm) |
| Display Dim. | Different (larger) than predicate device. | 4.5"(W) x 3.5" (H) (11.5 × 9.0) cm (Predicate: 4.2"(W) x 1.1"(H) (10.6 x 2.8) cm) |
| Weight | Different (heavier) than predicate device. | 8.82 lbs (4.0 kg) (Predicate: 5.73 lbs (2.6 kg)) |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "Clinical study data are presented for the percent positive agreement, percent negative agreement, and percent agreement on and between color blocks," which implies a set of clinical samples were used.
- Data Provenance: The studies were conducted "in-house and in a clinical setting." The document does not specify the country of origin for the clinical data. It also doesn't explicitly state whether the data was retrospective or prospective, though "clinical performance testing" typically implies prospective collection for such comparison studies.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- For this type of device (urine chemistry analyzer reading reagent strips), the "ground truth" would typically refer to a consensus reading by trained, certified clinical laboratory personnel or medical professionals, or possibly reference methods of laboratory analysis, rather than "experts" in the sense of radiologists.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context of human readers improving with or without AI assistance. This device is an automated analyzer, not an AI-assisted diagnostic tool for human readers. The clinical study compares the device's performance to a predicate device's performance.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance: Yes, the entire study effectively serves as a standalone performance evaluation of the "algorithm" (the automated reflectance photometer) as it compares the new device's readings to those of a predicate automated device. The device itself is the algorithm, interpreting the color changes on reagent strips. The "Analytical Performance Testing" and "Clinical Performance Testing" sections describe this.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the clinical comparison was based on comparison to the predicate device (ACON U120 Urine Analyzer). The document states: "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." For the analytical performance, it would involve known concentrations/values of analytes in controlled samples.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable in the context of this device. This device is a reflectance photometer, which relies on a fixed optical and chemical-reaction principle, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its calibration is "Automatic," implying an internal, fixed calibration procedure rather than a learning algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable for the reasons stated above (not an AI/ML algorithm requiring a training set). The calibration of such a device would be established using certified reference materials or standardized solutions with known analyte concentrations.
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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;
-
- 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.
| # ofParameters | CatalogNo. | Type ofStrip | Analytes |
|---|---|---|---|
| 8 | U031-081 | 8N | Leukocytes, Nitrite, Protein, pH, Blood, Specific Gravity,Ketone and Glucose |
| 9 | U031-091 | 9U | Nitrite, Urobilinogen, Protein, pH, Blood, SpecificGravity, Ketone, Bilirubin and Glucose |
| 10 | U031-101 | 10U | Leukocytes, Nitrite, Urobilinogen, Protein, pH, Blood,Specific Gravity, Ketone, Bilirubin and Glucose |
| 11 | U031-111 | 11A | Leukocytes, Nitrite, Urobilinogen, Protein, pH, Blood,Specific Gravity, Ketone, Bilirubin, Glucose and AscorbicAcid |
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. ofParameters | Type of Strip | Analytes |
|---|---|---|---|
| Mission® Urine Analysis StripU031-111 | 11 | 11A | Leukocytes, Nitrite, Urobilinogen, Protein, pH, Blood, SpecificGravity, Ketone, Bilirubin, Glucose and Ascorbic Acid |
| Mission® Urine Analysis StripU031-101 | 10 | 10U | Leukocytes, Nitrite, Urobilinogen, Protein, pH, Blood, SpecificGravity, Ketone, Bilirubin and Glucose |
| 10A | Ascorbic Acid, Glucose, Bilirubin, Ketone, Specific Gravity,Blood, pH, Protein, Urobilinogen, Nitrite | ||
| Mission® Urine Analysis StripU031-091 | 9 | 9U | Nitrite, Urobilinogen, Protein, pH, Blood, Specific Gravity,Ketone, Bilirubin and Glucose |
| Mission® Urine Analysis StripU031-081 | 8 | 8U | Glucose, Bilirubin, Ketone, Blood, pH, Protein, Urobilinogen,Nitrite |
| 8N | Leukocytes, Nitrite, Protein, pH, Blood, Specific Gravity,Ketone and Glucose | ||
| 8S | Glucose, Specific Gravity, Blood, pH, Protein, Urobilinogen,Nitrite, Leukocytes | ||
| 8K | pH, Glucose, Bilirubin, Protein, Urobilinogen , Nitrite,Leukocytes, Ketone | ||
| Mission® Urine Analysis StripU031-071 | 7 | 7N | Glucose, Ketone, Blood, pH, Protein, Nitrite, Leukocytes |
| Mission® Urine Analysis StripU031-061 | 6 | 6NE | Glucose, Blood, pH, Protein, Nitrite, Leukocytes |
| 6UE | Bilirubin, Specific Gravity, Blood, Protein, Urobilinogen,Nitrite | ||
| Mission® Urine Analysis StripU031-051 | 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 StripU031-141 | 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 StripU031-031 | 3 | 3KE | Glucose, Ketone, Protein |
| 3GE | Glucose, Ketone, pH | ||
| 3NE | Blood, Nitrite, Leukocytes | ||
| 2GE | |||
| Mission® Urine Analysis StripU031-021 | 2 | 2KE | Glucose, Ketone |
| 2NE | Nitrite, Leukocytes | ||
| 2BE | Blood, Leukocytes | ||
| 2UE | Bilirubin, Urobilinogen | ||
| 2SE | |||
| Mission® Urine Analysis StripU031-011 | 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)25 Pin Parallel External Printer Port connector (included)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:
{5}------------------------------------------------
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(K070929) |
|---|---|---|
| Similarities | ||
| Intend of use | For Prescription, In VitroDiagnostic 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 OperationConditions | 0-40°C (32-104°F); ≤85% RelativeHumidity (non-condensing) | Same |
| Strips to be used | Mission® Urinalysis Reagent Strips | Same |
| Strip Operating Conditions | 15-30°C (59-86°F); ≤85% RelativeHumidity (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)25 Pin Parallel External Printer Portconnector (included)Barcode Reader (optional) | Same |
| Available Languages onScreen | English(default), Spanish, French(others as installed) | Same |
| Differences | ||
| Throughput | 500 tests/hour | Single Test Mode: 40tests/hour, Continuous TestMode: 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)(35.5 x 27.4 x 19.5)cm | 10.7"(L) x 10.4"(W) x 5.8"(H)(27.1 x 26.5 x 14.8) cm |
| Display Dimensions | 4.5"(W) x 3.5" (H)(11.5 × 9.0) cm | 4.2"(W) x 1.1"(H)(10.6 x 2.8) cm |
| Weight | 8.82 lbs (4.0 kg) | 5.73 lbs (2.6 kg ) |
{6}------------------------------------------------
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).
{8}------------------------------------------------
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
{9}------------------------------------------------
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)________________________________________________________________________________________________________________________________________________________________________
Page 1 of __
§ 864.6550 Occult blood test.
(a)
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.)(b)
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.