(269 days)
No
The description details a semi-automated system that measures color changes on test strips using reflectance, which is a standard optical measurement technique, not AI/ML. There is no mention of AI, ML, or related concepts like image processing for interpretation.
No.
This device is an in vitro diagnostic (IVD) system used for screening patient populations in clinical laboratories to measure various components in urine, which helps in diagnosis, but it does not treat or cure any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended for in vitro diagnostic use in screening patient populations found in clinical laboratories." Additionally, the "Device Description" mentions that the results "can be used along with other diagnostic information to rule out certain disease states".
No
The device description explicitly states that the system consists of a hardware component (AUTION ELEVEN model AE-4022 Urine Analyzer) and a reagent component (AUTION Sticks 10EA Test Strips), in addition to any software that may be present.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use/Indications for Use: The document clearly states: "The system is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories."
- Explicit Statement in Device Description: The document reiterates: "The system is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories."
- Functionality: The device analyzes urine specimens using chemical reactions on test strips to provide qualitative and semi-quantitative measurements of various analytes. This process is performed in vitro (outside the body) on a biological sample for diagnostic purposes.
- Intended User/Care Setting: The intended use in "clinical laboratories" further supports its role in diagnostic testing.
N/A
Intended Use / Indications for Use
The AUTION ELEVEN Semi-Automated Urinalysis System provides a qualitative and semi-quantitative measurements for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity and color tone in urine specimens. The system is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
The AUTION ELEVEN Semi-Automated Urinalysis System consists of the following:
- AUTION ELEVEN model AE-4022 Urine Analyzer (device component)
- AUTION Sticks 10EA Test Strips (reagent component)
Product codes (comma separated list FDA assigned to the subject device)
JIL, JIO, KQO, CDM, CEN, JIN, JIR, JJB, JMT, LJX, JRE
Device Description
The AUTION ELEVEN Semi-Automated Urinalysis System provides a qualitative and semi-quantitative measurement for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity and color tone. The system is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The AUTION ELEVEN Semi-Automated Urinalysis System consists of AUTION ELEVEN model AE-4022 urine analyzer and AUTION Sticks 10EA test strips.
The AUTION sticks 10EA consist of a plastic strip containing 10 pads impregnated with chemicals specific for the determination of a particular analyte. The chemical reaction with the urine results in a color change which is measured by the AUTION ELEVEN AE-4022 device, resulting in a display and print out indicating analyte concentration. The AUTION ELEVEN technology provides fast results that can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
The semi-automated nature of the device requires the user to dip an AUTION Stick 10EA test strip into a patient urine specimen and place it on the instrument. The instrument processes the test strip, allowing 60 seconds for the chemical reactions to occur on the test strip reagent pads. After 60 seconds, the device measures the amount of reflectance generated from each reagent pad and converts the reflectance measurements to qualitative and semi-quantitative results for physician use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Colorimetric Reflectometry
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Precision Study:
- Sample Size: Each analyte was tested at 3 clinical sites.
- Data Source: Not explicitly stated, implied to be clinical sites.
- Annotation Protocol: Three (3) levels of quality controls were used to attain results at negative, midlevel positive and high-positive analyte ranges. Two (2) levels of commercial controls were used to obtain the 3 levels, using dilutions and spiking materials as needed to obtain the highest and mid-level controls for testing of all the analyte ranks.
Comparison Study:
- Sample Size: 2199 samples for Glucose, 563 for Protein, 2323 for Bilirubin, 2308 for Urobilinogen, 2307 for pH, 548 for Specific Gravity, 548 for Blood, 2221 for Ketones, 2209 for Nitrite, 548 for Leukocyte. Total of 8395 tests of individual analytes.
- Data Source: Urine patient samples collected from clinical laboratories or obtained from nearby hospitals.
- Annotation Protocol: Urine samples were collected and refrigerated within 2 hours of collection, for up to 24 hours of refrigeration prior to clinical study testing. For inclusion into the study, the samples collected had to be positive for at least one of the chemistry analytes present on the AUTION Stick 10EA urinalysis strip. Data from each site was combined for the analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision Study:
- Study Type: Precision Study (Repeatability and Reproducibility).
- Sample Size: Each analyte was tested at 3 clinical sites using 3 operators on 3 devices for a minimum of 20 days. Three (3) levels of quality controls were used per analyte.
