(261 days)
Not Found
No
The summary describes standard automated urine analysis technologies (test strip chemistry and flow cytometry) and does not mention AI, ML, or related concepts.
No.
The device is an in vitro diagnostic (IVD) device used for screening patient populations in clinical laboratories by analyzing urine samples for various parameters. It is not intended for treating or alleviating a disease or condition.
Yes
The device is described as "intended for in vitro diagnostic use in screening patient populations found in clinical laboratories," and it measures various parameters in urine to aid in diagnosis.
No
The device description clearly states that the AUTION HYBRID AU-4050 is a "fully automated integrated urine analyzer system" containing both a "test strip chemistry urine analyzer" and a "flow cytometry urine particle analyzer" in a "single integrated device." This indicates the presence of significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the system is "intended for in vitro diagnostic use in screening patient populations found in clinical laboratories." It also describes the measurement of various parameters in urine samples, which is a common application of IVD devices.
- Device Description: The description details how the device analyzes urine samples using both chemistry and flow cytometry, both of which are techniques used in in vitro diagnostics.
- Control Solution: The mention of "AUTION Control Solution is intended for in vitro diagnostic use only for performing quality control procedures" further confirms the IVD nature of the system.
The entire context of the document points to the device being used to perform tests on biological samples (urine) outside of the body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System: The AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (CHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet™ S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathologic Casts, Crystals, Sperm, Small Round Cells, Yeast Like Cells, and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Uriflet™ S 9HA Urine Test Strips: Uriflet™ S 9HA is a urinalysis test strip with reagent pads for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, and Leukocytes. Uriflet S 9HA is for use with the AUTION HYBRID AU-4050 only.
AUTION™ Control Solution: The AUTION Control Solution is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry module.
Product codes (comma separated list FDA assigned to the subject device)
JIO, KQO, LKM, JJW, JIL, CDM, JJB, JIN, JJR JMT, LIX, CEN, JRE
Device Description
The AUTION HYBRID AU-4050 is a fully automated urine analysis system. The AU-4050 contains a test strip chemistry urine analyzer also called the chemistry module (CHM) and a flow cytometry urine particle analyzer also called the flow cytometry module (FCM) together in a single integrated device. The CHM module analyzes the following parameters in urine: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The FCM module measures the following parameters in urine utilizing flow cytometry technology: Red Blood Cells. White Blood Cells. Epithelial Cells, Casts, and Bacteria. The FCM module flags for the presence of the following: Pathologic Casts, Crystals, Sperm, Small Round Cells. Yeast Like Cells and Mucus.
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
in screening patient populations found in clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical and bench testing was used to verify the performance characteristics of this device. This testing showed acceptable device performance that is substantially equivalent to the performance of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
§ 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.
0
arkray
FEB 0 1 2013
| 510(k) Summary | |
|---|---|
| Date Prepared: | January 18th, 2013 |
| Submitter: | ARKRAY Factory USA, Inc. |
| 5182 West 76th Street | |
| Minneapolis, MN 55439 | |
| Establishment Registration Number: 1832816 | |
| Contact Person: | Adam Ettl |
| Associate Regulatory Affairs Project Manager | |
| Phone: (952) 646-3142 | |
| Fax: (952) 646-3110 | |
| Email: ettla@arkrayusa.com | |
| Device Name and Regulatory Information | |
| Trade Name: | 1. ARKRAY AUTIONTM HYBRID AU-4050 Fully Automated |
| Integrated Urine Analyzer System |
-
- AUTION™ Control Solution
-
- Uriflet™ S 9HA Urinalysis Test Strips
- Common Name: 1. Automated Urinalysis System (Class I, Class II), Automated Urine Particle Analyzer (Class II)
- 2. Urinalysis Controls (Assayed and Unassayed) (Class 1, reserved)
-
- Urinalysis Test Strip
. ·
Table 1: Regulatory Information
| Regulation:
21 CFR
Section | Product
Code | Classification | Description |
|----------------------------------|-----------------|----------------------|-------------------------------------------------------------|
| 862.2900 | KQO | Class I | Automated Urinalysis System |
| 864.5200 | LKM | Class II | Counter, Urine Particle |
| 862.1660 | JJW | Class I,
reserved | Urinalysis Controls (Assayed and
Unassayed) |
| 862.1340 | JIL | Class II | Glucose (Urinary, Non-Quantitative) |
| 864.6550 | JIO | Class II | Blood, Occult, Colormetric, In Urine |
| 862.1785 | CDM | Class I | Urobilinogen (Urinary Non-Quant.) |
| 862.1550 | CEN | Class I | Ph (Urinary, Non-Quant.) |
| 862.1435 | JIN | Class I | Ketones (Urinary, Non-Quant.) |
| 862.1645 | JIR | Class I | Protein or Albumin (Urinary, Non-Quant.) |
| 862.1115 | JJB | Class I | Urinary Bilirubin & Its Conjugates (Urinary,
Non-Quant.) |
| 862.1510 | JMT | Class I | Nitrite (Urinary, Non-Quant.) |
| 864.7675 | LIX | Class I | Test, Urine Leukocyte |
1
| | 862.2900 | JRE | Class . | Refractometer for Clinical Use
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| -- | ---------- | ----- | --------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Predicate Devices
AUTION MAX AX-4030 Urinalysis System (K093098)
SYSMEX UF1000i Automated Urine Particle Analyzer with Urinalysis WAM software (K080887)
Sysmex UF-II Control (K070910)
Device Description
The AUTION HYBRID AU-4050 is a fully automated urine analysis system. The AU-4050 contains a test strip chemistry urine analyzer also called the chemistry module (CHM) and a flow cytometry urine particle analyzer also called the flow cytometry module (FCM) together in a single integrated device. The CHM module analyzes the following parameters in urine: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The FCM module measures the following parameters in urine utilizing flow cytometry technology: Red Blood Cells. White Blood Cells. Epithelial Cells, Casts, and Bacteria. The FCM module flags for the presence of the following: Pathologic Casts, Crystals, Sperm, Small Round Cells. Yeast Like Cells and Mucus.
