(31 days)
Not Found
No
The document describes an "algorithm" for converting sensor output to semi-quantitative colors, but there is no mention of AI, ML, or any related concepts like training data or complex model architectures typically associated with AI/ML. The focus is on replacing end-of-life components and updating a standard algorithm.
No
The device is an in vitro diagnostic (IVD) system used to automate urine chemistry analysis. It provides diagnostic information but does not directly treat or alleviate a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The iChem® VELOCITY™ automated urine chemistry system is an in vitro diagnostic device..." and "These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function."
No
The device description explicitly mentions hardware components like the Strip Reader Module (SRM), Color/Clarity Module (CCM), and Specific Gravity Module (SGM), which utilize light reflectance, transmittance, and refractive index measurements. The submission is for a design change to the CCM, involving replacing hardware components (color sensor and scatter light source) and updating an algorithm. This indicates it is a system with both hardware and software, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The iChem® VELOCITY™ automated urine chemistry system is an in vitro diagnostic device..." and "Tests performed using the iChemVELOCITY are intended for clinical laboratory and in vitro diagnostic use only."
- Nature of the Test: The device analyzes chemical and physical constituents of urine, which is a biological sample taken from the body. This type of analysis performed outside of the body is the definition of an in vitro diagnostic test.
- Intended Use: The intended use is to "aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function," which are all medical conditions. IVDs are used to provide information for diagnosis.
- Care Setting: The device is intended for use in a "clinical laboratory," which is a typical setting for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The iChem® VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem® VELOCITY ™ Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity.
iChemVELOCITY strips are intended for use only with the iChem Velocity analyzer. In particular, they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.
These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChemVELOCITY are intended for clinical laboratory and in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
JIL, JIO, CDM, JJB, JIN, JIR, JMT, LJX, CEN, JRE, JMA, KQO
Device Description
The iChemVELOCITY is an automated urine chemistry system performing measurements of defined physical and chemical constituents in urine. The system utilizes iChemVELOCITY urine chemistry test strips which are read in the Strip Reader Module (SRM) by measuring light reflectance, in addition the iChemVELOCITY measures color and clarity using light transmittance through Color/Clarity Module (CCM) and specific gravity using refractive index through Specific Gravity Module (SGM).
The subject of this submission is a design change to the Color/Clarity Module (CCM) of the Color/Clarity/Specific Gravity Module (CGM) subassembly of the iChemVELOCITY. The CCM measures the color and clarity of a urine sample using transmitted and scattered light, incident on a color sensor. An algorithm then converts the output of the different channels of the sensor into semi-quantitative colors. The CCM is being changed to replace end-of-life components (color sensor and scatter light source) and update the color detection algorithm.
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
Tests performed using the iChemVELOCITY are intended for clinical laboratory and in vitro diagnostic use only.
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)
Performance testing of the iChemVELOCITY with the redesigned CCM was conducted to ensure that the system as a whole demonstrates equivalent performance to the predicate design. This testing included:
- Method Comparison
- Precision
Method Comparison Results Summary for Color:
- Colorless: 100.0% Exact match, 100.0% ± 1 Block match
- Straw: 36% Exact match, 100.0% ± 1 Block match
- Yellow: 92% Exact match, 100.0% ± 1 Block match
- Amber: 60.0% Exact match, 100.0% ± 1 Block match
- Red: 100.0% Exact match, 100.0% ± 1 Block match
- Blue: 100.0% Exact match, 100.0% ± 1 Block match
Method Comparison Results Summary for Clarity:
- Clear: 100.0% Exact match, 100.0% ± 1 Block match
- Slightly Cloudy: 29.2% Exact match, 100.0% ± 1 Block match
- Cloudy: 61.1% Exact match, 97.2% ± 1 Block match
- Turbid: 97.0% Exact match, 100.0% ± 1 Block match
Precision Results Summary (Sample Size: 240 for each test level):
Color Categories:
- Colorless: 100% Exact agreement, 100% ±1 block agreement
- Straw: 99.2% Exact agreement, 100% ±1 block agreement
- Yellow: 100% Exact agreement, 100% ±1 block agreement
- Amber: 100% Exact agreement, 100% ±1 block agreement
- Red: 98.8% Exact agreement, 99.6% ±1 block agreement
- Blue: 100% Exact agreement, 100% ±1 block agreement
Clarity Categories: - Clear: 100% Exact agreement, 100% ±1 block agreement
- Slightly Cloudy: 95.0% Exact agreement, 100% ±1 block agreement
- Cloudy: 100% Exact agreement, 100% ±1 block agreement
- Turbid: 100% Exact agreement, 100% ±1 block agreement
Key Results: All testing successfully passed the acceptance criteria, and the test results demonstrated equivalence to the predicate. Testing results verified that the iChemVELOCITY with the redesigned CCM produced results within the performance characteristics of the device and did not negatively impact the user experience.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Exact match, ± 1 Block, Exact agreement, ±1 block agreement. Specific values are listed in the "Summary of Performance Studies" section.
