(65 days)
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No
The document describes a standard automated urinalysis system using established methods like reflectance spectroscopy and refractive index, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an automated urine analyzer that measures various analytes in urine for diagnostic purposes (in vitro measurement), not for direct treatment or prevention of disease.
Yes
The device is described as an "automated urine analyzer intended for the in vitro measurement of the following analytes," which are various chemical and physical properties of urine. These measurements are used to assess health conditions, which is a diagnostic purpose.
No
The device description explicitly states that the AUTION MAX Urinalysis System consists of an Analyzer, Sampler, and accessories, including mechanical systems and measurement units, indicating it is a hardware device with integrated software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the AUTION MAX is "intended for the in vitro measurement of the following analytes..." and "intended for use only with the AUTION Sticks 9EB multi-parameter test strips." This clearly indicates that the device is used to test samples (urine) outside of the body (in vitro) to provide diagnostic information.
- Device Description: The description details how the device analyzes urine specimens using methods like reflectance spectroscopy and refractive index, which are standard techniques for in vitro diagnostic testing of biological fluids.
- Performance Studies: The mention of performance studies evaluating characteristics like correlation, precision, carryover, and linearity are typical for IVD devices to demonstrate their analytical performance.
- Predicate Devices: The listing of predicate devices (K946183 and K983510) which are also automated urine analyzers, further supports that the AUTION MAX falls within the category of IVD devices.
The core function of the device is to analyze a biological sample (urine) in a laboratory setting to provide information about the patient's health, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AUTION MAX AX-4280 Urinalysis System (AUTION MAX) is an automated urine analyzer intended for the in vitro measurement of the following analytes: glucose (GLU), protein (PRO), bilirubin (BIL), urobilinogen (URO), pH, blood (BLD), ketones (KET), nitrite (NIT), leukocytes (LEU), specific gravity (SG), turbidity, and color. The AUTION MAX is intended for use only with the AUTION Sticks 9EB multi-parameter test strips.
Product codes (comma separated list FDA assigned to the subject device)
KQO, CDM, CEN, JIL, JIN, JIO, JIR, JJB, JMT, JRE, LJX
Device Description
The AUTION MAX Urinalysis System consists of an Analyzer, Sampler, and accessories. ARKRAY also offers an external printer and hand-held Bar Code Reader for use with the AUTION MAX. The sample-handling capacity of the AUTION MAX can be expanded through the use of the Extensional Sampler. The AUTION MAX Analyzer is designed for use with the AUTION Sticks 9EB multi-parameter test strips.
The proposed AUTION MAX Analyzer contains:
- Mechanical systems for handling the test strips, urine specimens, wash solution, and system waste
- Measurement units for reading the test strips and analyzing the physical properties of the urine
- Software control system for automation of Analyzer and Sampler operation, processing commands and information input by the user, displaying system and specimen information, and monitoring system functions
- RS-232C interface for exporting measurement results and urine speciment identification information
The AUTION MAX uses a rack system for urine specimen handling. The AUTION MAX Sampler automatically feeds sample racks to the Analyzer. The Sampler contains a Bar Code Reader for urine specimen identification.
The proposed AUTION MAX Analyzer uses reflectance spectroscopy for the measurement of the urine analytes GLU, PRO, BIL, URO, pH, BLD, KET, NIT, LEU, and urine color. Urine SG is determined using the refractive index method, and turbidity is evaluated by measuring the transmission and scattering of light passing through the urine specimen.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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)
Several studies were conducted to evaluate the performance characteristics of the AUTION MAX Urinalysis System. A correlation study demonstrated excellent agreement when results from the AUTION MAX were compared to those from a commercially available automated urine analyzer. Additional studies for precision, carryover, and linearity demonstrated acceptable performance of the AUTION MAX System for its intended use.
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.
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.
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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).
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§ 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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JAN 1 8 2002
510(k) Summary
for
AUTION MAX™ AX-4280 Urinalysis System
1. SPONSOR
International Remote Imaging Systems, Inc. 9162 Eton Avenue Chatsworth, CA 91311
| Contact Person: | William M. Dougherty |
|---|---|
| Manager | |
| Quality Assurance and Evaluations | |
| Telephone: | 818-709-1244, ext. 140 |
November 12, 2001 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | AUTION MAX AX-4280 Urinalysis System |
|---|---|
| Common/Usual Name: | Urinalysis System |
| Classification Name: | Automated Urinalysis System |
PREDICATE DEVICES 3.
- Clinitek Atlas Automated Urine Chemistry Analyzer, Bayer Corporation ● (K946183)
- Chemstrip® Super UA™ Automated Urine Analyzer, Boehringer Mannheim . Corporation (K983510)
DEVICE DESCRIPTION 4.
The AUTION MAX Urinalysis System consists of an Analyzer, Sampler, and accessories. ARKRAY also offers an external printer and hand-held Bar Code Reader for use with the AUTION MAX. The sample-handling capacity of the AUTION MAX can be expanded through the use of the Extensional Sampler. The
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AUTION MAX Analyzer is designed for use with the AUTION Sticks 9EB multiparameter test strips.
INTENDED USE ર.
