(261 days)
No
The description focuses on reflectance photometry and standard analytical performance metrics, with no mention of AI/ML terms or methodologies.
No
The device is an in vitro diagnostic (IVD) device used for semi-quantitative detection of analytes in urine to aid in diagnosis and monitoring, which is not a therapeutic function.
Yes
The "Intended Use / Indications for Use" section states that the device "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," explicitly indicating its diagnostic purpose.
No
The device description explicitly states it is a "semi-automated reflectance photometer" and analyzes light reflected from reagent strips, indicating it is a hardware device with integrated software, not a software-only device.
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 prescription, for in vitro diagnostic use only."
- Function: The device analyzes urine samples using reagent strips to detect various analytes. This process is performed in vitro (outside of the living body) on a biological specimen (urine) to provide information for diagnosis and monitoring of diseases.
- Regulatory Context: The document mentions performance studies and comparison to a predicate device (K070929), which are typical requirements for IVD devices seeking regulatory clearance.
Therefore, based on the provided information, the Mission® U500 Urine Analyzer is clearly an In Vitro Diagnostic device.
N/A
Intended Use / 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
KQO, JIL, JIO, LJX, CEN, JMT, JIR, JIN, CDM, JJB, JMA, JRE
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
ACON U120 Urine Analyzer, K070929
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.
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
§ 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.
0
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.
| # of
Parameters | Catalog
No. | Type of
Strip | Analytes |
|--------------------|----------------|------------------|-----------------------------------------------------------------------------------------------------------------------------|
| 8 | U031-081 | 8N | Leukocytes, Nitrite, Protein, pH, Blood, Specific Gravity,
Ketone and Glucose |
| 9 | U031-091 | 9U | Nitrite, Urobilinogen, Protein, pH, Blood, Specific
Gravity, 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 Ascorbic
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
Parameters | Type of Strip | Analytes |
|-------------------------------------------|----------------------|---------------|--------------------------------------------------------------------------------------------------------------------------|
| Mission® Urine Analysis Strip
U031-111 | 11 | 11A | Leukocytes, Nitrite, Urobilinogen, Protein, pH, Blood, Specific
Gravity, Ketone, Bilirubin, Glucose and Ascorbic Acid |
| Mission® Urine Analysis Strip
U031-101 | 10 | 10U | Leukocytes, Nitrite, Urobilinogen, Protein, pH, Blood, Specific
Gravity, Ketone, Bilirubin and Glucose |
| | | 10A | Ascorbic Acid, Glucose, Bilirubin, Ketone, Specific Gravity,
Blood, pH, Protein, Urobilinogen, Nitrite |
| Mission® Urine Analysis Strip
U031-091 | 9 | 9U | Nitrite, Urobilinogen, Protein, pH, Blood, Specific Gravity,
Ketone, Bilirubin and Glucose |
| Mission® Urine Analysis Strip
U031-081 | 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 Strip
U031-071 | 7 | 7N | Glucose, Ketone, Blood, pH, Protein, Nitrite, Leukocytes |
| Mission® Urine Analysis Strip
U031-061 | 6 | 6NE | Glucose, Blood, pH, Protein, Nitrite, Leukocytes |
| | | 6UE | Bilirubin, Specific Gravity, Blood, Protein, Urobilinogen,
Nitrite |
| Mission® Urine Analysis Strip
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
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
U031-031 | 3 | 3KE | Glucose, Ketone, Protein |
| | | 3GE | Glucose, Ketone, pH |
| | | 3NE | Blood, Nitrite, Leukocytes |
| | | | 2GE |
| Mission® Urine Analysis Strip
U031-021 | 2 | 2KE | Glucose, Ketone |
| | | 2NE | Nitrite, Leukocytes |
| | | 2BE | Blood, Leukocytes |
| | | 2UE | Bilirubin, Urobilinogen |
| | | | 2SE |
| Mission® Urine Analysis Strip
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 |