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
§ 862.1340 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2017
IRIS DIAGNOSTICS, A DIVISION OF IRIS INTERNATIONAL NANCY NADLER DIRECTOR, REGULATORY AFFAIRS 9172 ETON AVE CHATSWORTH, CA 91311
Re: K171083
Trade/Device Name: iChemVELOCITY Automated Urine Chemistry System Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL, JIO, CDM, JJB, JIN, JIR, JMT, LJX, CEN, JRE, JMA, KQO Dated: April 10, 2017 Received: April 11, 2017
Dear Nancy Nadler:
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 (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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
Kellie B. Kelm -S
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
2
Indications for Use
510(k) Number (if known) K171083
Device Name
iChem®VELOCITY™ Automated Urine Chemistry System
Indications for Use (Describe)
The iChem® VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem® VELOCITY ™ Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iO®200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilingen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity.
iChemVELOCITY strips are intended for use only with the iChem Velocity analyzer. In particular, they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.
These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChemVELOCITY are intended for clinical laboratory and in vitro diagnostic use only.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the text "BECKMAN" on the first line and "COULTER" on the second line. The text is in a bold, sans-serif font.
iris
510(k) Summary for iChem®VELOCITY™ Automated Urine Chemistry System – CGM Design Change
510(k) Owner / Submitter Information
Nancy Nadler Director, Regulatory Affairs Iris Diagnostics, a Division of Iris International 9172 Eton Avenue Chatsworth, California 91311 Telephone: 305-380-4191 Fax: 786-639-4191 Email: nancy.nadler@beckmancoulter.com
Date Submitted: April 10, 2017
Device Information
Trade Name: iChem® VELOCITY™ Automated Urine Chemistry System Common Name: Urine Chemistry Analyzer
| Classification Name | Product
Code | Device
Class | Regulation
Number |
|------------------------------------------------------------------------|-----------------|-----------------|----------------------|
| Urinary glucose (non-quantitative) test
system | JIL | II | 21 CFR§862.1340 |
| Occult blood test | JIO | II | 21 CFR§864.6550 |
| Urinary urobilinogen (non-
quantitative) test system | CDM | I | 21 CFR§862.1785 |
| Urinary bilirubin and its conjugates
(non-quantitative) test system | JJB | I | 21 CFR§862.1115 |
| Ketones (non-quantitative test system) | JIN | I | 21 CFR§862.1435 |
| Urinary protein or albumin (non-
quantitative) test system | JIR | I | 21 CFR§862.1645 |
| Nitrite (non-quantitative) test system | JMT | I | 21 CFR§862.1510 |
| Leukocyte peroxidase test | LJX | I | 21 CFR§864.7675 |
| Urinary pH (non-quantitative) test
system | CEN | I | 21 CFR§862.1550 |
| Refractometer for Clinical Use | JRE | I | 21 CFR§862.2800 |
| Ascorbic Acid Test System | JMA | I | 21 CFR§862.1095 |
| Automated Urinalysis System | KOO | I | 21 CFR§862.2900 |
Table 1: Regulatory Information
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Image /page/4/Picture/0 description: The image contains the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the words "BECKMAN" and "COULTER" stacked on top of each other in black, bold font. The logo is simple and modern, with a focus on the company's name.
| Candidate | Predicate | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|---|
| iChemVELOCITY | ||||
| with re-designed | ||||
| CGM | iChemVELOCITY | Iris Diagnostics, | ||
| a Division of Iris | ||||
| International Inc | K101852 | 03/23/2011 |
Predicate Device Information
Device Description
The iChemVELOCITY is an automated urine chemistry system performing measurements of defined physical and chemical constituents in urine. The system utilizes iChemVELOCITY urine chemistry test strips which are read in the Strip Reader Module (SRM) by measuring light reflectance, in addition the iChemVELOCITY measures color and clarity using light transmittance through Color/Clarity Module (CCM) and specific gravity using refractive index through Specific Gravity Module (SGM).
The subject of this submission is a design change to the Color/Clarity Module (CCM) of the Color/Clarity/Specific Gravity Module (CGM) subassembly of the iChemVELOCITY. The CCM measures the color and clarity of a urine sample using transmitted and scattered light, incident on a color sensor. An algorithm then converts the output of the different channels of the sensor into semi-quantitative colors. The CCM is being changed to replace end-of-life components (color sensor and scatter light source) and update the color detection algorithm.
