(118 days)
No
The description focuses on reflectance photometry and data management, with no mention of AI or ML terms or concepts.
No
This device is an in vitro diagnostic (IVD) device used to analyze urine and aid in the diagnosis and monitoring of diseases, not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that "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." This indicates its role in aiding diagnosis.
No
The device description clearly states it is a "reflectance photometer" and analyzes the intensity and color of light, indicating it is a hardware device with optical components, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The instrument is intended for professional, in vitro diagnostic use only."
- Nature of the Test: The device analyzes urine samples to detect various analytes, which is a classic example of an in vitro diagnostic test. The analysis is performed on a sample taken from the body (urine) outside of the body (in vitro).
- Purpose of the Test: The intended use describes the purpose as aiding in the diagnosis and monitoring of various diseases and disorders, which is a core function of IVD devices.
N/A
Intended Use / Indications for Use
The ACON™ U120 Urine Analyzer is intended for use in conjunction with the ACON 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 ACON Urinalysis Reagent Strips are available in different combinations of the aforementioned analytes. The instrument is intended for professional, 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.
Product codes
KQO, JIL, JIO, LJX, CEN, JMT, JIR, JIN, CDM, JJB, JMA
Device Description
The U120 Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip.
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, in vitro diagnostic use only.
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)
Studies were conducted in-house and in clinical setting to demonstrate the performance of the ACON U120 Urine Analyzer and that the intended user can easily operate the system and obtain urinalysis results as the predicate device.
Laboratory Testing: The performance characteristics of the ACON U120 Urine Analyzer were verified by many tests including temperature flex study, humidity flex study, voltage flex study, repeatability study, readability study, electric security testing, device comparison study, configuration tests and operation tests.
Clinical Tests Performed: Clinical studies were conducted using the ACON U120 Urine Analyzer. Clinical study data are presented and clinical accuracy between the ACON U120 Urine Analyzer and Bayer Clinitek Status Urine Chemistry Analyzer per ACON clinical study protocol for U120 Urine Analyzer is compared. Study results indicate that the inexperienced intended users were able to obtain comparable testing results when using the ACON U120 Urine Analyzer and a legally marketed Bayer Clinitek Status Urine Chemistry Analyzer (K031947).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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JUL 30 2007
5. 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
Submitter's Identification:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121
Tel.: 858-875-8028 Fax: 858-875-8099
Date Prepared: June 27, 2007
Contact Person:
Jinn-nan Lin, Ph.D. V.P., Regulatory Affairs
Proprietary Name of the Device:
ACON™ U120 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 § 862.1115 Urinary Bilirubin and its Conjugates (Non-Quantitative) Test System |
| 21 CFR § 862.1435 Ketones (Non-Quantitative) Test System |
| 21 CFR § 864.6550 Occult Blood Test |
| 21 CFR § 862.1550 Urinary pH (Non-Quantitative) Test System |
| 21 CFR § 862.1645 Urinary Protein or Albumin (Non-Quantitative) Test System |
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- 21 CFR § 862.1785 Urinary Urobilinogen (Non-Quantitative) Test System
- 21 CFR & 862.1510 Nitrite (Non-Quantitative) Test System
- 21 CFR § 864.7675 Leukocyte Peroxidase Test
- Ascorbic Acid Test System 21 CFR § 862.1095
- 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
- Test, Urine Leukocyte LJX
- 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
- Urinary Urobilinogen (non-quant.) test system CDM
- Urinary Bilirubin & its conjugates (urinary, non-quant.) test system JJB
- Acid, Ascorbic, 2, 4-Dinitrophenylhydrazine (Spectrophotometric) JMA
Medical Specialty:
Clinical Chemistry
Predicate Device:
Bayer Clinitek Status Urine Chemistry Analyzer Bayer Healthcare, LLC, marketed by Bayer Healthcare, LLC, located at Medfield, MA 02052, USA. 510(k) Number: K031947
Description:
The U120 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, operators must visually compare the reagent areas of the strip to a color chart using the naked eye. Obviously, visual determination for urinalysis is a time
2
consuming task and is prone to inaccuracy due to human misinterpretation and variable light sources. To minimize the variability associated with visual testing, the ACON U120 Urine Analyzer is specifically designed for improved accuracy and efficiency of urinalysis featuring data management and report generation capabilities.
Intended Use:
The ACON™ U120 Urine Analyzer is intended for use in conjunction with the ACON 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 ACON Urinalysis Reagent Strips are available in different combinations of the aforementioned analytes. The instrument is intended for professional, 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.
| Feature | Specifications |
|---|---|
| Methodology | Reflectance Photometer |
| Detection | Photosensitive diode |
| Throughput | Single Test Mode: 40 tests/hour |
| Continuous Test Mode: 120 tests/hour | |
| Memory | Last 500 results |
| Strip Incubation Time | 1 minute |
| PC Port | Standard RS232C Port (cable not included) |
| Printing Capabilities | Internal heat-sensitive printer (included) |
| External printer (not included) | |
| 25 Pin Parallel External Printer Port (included) | |
| Available Languages on Screen | English and Spanish |
| Ambient Operating Conditions | 0-40°C (32-104°F); ≤85% Relative Humidity (non- |
| condensing) | |
| Optimum Operating Conditions | 15-30°C (59-86°F); ≤75% Relative Humidity (non- |
| condensing) | |
| Power Source | 220 Volts AC (±10%), 50 Hz (±1) |
| 110 Volts AC (±10%), 60 Hz (±1) 110-230V AC, 50/60Hz | |
| Line Leakage Current |