iQ200 System: The iQ200 automated urine microscopy system is an in vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the iQ200 analyzer can be used as a stand-alone unit, or the results from the iQ200 analyzer can be combined with other urine chemistry results received from an LIS. It produces quantative or qualitative counts of all formed sediments present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist.

iChemVELOCITY Automated Urine Chemistry System: 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 Chemietry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 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 nitrite, color and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular, they are not intended for visual reading. The iChem VELOCITY 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 use and in vitro diagnostics use only.

Device Description

The iQ200 System auto-identifies and processes specimens in 10-position racks by mixing. sampling, and analyzing automatically. The iQ200 Series Automated Urine Microscopy system presents a specimen sandwiched between enveloping layers of lamina to a microscope coupled to a CCD (charge coupling device) video camera. This lamination positions the specimen exactly within the depth of focus and field of view of the objective lens of the microscope. The iQ200 System provides automatic sample handling for automated intelligent microscopy and automatic analyte classification for improved data reporting, presentation and management. Specimens are aspirated by an autosampler rather than poured manually. Individual particle images are isolated within each frame. The Auto-Particle Recognition (APR) software, uses size, shape, contrast and texture features to classify each image into one of 12 categories: RBCs, WBCs, WBC Clumps, Hyaline Casts, Unclassified Casts, Squamous Epithelial Cells, Non-squamous Epithelial Cells, Bacteria, Yeast, Crystals, Mucus and Sperm. Additionally, 27 predefined sub-classifications are available for identifying specific types of casts, crystals, non-squamous epithelial, dysmorphic, and others. Particle concentration is calculated using the number of particles images and the volume analyzed. User-defined release criteria are checked and results are sent to an operator review screen or directly uploaded to the LIS based on these criteria. Specimen results can be edited, imported, and exported.

The iQ Body Fluids Module is a software program that runs on the iQ Series Systems and automates body fluid sample handling, capturing particle images in a manner similar to that of the urinalysis application. The iQ200 Series System uses a CCD camera to capture images from each sample.

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. The device is a fully automated, computer-controlled urine chemistry analyzer intended for use only with iChemVELOCITY Urine Chemistry Strips for the measurement of ten urine chemistry analytes from the chemistry strip plus the measurement of specific gravity using an electronic refractometer assembly and the qualitative measurement of color and clarity by optical absorbance and scattering methods, respectively. 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.

The primary function of the iQ200 and iChemVELOCITY analyzers is to process samples and provide results to the workstation. The primary functions of the workstation are: user interface, system control, results processing, data storage, and external communications. The analyzers run embedded code on micro controllers and the workstation software runs Microsoft Windows 7 or Windows XP Operating System (OS). The workstation can be connected to: A printer for creating reports; A Laboratory Information System (LIS) for receiving test orders and releasing results.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Beckman Coulter iQ200 System and iChemVELOCITY Automated Urine Chemistry System.

Important Note: The provided document is a 510(k) Summary for a "Special 510(k)" submission. This type of submission is used when there are design modifications to a legally marketed device, and the modifications do not significantly alter the device's intended use or fundamental scientific technology. Therefore, the document focuses on demonstrating that the changes do not negatively impact the substantial equivalence to the original predicate device, rather than providing a full de novo performance study.

The primary change described is a software update (APUI software version 7.2) to address a duplicate specimen flagging issue and cybersecurity vulnerabilities.

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy for classification of urine sediment elements or chemistry analytes) for the iQ200 System or iChemVELOCITY Automated Urine Chemistry System, nor does it report new device performance metrics directly tied to the software update.

Instead, the submission states that: "These software design changes do not impact the intended use or performance claims of the iQ200 Automated Urine Microscopy and iChemVELOCITY Automated Urine Chemistry analyzers."

The "acceptance criteria" in this context are related to demonstrating that the software changes do not adversely affect the previously established performance of the predicate device.

The "reported device performance" from the original predicate device (K022774 for iQ200 and K101852 & K171083 for iChemVELOCITY) is implicitly upheld by the assertion that the new software does not change performance.