Intended Use/Indications for Use:
The iChem® VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem® VELOCITY TM Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity.
These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function.
iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular, they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.
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Image /page/5/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red oval shape with two white curved lines inside, placed to the left of the company name. The text "BECKMAN COULTER" is written in bold, black letters, with "BECKMAN" on the top line and "COULTER" on the bottom line.
Tests performed using the iChemVELOCITY are intended for clinical laboratory and in vitro diagnostic use only.
Comparison to Predicate
The design change applied to the CCM is to replace the color sensor Taos TCS230 with Taos TCS3200 color sensor, along with the scatter LED due to end-of-life of the components. These components were chosen because of their similar characteristics to the components they replace. In addition to the electronic components, new firmware has been written and installed on the CCM's microprocessor to control the new components and to update the CCM algorithm.
Color and clarity result categories are not changed with this design change, and the change is fit and functionally compatible with the subassembly as cleared in K101852. The CCM change is intended to provide a substantially equivalent subassembly with equivalent output to the original design as cleared in K101852.
Similarities and Differences between iChemVELOCITY as cleared in K101872 and the iChemVELOCITY with the redesigned CCM are shown in the table below.
| | iChemVELOCITY Analyzer
K101852 (cleared on 3/23/2011) | Proposed Device
iChemVELOCITY with
Redesigned CCM |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The iChem® VELOCITY™
automated urine chemistry system is
an in vitro diagnostic device used to
automate the urine chemistry
analysis profile using iChem®
VELOCITY ™ Urine Chemistry
Strips. The iChemVELOCITY can
be used as a stand-alone system, as
well as in an iQ®200 Series system,
a configuration given the proprietary
name iRICELL™ as it is designed to
be hardware and software
compatible with iQ200 Series
systems. It produces quantitative
results for specific gravity; semi-
quantitative results for glucose,
blood, leukocyte esterase, bilirubin,
urobilinogen, pH, protein, ketones
and ascorbic acid; and qualitative | Same |
| | iChemVELOCITY Analyzer
K101852 (cleared on 3/23/2011) | Proposed Device
iChemVELOCITY with
Redesigned CCM |
| | results for nitrites, color and clarity.
iChemVELOCITY strips are
intended for use only with the
iChemVELOCITY analyzer. In
particular, they are not intended for
visual reading. The
iChemVELOCITY is not intended to
be used as a Point of Care (POC)
analyzer. | |
| | These measurements are used to aid
in the diagnosis of metabolic
disorders, kidney function
anomalies, urinary tract infections,
and liver function. Tests performed
using the iChemVELOCITY are
intended for clinical laboratory and
in vitro diagnostic use only. | |
| Specimen
analyzed | Urine collected in cup or other
container, and transferred to a tube for
sampling onto iChemVELOCITY test
strips. | Same |
| Method of
Operation | Color change on the pads of the
iChemVELOCITY strips are analyzed
for percent reflectance and converted to
results through an algorithm
Urine color and clarity are obtained by
measuring absorbance or scattering of
white light through a flowcell.
Intensities of RGB wavelengths are
measured with a solid-state
photodetector array.
Specific gravity is measured by
determining the refractive index of the
specimen | Same |
| Energy Source | AC power is converted to DC by an
internal switching mode power supply | Same |
| | iChemVELOCITY Analyzer
K101852 (cleared on 3/23/2011) | Proposed Device
iChemVELOCITY with
Redesigned CCM |
| Color Sensor | Taos TCS230 | Taos TCS3200
Due to an obsolescence of the
sensor |
| Scatter LED | Luxeonstar/Lumileds LXHL-LW3C | Luxeonstar/Lumileds SR-01-
WC100 |
| Microcontroller | PIC 18F25 | Same |
| Board
communications | UART | Same |
| Firmware | The CCM measures the light intensity
in RGB channels. Then it corrects each
channel using iChemVELOCITY wash
solution as a reference source. The
compensated RGB data is converted to
project in 2 dimensional HSL color
plane | Same method for the HSL color
space, however boundaries for
color bins were modified and an
Ohta Color plane was added to
refine color measurements along
the boundaries of the HSL
calculations. |
| Result format | Semi-quantitative results are presented
for color and clarity. Specifically: | Same |
| | Color - Red, Blue, Amber, Yellow,
Straw, and Colorless | |
| | Clarity - Turbid, Cloudy, Slightly
Cloudy, and Clear | |
Table 2: Comparison Between Proposed Device and Predicate Device
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Image /page/6/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circular symbol with two curved white lines inside, resembling an abstract representation of a wave or a double helix. To the right of the symbol, the words "BECKMAN" and "COULTER" are written in bold, black, sans-serif font, with "BECKMAN" on the top line and "COULTER" on the bottom line.
iris
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Image /page/7/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the company name "BECKMAN COULTER" in bold, black letters. The word "BECKMAN" is stacked on top of the word "COULTER".