Indications for Use
AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System
The AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (CHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet™ S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathologic Casts, Crystals. Sperm. Small Round Cells. Yeast Like Cells. and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
AUTION™ Control Solution
The AUTION Control Solution is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry module.
2
Uriflet S 9HA Urinalysis Test Strips
Uriflet™ S 9HA is a urinalysis test strip with reagent pads for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, and Leukocytes. Uriflet S 9HA is for use with the AUTION HYBRID AU-4050 only.
Comparison to Predicate Devices
A comparison of the ARKRAY AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analyzer System to the predicate devices indicates the following similarities:
- Same intended use .
- . Same technological characteristics
- Same operating principle �
- . Same design features
The comparison matrices presented below clearly demonstrate that the proposed AU-4050 device is substantially equivalent to the AX-4030 and UF-1000i devices; and the AUTION Control Solution is substantially equivalent to the UF-II Control with regard to the following important aspects:
- . Intended Use
- . Fundamental Technology
- . Performance Specifications
TABLE 1 below is a comparison between the AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analzer System and the AUTION MAX AX-4030 Urinalysis System (K093098) used for urine chemistry analysis.
TABLE 2 below is a comparison between the AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analzer System and the Sysmex UF-1000i Urine Particle Analyzer with Urinalysis WAM software (K080887) used for urine sediment analysis.
TABLE 3 below is a comparison between the AUTION Control Solution and the Sysmex UF-II Control solutions used for quality control purposes on the FCM unit of the AUTION HYBRID AU-4050.
3
| Category | Substantial Equivalence Comparison Table
AX-4030 (Predicate device-K093098) | AU-4050 (proposed
device) |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Intended Use | Automated urine chemistry analyzer for
the in vitro measurement of urine
chemistry analytes. | Same |
| Sample Type | Human Urine | Same |
| Sample Volume | 2 mL | 5 mL |
| Measurement
Wavelength | 430,500,565,635,760 nm | Same |
| Measurement Method | Operating Principle:
Spectrophotometery Test Strip: Dual-
wavelength reflectance measurement
(Single wavelength for BLD) S.G .:
Reflection refractometry Color Tone:
Light-transmission measurement
Turbidity: Light-scattering measurement | Same |
| Measurement Items | GLU, PRO, BIL, URO, PH, BLD, KET,
NIT, LEU, S.G, turbidity and color-tone | Same |
| Test Strip Reaction Time | Approx. 60 seconds | Same as AX-4030 |
| Processing Speed | 225 samples/hr | 200 samples/hr (CHM
mode); 100 samples/hr
(CHM + FCM mode) |
| Display | Large color liquid crystal display
(320 x 240 dots) | IPU computer screen |
| Built-in Printer | Yes | Yes |
| External Output | RS-232C/Ethernet | Same |
| Supply Voltage | 100-240 VAC, 50/60 Hz | Same |
| Site Location | For indoor use only | Same |
| Dimensions (mm) | 530 (W) x 530 (D) x 530
(H) | 800 (W) x 720 (D) x
720
(H) |
| Physical Layout | -Analyzer
-Sampler | Same |
| Weight | Approx. 41 kg | Approx. 120 kg |
| | TABLE 2 | |
| Substantial Equivalence Comparison Table | | |
| Category | UF-1000i (Predicate device-K080887) | AU-4050 (proposed
device) |
| Intended Use | Automated urine particle analyzer for
the in vitro measurement of urine
sediments. | Same |
| Sample Type | Human Urine | Same |
| Sample Volume | 3 mL | 5 mL |
| Measurement Wavelength | N/A | Same |
| Measurement Method | The device utilizes
Sysmex flow cytometry using a red
semiconductor laser for analyzing
organized elements or urine. Particle
characterization and identification is
based on detection of forward scatter,
fluorescence, and adaptive cluster
analysis. The UF-1000i uses the
addition of a new bacteria channel and
side scatter light signal. | Same |
| Measurement Items | RBC, WBC, Epithelial Cells, Cast, and
Bacteria and flags the presence of the
following: Pathologic Cast, Crystal,