However, specific to the new software features (duplicate specimen flagging and cybersecurity), the following can be inferred as "acceptance criteria" and "reported performance":

Acceptance Criteria (Inferred from functionality)	Reported Device Performance (as per document)
Duplicate Specimen Detection: - Flag specimens with duplicate IDs and same Medical Record Number. - Flag specimens with duplicate IDs and different Medical Record Number. - Allow user-configurable time window (12-72 hours) for duplicate detection. - Hold results for operator review if a duplicate is flagged.	Duplicate Specimen Detection: - Software generates "DUPLICATE SPECIMEN ID (SAME MEDICAL RECORD NUMBER)" flag if condition met. - Software generates "DUPLICATE SPECIMEN ID (DIFFERENT MEDICAL RECORD NUMBER)" flag if condition met. - APUI software uses a user-configurable time window from 12 to 72 hours (default 12 hours). - Specimen result is held until operator review.
Cybersecurity Vulnerability Mitigation (Windows XP): - Address Bluekeep vulnerability. - Address WannaCry vulnerability.	Cybersecurity Update (Windows XP): - Vulnerability Assessment scan successfully performed. - Penetration test successfully done; XP OS patched for most common Bluekeep and WannaCry viruses. - Source code review successfully done, vulnerabilities triaged.
Cybersecurity Vulnerability Mitigation (Windows 7): - Not susceptible to Bluekeep. - Not susceptible to WannaCry.	Cybersecurity Update (Windows 7): - Does not have Bluekeep vulnerability (Remote Desktop Protocol ports closed). - Not susceptible to WannaCry (firewall enabled, communication ports closed to external connections).
Maintenance of Intended Use and Performance Claims: - Software changes do not alter intended use. - Software changes do not impact existing performance claims.	Maintenance of Intended Use and Performance Claims: - "No change" to intended use for all listed predicate devices. - "These software design changes do not impact the intended use or performance claims..."

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a "test set" in the traditional sense for evaluating the primary diagnostic performance of the device, as this is a software update to an already cleared device.

For the duplicate specimen detection feature, the document describes the functionality of the software (how it flags duplicates) but does not provide details of a specific test set (number of samples, etc.) used to validate this functionality. The validation would likely involve software testing to confirm correct flagging under various conditions (same ID/same MRN, same ID/different MRN, within/outside time window). Data provenance for such internal software testing is not provided.

For the cybersecurity updates, "Vulnerability Assessment scan" and "penetration test" were mentioned, but no sample size (e.g., number of systems tested) or data provenance (country of origin, retrospective/prospective) is specified. These are typically internal verification activities rather than clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable in this context. This submission focuses on a software update to an already cleared device, and the changes are not related to the classification or diagnosis of specific analytes that would require expert ground truth.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this submission does not detail a clinical test set that required expert adjudication for ground truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. The device (iQ200 System) is an automated cell counter and the iChemVELOCITY is an automated urine chemistry system. The software update is on the Analytical Processing User Interface (APUI) and cybersecurity, not on a feature that directly assists human readers in interpretation where an "AI vs. human" comparison would be relevant. The iQ200 does produce particle images and allows human review and override, but the modifications described here do not pertain to that specific human-in-the-loop performance measurement.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

While the iQ200 System has "Auto-Particle Recognition (APR) software" that classifies images into categories, the document for this specific 510(k) does not detail standalone performance testing for the current software version's classification algorithm. The original clearance for the predicate device would have established this. This submission mainly addresses the APUI (user interface) functionality and cybersecurity.

7. The Type of Ground Truth Used

For the software functionalities specifically mentioned (duplicate specimen flagging, cybersecurity), the ground truth would be based on:

For Duplicate Specimen Flagging: The actual specimen IDs, Medical Record Numbers, and timestamps in a simulated or real system environment, and whether the software correctly identifies and flags duplicates based on its configured rules.
For Cybersecurity: Known vulnerabilities (e.g., Bluekeep, WannaCry technical specifications) and standard cybersecurity testing methodologies to verify patch effectiveness.

For the underlying diagnostic performance of the iQ200 (urine sediment analysis) and iChemVELOCITY (urine chemistry), the ground truth for their original clearances would have been clinical reference methods, expert microscopy, and laboratory-confirmed results (pathology, etc.), but this is not detailed in this particular submission for the software update.