- Key Results:
- Repeatability Exact Match %: Glucose 98%, Protein 100%, Bilirubin 99%, Urobilinogen 99%, pH 98%, Specific gravity 96%, Blood 99%, Ketones 100%, Nitrite 100%, Leukocytes 100%.
- Repeatability +/- 1 Color Block %: All analytes 100%.
- Reproducibility Exact Match %: Glucose 99%, Protein 100%, Bilirubin 99%, Urobilinogen 100%, pH 99%, Specific gravity 97%, Blood 100%, Ketones 100%, Nitrite 100%, Leukocytes 100%.
- Reproducibility +/- 1 Color Block %: All analytes 100%.
- Overall conclusion: The results are acceptable and support a determination of substantial equivalence.
Comparison Study:
- Study Type: Method Comparison Study.
- Sample Size: 2199 samples for Glucose, 563 for Protein, 2323 for Bilirubin, 2308 for Urobilinogen, 2307 for pH, 548 for Specific Gravity, 548 for Blood, 2221 for Ketones, 2209 for Nitrite, 548 for Leukocyte. Total of 8395 tests of individual analytes.
- Key Results:
- Exact Agreement with Predicate: Glucose 98%, Protein 86%, Bilirubin 100%, Urobilinogen 98%, pH 89%, Specific Gravity 81%, Blood 92%, Ketones 96%, Nitrite 99%, Leukocyte 92%.
- Agreement within +/- 1 color block: Glucose 100%, Protein 100%, Bilirubin 100%, Urobilinogen 100%, pH 100%, Specific Gravity 99%, Blood 100%, Ketones 100%, Nitrite 100%, Leukocyte 100%.
- Overall conclusion: The results are acceptable and support a determination of substantial equivalence.
Interfering Substances Study:
- Study Type: Assessment of Interfering Substances.
- Sample Size: Not specified.
- Key Results: Observed false negatives or positives for certain analytes at specific interferent concentrations (e.g., Glucose: False negative with >50 mg/dL Ascorbic acid; Leukocytes: False negative with >200 mg/dL Glucose).
Detection Limits/Sensitivity Results:
- Study Type: Evaluation of Detection Limits/Sensitivity.
- Sample Size: Not specified, but actual concentrations were tested for each qualitative and semi-quantitative rank, with results indicating the percent of samples that fell into the specified rank.
- Key Results: Detailed table showing the actual concentration achieved for each qualitative and semi-quantitative rank for all analytes, along with the percentage of samples that fell into that rank. For example, for Glucose 4+, Actual Concentration 750 mg/dL, Percent in Rank 87%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Precision: Exact match (Repeatability and Reproducibility) and +/- 1 Color Block match (Repeatability and Reproducibility).
- Accuracy (Agreement with Predicate): Exact Agreement with Predicate and Agreement within +/- 1 color block.
- Detection Limits/Sensitivity: Actual Concentration and Percent in Rank.
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.
AUTION MAX AX-4030 Urinalysis System (K093098)
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.
AUTION JET (K030600)
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
§ 862.1340 Urinary glucose (nonquantitative) test system.
(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7, 2016
ARKRAY, INC. NAVEEN THURAMALLA VICE PRESIDENT, REGULATORY AFFAIRS 5182 76TH STREET EDINA MN 55439
Re: K160062
Trade/Device Name: AUTION ELEVEN Semi-Automated Urinalysis System Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: II Product Code: JIL, JIO, KQO, CDM, CEN, JIN, JJR, JJB, JMT, LJX, JRE Dated: August 29, 2016 Received: August 30, 2016
Dear Naveen Thuramalla:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 Parts 801 and 809); 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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney H. Lias -S
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
2
Indications for Use
510(k) Number (if known) K160062
Device Name
AUTION ELEVEN Semi-Automated Urinalysis System
Indications for Use (Describe)
The AUTION ELEVEN Semi-Automated Urinalysis System provides a qualitative and semi-quantitative measurements for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity and color tone in urine specimens. The system is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
The AUTION ELEVEN Semi-Automated Urinalysis System consists of the following:
- · AUTION ELEVEN model AE-4022 Urine Analyzer (device component)
- · AUTION Sticks 10EA Test Strips (reagent component)
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Research Use Only (21 CFR 201.3 Subject to Review)
Over-The-Counter Use Only (21 CFR 201.3 Subject to Review)
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) Summary of the AUTION ELEVEN Semi-Automated Urinalysis System is submitted in compliance of 21 CFR 807.92 for the purposes of safety and effectiveness.