Sperm, Small Round Cell, Yeast like
cell and Mucus. | Same |
| Test Strip Reaction Time | N/A | Same as AX-4030 |
| Processing Speed | 100 samples/hr | 200 samples/hr (CHM
mode); 100 samples/hr
(CHM + FCM mode) |
| Display | IPU computer screen | IPU computer screen |
| Built-in Printer | No | Yes |
| External Output | RS-232C/Ethernet | Same |
| Supply Voltage | 100-240 VAC, 50/60 Hz | Same |
| Site Location | For indoor use only | Same |
| Dimensions (mm) | 580 (W) x 710 (D) x 615
(H) | 800 (W) x 720 (D) x
720
(H) |
| Physical Layout | -Analyzer
-Sampler | Same |
| Weight | Approx. 75.5 kg | Approx. 120 kg |
.
,
and the contraction of the comments of the comments of the comments of
,
4
:
:
:
5
| TABLE 3
| Substantial Equivalence Comparison Table | ||
|---|---|---|
| Category | Sysmex UF-II Control (Predicate | |
| device-K070910) | AUTION Control | |
| Solution (Proposed | ||
| device) | ||
| Intended Use | UF II Control contains control particles | |
| for use in quality control mode of the | ||
| Sysmex Fully Automated Urine Particle | ||
| Analyzer (UF-1000i and UF-500i) and | ||
| Fully Automated Integrated Urine | ||
| Analyzer (UX-2000) | The AUTION Control | |
| Solution is intended for | ||
| in vitro diagnostic use | ||
| only for perfroming | ||
| quality control | ||
| procedures with the | ||
| AUTION HYBRID | ||
| AU-4050 flow | ||
| cytometry module. | ||
| Form | Liquid, ready to use | Same |
| Levels | 2 | Same |
| Storage Stability | 2°C-10°C until expiration date | Same |
| Open Vial Stability | 30 days at 2°C-10°C | Same |
| Matrix | Liquid matrix solution | Same |
| Analytes | Red Blood Cells, White Blood Cells, | |
| Epithelial Cells, Casts, and Bacteria | Same |
Summary of Performance Data
Clinical and bench testing was used to verify the performance characteristics of this device. This testing showed acceptable device performance that is substantially equivalent to the performance of the predicate devices.
Conclusion
Based upon the indications for use, comparison with the previously cleared predicate devices, technology and verification testing, ARKRAY has determined that the AUTION HYBRID AU-4050 described in this submission has been shown to be substantially equivalent to the predicate devices.
6
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
February 1, 2013
ARKRAY, Inc. c/o Adam Ettl 5182 West 76th Street Edina, Minnesota 55439
Re: K121456
Trade/Device Name: AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet™ S 9HA Urine Test Strips; AUTION Control Solution Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: JIO, KQO, LKM, JJW, JIL, CDM, JJB, JIN, JJR JMT, LJX, CEN, JRE Dated: December 18, 2012 Received: December 19, 2012
Dear Mr. Ettl,
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
7
Page 2 – Adam Ettl
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket s 1561 Yiers Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benson for
Courtney H. Lias, Ph.D.
Director
Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number: K121456
Device Name: AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System
Uriflet™ S 9HA Urine Test Strips
AUTION™ Control Solution
Indications for Use:
AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System
The AUTION HYBRID™ AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (CHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet™ S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathologic Casts, Crystals, Sperm, Small Round Cells, Yeast Like Cells, and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Ruth A. Chesler
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health (OIR)
510(k) K121456
Page 1 of 2
9
Indications for Use
510(k) Number: K121456
Uriflet™ S 9HA Urine Test Strips
Uriflet™ S 9HA is a urinalysis test strip with reagent pads for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, and Leukocytes. Uriflet S 9HA is for use with the AUTION HYBRID AU-4050 only.
AUTION™ Control Solution
The AUTION Control Solution is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry module.
× Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR
· Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Ruth A. Chesler
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health (OIR)
510(k) K121456
Page 2 of 2