Image /page/7/Picture/1 description: The image shows the word "Iris" in a stylized, sans-serif font. The letters are in a gray color, and the word is slightly slanted to the right. The "i" is lowercase, and the rest of the letters are also lowercase. The word appears to be a logo or brand name.
Substantial Equivalence Conclusion
In order to demonstrate substantially equivalent performance of the proposed device to the predicate device for this design change, verification studies were designed and performed to ensure that the fit of the CCM in the iChemVELOCITY remained unchanged, and that the function of the CCM produced equivalent results to the predicate design. All testing successfully passed the acceptance criteria, and the test results demonstrated equivalence to the predicate.
In addition, no new hazards were introduced with the implementation of this change and therefore safety associated with the operation of this device remains unchanged.
In summary, the iChemVELOCITY with the redesigned CCM is substantially equivalent to the predicate device in regard to safety, effectiveness, and performance characteristics.
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Image /page/8/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, resembling a stylized representation of a wave or a double helix. To the right of the circle, the words "BECKMAN" and "COULTER" are written in bold, black, sans-serif font, with "BECKMAN" on the top line and "COULTER" on the bottom line.
Summary of Performance Data
This design change is transparent to the user and does not alter any performance claims of the device. Various tests were conducted on the redesigned CCM to verify that fit and function of the subassembly did not impact the user experience or the performance characteristics of the iChemVELOCITY system. Verification studies were designed based on the risk analysis to verify that the proposed design performed better or equivalently to the predicate.
Performance testing of the iChemVELOCITY with the redesigned CCM was conducted to ensure that the system as a whole demonstrates equivalent performance to the predicate design. This testing included:
- o Method Comparison
- Precision o
Performance Test Summary
Table 3: Method Comparison Results Summary
| Comparator | |||||||
|---|---|---|---|---|---|---|---|
| Redesigned | |||||||
| CCM | Blue | 18 | |||||
| Red | 3 | 18 | |||||
| Amber | 5 | 18 | |||||
| Yellow | 11 | 61 | 9 | ||||
| Straw | 13 | ||||||
| Colorless | 18 | 12 | |||||
| Colorless | Straw | Yellow | Amber | Red | Blue | ||
| Exact match: | 100.0% | 36% | 92% | 60.0% | 100.0% | 100.0% | |
| ± 1 Block: | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
| Comparator | |||||
|---|---|---|---|---|---|
| Redesigned | |||||
| CCM | Turbid | 32 | |||
| Cloudy | 1 | 22 | 1 | ||
| Slightly Cloudy | 7 | 13 | |||
| Clear | 87 | 16 | 1 | ||
| Clear | Slightly | ||||
| Cloudy | Cloudy | Turbid | |||
| Exact match: | 100.0% | 29.2% | 61.1% | 97.0% | |
| ± 1 Block: | 100.0% | 100.0% | 97.2% | 100.0% |
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Image /page/9/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circle with two white curved lines inside, followed by the words "BECKMAN" in bold black letters above the word "COULTER" in bold black letters. To the left of the logo is a short black line.
| Color/Clarity | Test level | Number | | | % Exact
agreement | % ±1 block
agreement |
|---------------|-----------------|--------|----------------|-------------------|----------------------|-------------------------|
| | | Total | Exact
agree | ±1 block
agree | | |
| Color | Colorless | 240 | 240 | 240 | 100% | 100% |
| | Straw | 240 | 238 | 240 | 99.2% | 100% |
| | Yellow | 240 | 240 | 240 | 100% | 100% |
| | Amber | 240 | 240 | 240 | 100% | 100% |
| | Red | 240 | 237 | 239 | 98.8% | 99.6% |
| | Blue | 240 | 240 | 240 | 100% | 100% |
| Clarity | Clear | 240 | 240 | 240 | 100% | 100% |
| | Slightly Cloudy | 240 | 228 | 240 | 95.0% | 100% |
| | Cloudy | 240 | 240 | 240 | 100% | 100% |
| | Turbid | 240 | 240 | 240 | 100% | 100% |
Table 4: Precision Results Summary
Conclusion
Testing results verified that the iChemVELOCITY with the redesigned CCM produced results within the performance characteristics of the device and did not negatively impact the user experience.
The data presented in this Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution.
The testing results confirmed that the redesigned CCM was fit, functionally compatible and equivalent to the original CCM.
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.