| 510(k) Number: | K160062 |
|---|---|
| Date Prepared: | October 06, 2016 |
| Establishment: | ARKRAY Inc. |
| Yousuien-Nai | |
| 59 Gansuin-Cho, Kamigyo-Ku | |
| Kyoto 602-0008, Japan | |
| Establishment Registration Number: 9611444 | |
| Submitter: | ARKRAY, Inc. |
| 57 Nishiaketa-Cho, Higashi-Kujo, Minami-Ku | |
| Kyoto 601-8045, Japan | |
| Telephone: 81-75-968-9003 | |
| Fax: 81-75-662-8977 |
Official US Agent: Tom Speikers
ARKRAY Factory USA, Inc.
VP, Regulatory Affairs and Quality Systems
Phone: (952) 646-3168
Fax: (952) 646-3110
Email: SpeikersT@arkrayusa.com |
| Contact Person: | Naveen Thuramalla
ARKRAY Factory USA, Inc.
Vice President, Regulatory Affairs
Phone: (cell): 202-738-8303
Email: ThuramallaN@arkrayusa.com |
4
Device Name
| Trade Name: | AUTION ELEVEN Semi-Automated Urinalysis System |
|---|---|
| Common Name: | Automated Urinalysis System |
| 510(k) Number: | K160062 |
| Regulation:
21 CFR
Section | Product
Code | Classification | Description |
|----------------------------------|-----------------|----------------|-------------------------------------------------------------|
| 862.1340 | JIL | Class II | Glucose (Urinary, Non-Quantitative) |
| 864.6550 | JIO | Class II | Blood, Occult, Colorimetric, In Urine |
| 862.2900 | KQO | Class I | Automated Urinalysis System |
| 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 | LJX | Class I | Test, Urine Leukocyte |
| 862.2800 | JRE | Class I | Specific Gravity |
Table 1: Regulatory Information
Predicate Devices
AUTION MAX AX-4030 Urinalysis System (K093098)
5
Intended Use
The AUTION ELEVEN Semi-Automated Urinalysis System provides a qualitative and semi-quantitative measurements for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity and color tone in urine specimens. The system is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
The AUTION ELEVEN Semi-Automated Urinalysis System consists of the following:
- AUTION ELEVEN model AE-4022 urine analyzer (device component) ●
- AUTION Sticks 10EA test strips (reagent component) ●
Device Description
The AUTION ELEVEN Semi-Automated Urinalysis System provides a qualitative and semi-quantitative measurement for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity and color tone. The system is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. The AUTION ELEVEN Semi-Automated Urinalysis System consists of AUTION ELEVEN model AE-4022 urine analyzer and AUTION Sticks 10EA test strips.
The AUTION sticks 10EA consist of a plastic strip containing 10 pads impregnated with chemicals specific for the determination of a particular analyte. The chemical reaction with the urine results in a color change which is measured by the AUTION ELEVEN AE-4022 device, resulting in a display and print out indicating analyte concentration. The AUTION ELEVEN technology provides fast results that can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
The semi-automated nature of the device requires the user to dip an AUTION Stick 10EA test strip into a patient urine specimen and place it on the instrument. The instrument processes the test strip, allowing 60 seconds for the chemical reactions to occur on the test strip reagent pads. After 60 seconds, the device measures the amount of reflectance generated from each reagent pad and converts the reflectance measurements to qualitative and semi-quantitative results for physician use.