The AUTION MAX AX-4280 Urinalysis System (AUTION MAX) is an automated urine analyzer intended for the in vitro measurement of the following analytes: glucose (GLU), protein (PRO), bilirubin (BIL), urobilinogen (URO), pH, blood (BLD), ketones (KET), nitrite (NIT), leukocytes (LEU), specific gravity (SG), turbidity, and color. The AUTION MAX is intended for use only with the AUTION Sticks 9EB multi-parameter test strips.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The AUTION MAX is substantially equivalent to the Clinitek Atlas Automated Urine Chemistry Analyzer with Rack Sample Handler (Clinitek Atlas), manufactured by Bayer Corporation (K946183). The Clinitek Atlas is intended for use with the Clinitek® Atlas® Reagent Pack reagent strips. Both the proposed AUTION MAX and the Clinitek Atlas measure urine GLU, PRO, BIL, URO, pH, BLD, KET, NIT, LEU, SG, color, and clarity.
The AUTION MAX is also substantially equivalent to the Chemstrip® Super UATM Automated Urine Analyzer (Chemstrip Super UA), manufactured by Boehringer Mannheim Corporation (K983510). The Chemstrip Super UA is intended for use with the Chemstrip® 10 S-UA urine test strips. The Chemstrip Super UA measures urine GLU, PRO, BIL, URO, pH, BLD, KET, NIT, LEU, and SG.
The proposed AUTION MAX Analyzer contains:
- Mechanical systems for handling the test strips, urine specimens, wash . solution, and system waste
- Measurement units for reading the test strips and analyzing the physical . properties of the urine
- Software control system for automation of Analyzer and Sampler operation, . processing commands and information input by the user, displaying system and specimen information, and monitoring system functions
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- RS-232C interface for exporting measurement results and urine speciment . identification information
The AUTION MAX uses a rack system for urine specimen handling. The AUTION MAX Sampler automatically feeds sample racks to the Analyzer. The Sampler contains a Bar Code Reader for urine specimen identification.
The overall design of the predicate Clinitek Atlas and the Chemstrip Super UA is similar to that of the proposed AUTION MAX, with the exception that the urine specimens are transported to the Chemstrip Super UA analyzer using a turntable rather than a rack system.
The proposed AUTION MAX Analyzer uses reflectance spectroscopy for the measurement of the urine analytes GLU, PRO, BIL, URO, pH, BLD, KET, NIT, LEU, and urine color. Urine SG is determined using the refractive index method, and turbidity is evaluated by measuring the transmission and scattering of light passing through the urine specimen. These analytical methods are identical to the methods used by the predicate Clinitek Atlas. The predicate ChemStrip Super UA uses reflectance spectroscopy for the measurement of all urine analyte species, including SG.
The AUTION Sticks 9EB multi-parameter test strips contain reactive pads impregnated with reagents formulated to react with a specific urine analyte. Each strip also contains a correction pad with no reagents for urine color determination. Like the proposed AUTION Sticks, the Clinitek Atlas reagent strips and the Chemstrip 10 S-UA test strips consist of reagent pads on a non-reactive plastic backing.
The mechanisms of action for the chemical reactions used for the determination of urinary analytes, including glucose and occult blood, are similar for the proposed and The chemical constituents of the individual reagent predicate test strips. formulations are similar for the proposed and predicate reagent pads, with minor differences in the choice of enzyme substrate and chromogens used for production of the colored endproduct.
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7. PERFORMANCE TESTING
Several studies were conducted to evaluate the performance characteristics of the AUTION MAX Urinalysis System. A correlation study demonstrated excellent agreement when results from the AUTION MAX were compared to those from a commercially available automated urine analyzer. Additional studies for precision, carryover, and linearity demonstrated acceptable performance of the AUTION MAX System for its intended use.
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Image /page/4/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and a curved line representing its body. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the border of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
International Remote Imaging Systems, Inc. c/o Cynthia J. M. Nolte, Ph.D., RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
JAN 1 8 2002
Re: K013783
Trade/Device Name: AUTION MAXTM AX-4280 URINALYSIS SYSTEM Regulation Number: 21 CFR 862.2900, 862.1785, 862.1340, 862.1435, 864.6550, 862.1645, 862.1115, 862.1510, 862.2800, 864.7675 Regulation Name: Automated Urinalysis System, Urinary urobilinogen (nonquantitative) test system, Urinary pH (nonquantitative) test system, Urinary glucose (nonquantitative) test system, Ketones (nonquantitative) test system, Occult blood test, Urinary protein or albumin (nonquantitative) test system, Urinary bilirubin and its conjugates (nonquantitative) test system, Nitrite (nonquantitative) test system, Refractometer for clinical use, Leukocyte peroxidase test Regulatory Class: Class I, II Product Code: KQO, CDM, CEN, JIL, JIN, JIO, JIR, JJB, JMT, JRE, LJX Dated: November 12, 2001 Received: November 14, 2001
Dear Dr. Nolte:
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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his lotton will and it 300 ding of substantial equivalence of your device to a legally marketed nouticate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 If you desire arrivation and in the diagnostic devices), please contact the Office of Compliance at additionally 607.10 101 ====================================================================================================================================================== (201) 594-1560. Traditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miormation on your respond and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrf/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): గ013783
Device Name: _AUTION MAX™ AX-4280 Urinalysis System
Indications for Use:
The AUTION MAX AX-4280 Urinalysis System (AUTION MAX) is an The "TO FOTO - 12 22" analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, in tri allarytes. Eracobo, provity, turbidity, and color. The AUTION MAX is intended for use only with AUTION Sticks 9EB multi-parameter test strips.
Sean Cooper
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
November 12, 2001