6
Substantial Equivalence
| # | Element of
Comparison | AUTION MAX AX-4030
(Predicate) | Claimed
Substantial
Equivalent
Device, AUTION
ELEVEN
Semi-Automated
Urinalysis System | AUTION
ELEVEN
Comparison |
|----|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Proprietary
Name | AUTION MAX | AUTION
ELEVEN | N/A |
| 2 | 510(k) Number | K093098 (2009) | K160062 | N/A |
| 3 | Class | Class II (Blood and Glucose
analytes raise system to
Class II / 510(k) required) | Class II (Blood
and Glucose
analytes raise
system to Class II /
510(k) required) | SAME |
| 4 | Data Type | Qualitative, Semi-
Quantitative | Qualitative, Semi-
Quantitative | SAME |
| 5 | Location | Clinical Laboratory | Clinical
Laboratory | SAME |
| 6 | Medical
Device/IVD | Medical Device/IVD | Medical
Device/IVD | SAME |
| 7 | Specimen | Human Urine | Human Urine | SAME |
| 8 | Analytes | Glucose
Protein
Bilirubin
Urobilinogen
pH
Blood
Ketones
Nitrite
Leukocyte
Specific Gravity | Glucose
Protein
Bilirubin
Urobilinogen
pH
Blood
Ketones
Nitrite
Leukocyte
Specific Gravity | SAME |
| 9 | Color Tone
Detection | 23 color tones using 3
wavelengths (red, green and
blue); executed by a color
tone unit with a different
calculation | 23 color tones
using 4
wavelengths (red,
green, blue,
infrared); executed
by the optical unit | Testing
demonstrates
color tone
detection. |
| # | Element of
Comparison | AUTION MAX AX-4030
(Predicate) | Claimed
Substantial
Equivalent
Device, AUTION
ELEVEN
Semi-Automated
Urinalysis System | AUTION
ELEVEN
Comparison |
| 10 | Color Tone
correction | Calculation to mitigate urine
color interference | Calculation to
mitigate urine
color interference | Testing shows
color does not
inhibit results. |
| 11 | Abnormal
Color Marker
(!)
(ketone,
urobilinogen,
bilirubin) | Calculations based on
wavelengths 430nm, 500nm,
565nm, and 635nm | Calculations based
on wavelengths
430nm, 500nm,
565nm, and 635nm | Same formula
comparing the
analyte pad
reflectance
ratio of 2
colors divided
by the
reference pad
reflectance
ratio of the
same 2 colors. |
| 12 | Turbidity/
Clarity | Determines turbidity | Does not
determine
turbidity. Option
available for user
to enter level of
clarity per
laboratory
professional
education. | Device does
not determine
this optional
parameter. |
| # | Element of
Comparison | AUTION MAX AX-4030
(Predicate) | Claimed
Substantial
Equivalent
Device, AUTION
ELEVEN
Semi-Automated
Urinalysis System | AUTION
ELEVEN
Comparison |
| 13 | Reagent Test
Strips | AUTION Sticks 9EB:
(1) No specific gravity
reagent pad (uses
Refractometer);
(2) Uses blank pad for
correction due to urine
color; different calculation
(3) Has black marker for
model distinction by device | AUTION
Sticks10EA:
(1) Has specific
gravity reagent
pad;
(2) Uses blank pad
for correction due
to urine color;
(3) Has black
marker for model
distinction by
device | SAME as
AUTION
MAX for all
reagent pads
except
specific
gravity.
SAME
chemical
reactions, as
AUTION
MAX.
AUTION
ELEVEN was
compared to
AUTION
MAX for 9
analytes, as
the more
recent
predicate, and
was compared
to AUTION
JET
(K030600) for
specific
gravity only. |
| 14 | Quality Control
Solution | Commercial urine analyzer
Control Solution | Commercial urine
analyzer Control
Solution | SAME |
| # | Element of
Comparison | AUTION MAX AX-4030
(Predicate) | Claimed
Substantial
Equivalent
Device, AUTION
ELEVEN
Semi-Automated
Urinalysis System | AUTION
ELEVEN
Comparison |
| 15 | Check Strips –
for quality
control of
device optical
unit's light
intensity | AUTION Check Strips
(provided with device) | AUTION Check
Strips (provided
with device) | SAME |
| 16 | Method of
device
chemistry
determination | Colorimetric Reflectometry
of reagent chemical reaction
with analyte for all analytes
*except Refractometry for
specific gravity | Colorimetric
Reflectometry of
reagent chemical
reaction with
analyte for all
analytes | SAME as
AUTION
MAX for all
reagent pads
except
specific
gravity.
SAME as
AUTION JET
(K030600) for
specific
gravity. |
| 17 | Barcode
Reader
Possible/Not
Required | Yes | Yes | SAME |
| 18 | Urine mixed
for
homogeneity | By hand and aspirator | By hand | Clinical
Testing shows
that AUTION |
| 19 | Urine applied
to reagent pad | Automatic pipette-applied | Hand-dipped for 2
seconds | MAX and
AUTION |
| # | Element of
Comparison | AUTION MAX AX-4030
(Predicate) | Claimed
Substantial
Equivalent
Device, AUTION
ELEVEN
Semi-Automated
Urinalysis System | AUTION
ELEVEN
Comparison |
| 20 | Timing
between urine
application and
determination | Automatic | Controlled by
Human
count/sound
alarms +
automation | ELEVEN
devices
perform
similarly and
there is no
additional
effect on
safety and
effectiveness. |
| 21 | Timing of
reagent
reaction | Approximately 60 seconds | Approximately 60
seconds | SAME |
| 22 | Result
determination | Automatic | Automatic | SAME |
| 23 | Rank Table | Includes Qualitative and
Semi-Quantitative Ranks | Includes
Qualitative and
Semi-Quantitative
Ranks; Semi-
Quantitative ranks
match Qualitative
ranks in number | SAME; All
Semi-
Quantitative
ranks within
the respective
Qualitative
rank are
combined.
The ranks
align with
predicate
Qualitative
ranks and
their
respective
Semi-
Quantitative
concentration
limits
although only
1 Semi- |
| # | Element of
Comparison | AUTION MAX AX-4030
(Predicate) | Claimed
Substantial
Equivalent
Device, AUTION
ELEVEN
Semi-Automated
Urinalysis System | AUTION
ELEVEN
Comparison |
| | | | | Quantitative
concentration
reference is
provided
where therefor a
predicate
Semi-
Quantitative
rank. |
| 24 | Software-
Controlled | Yes | Yes | SAME |
| 25 | Printed Data
Report | Yes | Yes | SAME |
| 26 | Measurement
Wavelengths
for Analytes | Dual wavelength
measurement using 565,
635, 760 nm (Except blood,
which uses only 635 nm) | Dual wavelength
measurement
using 565, 635,
760 nm (Except
blood, which uses
only 635 nm) | SAME |
| 27 | Processing
Speed | 225 samples/hr | 514 samples/hr | Result
determination
time remains
the same, so
no difference
in technology
or chemistry
– just
throughput. |
| 28 | Memory
Capacity | 2500 tests | 520 tests | Testing for
electronic
safety and
compatibility. |
| 29 | Crystal (LC)
Display | Yes | Yes | |
| 30 | Built-in printer | Yes | Yes | |
| 31 | External output | RS-232C/Ethernet | RS-232C/Ethernet | |
| # | Element of
Comparison | AUTION MAX AX-4030
(Predicate) | Claimed
Substantial
Equivalent
Device, AUTION
ELEVEN
Semi-Automated
Urinalysis System | AUTION
ELEVEN
Comparison |
| 32 | Barcode
Specifications | NW-7, CODE39, code 128,
ITF;
On unit | NW-7, CODE39,
code 128, ITF;
hand held type | |
| 33 | Voltage Supply | 100-240 VAC, 50/60 Hz | 100-240 VAC,
50/60 Hz; use
adapter 12 VDC
3A | |
| 34 | Dimensions
(mm) | 530 (w) x 530(d) x 530 (h) | 210 (w) x 328 (d)
x 164 (h) | N/A |
| 35 | Linearity | Yes | Yes | SAME |
| 36 | Sensitivity | Yes | Yes | SAME |
| 37 | Interfering
Substances | Yes | Yes | SAME |
| 38 | Detection
Limit/
Specificity | Yes | Yes | SAME |
| 39 | Accuracy by
Comparison | Yes | Yes | SAME |
| 40 | Precision | Yes | Yes | SAME |
| 41 | Color Tone
Detection | Yes | Yes | SAME |
| 42 | Color Tone
Correction | Yes | Yes | SAME |
| 43 | Electrical
Safety | Yes | Yes | Slight
differences |
| 44 | Radiofrequency | Yes | Yes | per |
| 45 | Electrical
Compatibility | Yes | Yes | specifications.
Testing |
| 46 | Device
Software | Yes | Yes | ensures safety
and efficacy. |
| 47 | Stability-
Closed Bottle | Yes | Yes | SAME |
| 48 | Stability-Open
Bottle | Yes | Yes | SAME |
Table 2: Substantial Equivalence
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10
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12
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Standards Referenced
Clinical and Laboratory Standards Institute. (2014). EP05-A3 Vol 34 No.13 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline-Third Ed.
Clinical and Laboratory Standards Institute. (2003). EP06-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline.
Clinical and Laboratory Standards Institute. (2005). EP07-A2 Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition.
Clinical and Laboratory Standards Institute. (2010). EP09-A2-IR Vol. 30 No. 17 Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Second Edition.
Clinical and Laboratory Standards Institute. (2009). GP-16-A2 21 No.19 Urinalysis: Approved Guideline - Third Edition.
Clinical and Laboratory Standards Institute. (2012). EP17-A2 Vol 32 No.8 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline- Second Edition.
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Test Principle
The AUTION ELEVEN Semi-Automated Urinalysis System device model AE-4022 uses 4 LED wavelengths to accurately read AUTION 10EA Stick test strips which are impregnated with chemicals to induce the reactions shown below upon contact with particular analytes in urine. Three (3) of the wavelengths read the analyte interaction while the fourth wavelength is used for color tone detection and correction.
Glucose: Glucose oxidase reaction. GOD → Gluconic acid + H₂O₂ Glucose POD H2O2 + 4-AAP + 1-Naphthol-3,6-disulfonic acid > Quinone imine dye (purple color) oxidation Protein: Protein-error reaction. Protein + pH indicator _ acid > pH indicator changes to a cyan color Bilirubin: Azo-coupling reaction. acid 2-Methyl-5-nitroaniline + Sodium nitrite Diazonium salt diazo reaction acid Bilirubin + Diazonium salt Azo dye (reddish brown color) coupling reaction Urobilinogen: Azo-coupling reaction. acid Urobilinogen + Diazonium salt > Azo dye (reddish brown color) coupling reaction pH: pH indicator. ► ► mixed pH indicator shows range of colors H+ + mixed pH indicator covering the urinary pH range (yellow - cyan color) Specific Gravity: Cation extraction. cation extraction Cation + D-2-EHPA + pH indicator color reaction of pH indicator (cyan - yellow color) Blood: Activity measurement of pseudoperoxidase in hemoglobin. hemoglobin > H2O + Cumene + Oxidation dye (cyan color) CHP + TMBZ pseudoperoxidase action Ketones: Legal reaction. alkaline Ketones + Sodium nitroprusside > Ketones complex (purple color) Nitrite: Griess reaction. acid Nitrite + Sulfanilamide -> Diazo-compound + NEDA-2HCl acid Azo dye (pink color) coupling reaction Leukocytes: Measurement of leukocyte esterase activity. TAI esterase from leukocytes - Indoxyl + MMB -______________________________________________________________________________________________________________________________________________________________________________ hydrolysis
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Performance Characteristics
Bench testing and clinical testing were done in order to verify that the above differences are minor in nature and do not affect the overall performance, safety, or effectiveness of the proposed device compared to the predicate device.
Precision Results
Each analyte was tested at 3 clinical sites using 3 operators on 3 devices for a minimum of 20 days. Three (3) levels of quality controls were used to attain results at negative, midlevel positive and high-positive analyte ranges. Two (2) levels of commercial controls were used to obtain the 3 levels, using dilutions and spiking materials as needed to obtain the highest and mid-level controls for testing of all the analyte ranks.
| Table 3: Precision Results | ||
|---|---|---|
| Repeatability | Reproducibility | |||
|---|---|---|---|---|
| Analyte | Exact match | |||
| % | +/- 1 | |||
| Color Block | ||||
| % | Exact match | |||
| % | +/- 1 | |||
| Color Block | ||||
| % | ||||
| Glucose | 98% | 100% | 99% | 100% |
| Protein | 100% | 100% | 100% | 100% |
| Bilirubin | 99% | 100% | 99% | 100% |
| Urobilinogen | 99% | 100% | 100% | 100% |
| pH | 98% | 100% | 99% | 100% |
| Specific | ||||
| gravity | 96% | 100% | 97% | 100% |
| Blood | 99% | 100% | 100% | 100% |
| Ketones | 100% | 100% | 100% | 100% |
| Nitrite | 100% | 100% | 100% | 100% |
| Leukocytes | 100% | 100% | 100% | 100% |
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Comparison Study Results
A Method Comparison study was performed at 3 sites to compare the AUTION ELEVEN Semi-Automated Urinalysis System against 2 commercially available urinalysis predicates, 1 semi-automated urine analyzer was used for specific gravity comparison and one fully-automated urine analyzer was used to compare all the rest of the analytes.
Each site collected urine patient samples from their clinical laboratory or obtained them from nearby hospitals. Urine samples were collected and refrigerated within 2 hours of collection, for up to 24 hours of refrigeration prior to clinical study testing. For inclusion into the study, the samples collected had to be positive for at least one of the chemistry analytes present on the AUTION Stick 10EA urinalysis strip
Data from each site was combined for the analysis. Accuracy (percent agreement) results are shown below.
| Analyte | Number of
samples | Percent
Positive
Samples | Exact
Agreement
with Predicate | 95% CI | Agreement
within ± 1
color block |
|------------------|----------------------|--------------------------------|--------------------------------------|-------------|----------------------------------------|
| Glucose | 2199 | 16% | 98% | 97.5 - 98.6 | 100% |
| Protein | 563 | 56% | 86% | 83.2 - 89.1 | 100% |
| Bilirubin | 2323 | 8% | 100% | 99.1 - 99.7 | 100% |
| Urobilinogen | 2308 | 12% | 98% | 94.7 - 96.4 | 100% |
| pH | 2307 | 100% | 89% | 88.3 - 90.9 | 100% |
| Specific Gravity | 548 | 100% | 81% | 77.9 - 84.6 | 99% |
| Blood | 548 | 45% | 92% | 89.2 - 94 | 100% |
| Ketones | 2221 | 28% | 96% | 95.1 - 96.8 | 100% |
| Nitrite | 2209 | 6% | 99% | 99.6 - 98.8 | 100% |
| Leukocyte | 548 | 40% | 92% | 89 - 93.8 | 100% |
Table 4: Method Comparison Results
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Interfering Substances
Table 5: Interferent Results
| Analyte | Interferent | Concentration | Result |
|---|---|---|---|
| Glucose | Ascorbic acid | >50 mg/dL | False negative |
| (-2 to -3 color block change) | |||
| Glucose | pH | 20 mg/dL | False positive |
| (+2 color block change) | |||
| Bilirubin | Urobilinogen | >8 mg/dL | False positive |
| (+1 color block change) | |||
| Urobilinogen | Bilirubin | >3 mg/dL | False positive |
| (+1 color block change) | |||
| pH | N/A | ||
| Specific Gravity | pH | 300 mg/dL | Elevated |
| (+2 color block change) | |||
| Ammonium chloride | >200 mg/dL | Elevated | |
| (+2 color block change) | |||
| Blood | Substances such as | ||
| MESNA that contain | >50 mg/dL | False negative | |
| (-3 color block change) | |||
| Ketones | Substances such as | ||
| MESNA that contain | >5 mg/dL | False positive | |
| (+2 to +5 color block change) | |||
| Nitrite | N/A | ||
| Leukocytes | Glucose | >200 mg/dL | False negative |
| (-2 color block change) | |||
| Albumin | >300 mg/dL | False negative | |
| (-2 color block change) | |||
| pH | 1.030 | 1.028 | |
| Blood | - | NEG | 0 |
| ± | 0.03 | 0.023 | |
| 1+ | 0.06 | 0.05 | |
| 2+ | 0.20 | 0.18 | |
| 3+ | 1.00 | 0.9 | |
| Ketone | - | NEG | 0 |
| ± | 5 | 4 | |
| 1+ | 10 | 7.5 | |
| 2+ | 40 | 30 | |
| 3+ | 80 | 70 | |
| 4+ | 150 | 130 | |
| Nitrite | - | N/A | 0 |
| 1+ | N/A | 0.075 | |
| 2+ | N/A | 0.3 | |
| Leukocytes | N/A | NEG | 0 |
| 25 | 25 | ||
| 75 | 50 | ||
| 250 | 180 | ||
| 500 | 390 | ||
| Analyte | Qualitative | ||
| Rank | Semi- | ||
| Quantitative | |||
| Rank | Concentration | ||
| /Level Tested | Exact Match | ± 1 Color | |
| Block | |||
| Glucose | - | NEG | 0 mg/dL |
| ± | 30 | 45 mg/dL | |
| 1+ | 70 | 85 mg/dL | |
| 2+ | 150 | 170 mg/dL | |
| 3+ | 300 | 340 mg/dL | |
| 4+ | 1000 | 2700 mg/dL | |
| Protein | - | NEG | 0 mg/dL |
| ± | 10 | 15 mg/dL | |
| 1+ | 30 | 30 mg/dL | |
| 2+ | 100 | 120 mg/dL | |
| 3+ | 300 | 480 mg/dL | |
| 4+ | 1000 | 1000 mg/dL | |
| Bilirubin | - | NEG | 0 mg/dL |
| 1+ | 0.5 | 1.5 mg/dL | |
| 2+ | 2 | 3 mg/dL | |
| 3+ | 6 | 6 mg/dL | |
| 4+ | 14 | 14 mg/dL | |
| Urobilinogen | NORM | NORM | normal |
| 1+ | 2 | 3 mg/dL | |
| 2+ | 4 | 5 mg/dL | |
| 3+ | 8 | 10 mg/dL | |
| 4+ | 16 | 20 mg/dL | 100% (21/21) |
| pH | N/A | 5 | 5.0 |
| 5.5 | 5.5 | ||
| 6 | 6.0 | ||
| 6.5 | 6.5 | ||
| 7 | 7.0 | ||
| 7.5 | 7.5 | ||
| 8 | 8.0 | ||
| 8.5 | 8.4 | ||
| 9 | 9.0 | ||
| Specific | |||
| Gravity | N/A | 1.030 | 1.035 |
| Analyte | Qualitative | ||
| Rank | Semi- | ||
| Quantitative | |||
| Rank | Concentration | ||
| /Level Tested | Exact Match | ± 1 Color | |
| Block | |||
| Blood | - | NEG | 0 mg/dL |
| ± | 0.03 | 0.03 mg/dL | |
| 1+ | 0.06 | 0.08 mg/dL | |
| 2+ | 0.20 | 0.6 mg/dL | |
| 3+ | 1.00 | 1.3 mg/dL | |
| Ketone | - | NEG | 0 mg/dL |
| ± | 5 | 5 mg/dL | |
| 1+ | 10 | 15 mg/dL | |
| 2+ | 40 | 60 mg/dL | |
| 3+ | 80 | 120 mg/dL | |
| 4+ | 150 | 240 mg/dL | |
| Nitrite | - | N/A | 0 mg/dL |
| 1+ | 0.1 mg/dL | ||
| 2+ | 0.8 mg/dL | ||
| Leukocytes | N/A | NEG | 0 Leu/µL |
| 25 | 25 Leu/µL | ||
| 75 | 75 Leu/µL | ||
| 250 | 250 Leu/µL | ||
| 500 | 520 Leu/µL |
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Linearity Results
Table 7: Linearity
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Proposed Labeling
Labeling adequately communicates device intended use, safety precautions and directions for use. It satisfies 21 CFR Part 809.10 for in vitro diagnostic devices.
Conclusion
Bench Testing
Bench testing evaluations were used to verify performance characteristics of the AUTION ELEVEN Semi-Automated Urinalysis System. Bench testing evaluations included: linearity, sensitivity, interfering substances, detection limit/specificity, electrical compatibility and safety, radiofrequency compatibility, device software validation, and test strip shelf life and stability. In all instances, results from bench testing met pre-determined acceptance criteria and support a determination of substantial equivalence.
Clinical Testing
A precision study was performed on each analyte across 3 sites with 3 operators (1 per site) and 3 devices using 3 levels of quality control solutions per analyte to evaluate repeatability and reproducibility. A Method Comparison study was performed at a predetermined number of sites with 8395 tests of individual analytes including both natural and spiked samples. The overall conclusion from the clinical evaluation is that the results are
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acceptable and support a determination of substantial equivalence without additional risk to safety and efficacy.
Based upon the intended use, comparison with the previously cleared predicate devices, technology similarities, and bench and clinical data, the AUTION ELEVEN Semi-Automated Urinalysis System is substantially equivalent to the predicate devices, AUTION MAX AX-4030 Fully-Automated Urinalysis System.