8. The Sample Size for the Training Set

Not applicable. This document describes a software update to an existing device, not the development of a new AI algorithm that would require a training set in the machine learning sense. The "Auto-Particle Recognition (APR) software" in the iQ200 system would have had a training set for its initial development and clearance, but details of that are not provided here, as this submission is for a modification.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no new training set is described for this software update. For the original APR software (if it involves machine learning), ground truth would typically have been established by expert consensus or reference laboratory methods for classifying urine sediment particles.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

July 2, 2021

Beckman Coulter, Inc. Marisa Pugliese Staff Regulatory Affairs Specialist 11800 SW 147th Avenue Miami, Florida 33196

Re: K210127

Trade/Device Name: iQ200 System, iChemVELOCITY Automated Urine Chemistry System Regulation Number: 21 CFR 864.5200 Regulation Name: Automated Cell Counter Regulatory Class: Class II Product Code: LKM, KQO, GKL, JIL Dated: January 15, 2021 Received: January 19, 2021

Dear Marisa Pugliese:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lea Carrington Director Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210127

Device Name iQ200 System iChemVELOCITY Automated Urine Chemistry System

Indications for Use (Describe)

iQ200 System:

The iQ200 automated urine microscopy system is an in vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the iQ200 analyzer can be used as a stand-alone unit, or the results from the iQ200 analyzer can be combined with other urine chemistry results received from an LIS. It produces quantative or qualitative counts of all formed sediments present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist.

iChemVELOCITY Automated Urine Chemistry System:

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 Chemietry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 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 nitrite, color and clarity.

iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular, they are not intended for visual reading. The iChem VELOCITY 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 use and in vitro diagnostics 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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510(k) Summary for Special 510(k) of the iO200 System and iChemVELOCITY Automated Urine Chemistry

510(k) Owner / Submitter Information

Company Name: Beckman Coulter Inc. Address: 11800 SW 147th Ave., Miami, FL 33196 Phone #: (305) 380-3002 Fax #: (786) 639-3002 Contact Person: Marisa Pugliese Email Address: mpugliese@beckman.com

Date Submitted:

January 15, 2021

Device Information:

Trade Name: iO200 System Classification: Class II Classification Name: Automated Cell Counter per 21 CFR 864.5200 Product Code: LKM; KQO; GKL Panel: Hematology

Trade Name: iChemVELOCITY Automated Urine Chemistry Classification: Class I Classification Name: Automated Urinalysis System, per 21 CFR 862.2900 Product Code: JIL Subsequent Product Codes: CDM, CEN, JIN, JIO, JIR, JJB, JMA, JMT, JRE, KQO, LJX Panel: Clinical Chemistry

Predicate Device Information:

Predicate Product	510(k) Number	Date Cleared	Classification	21 CFR	Product Code
iQ200 System	K022774	Oct. 21, 2002	Class IIClass I	864.5200862.2900	LKMKQO
iQ200 Urine AnalyzerBody Fluids Module	K050235	Mar. 23, 2005	Class II	864.5200	GKL
iQ200 System withLamina Cradle	K093861	Feb. 05, 2010	Class IIClass I	864.5200862.2900	LKMKQO
iQ200 Urine AnalyzerBody Fluids Module(The addition ofSynovial Fluid)	K091539	Aug. 31, 2010	Class II	864.5200	GKL
iChemVELOCITYAutomated UrineChemistry	K101852	Mar. 23, 2011	Class I	862.2900	KQO

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iChemVELOCITYAutomated UrineChemistry	K171083	May 12, 2017	Class IIClass I	862.1340862.2900	JILKQO
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iQ200 System and iChemVELOCITY Urinalysis System

This CBE (Changes Being Effected) 510(k) submission is due to system software changes to be implemented as part of the corrective action for a field action initiated by BEC in Z-0913-2020 and Z-0914-2020 reported on April 15, 2020.

The software change is for the iQ200 System and iChemVELOCITY Automated Urine Chemistry systems with its Analysis Processor User Interface or APUI software version 7.2 for Windows7 and XP Operating Systems.

Device Description:

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an electronic refractometer assembly and the qualitative measurement of color and clarity by optical absorbance and scattering methods, respectively. 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.

· A printer for creating reports
· A Laboratory Information System (LIS) for receiving test orders and releasing results.

Design Change Description

The modification prompting a new submission is an update to the iQ200 and iChemVELOCITY APUI software included in version 7.2 (for Windows 7 and XP Operating System). It contains the following changes:

If a duplicate specimen is detected by the APUI software one of the two flags will be generated:

Flag 1: If duplicate specimen ID is found with the same Medical Record Number, then software will flag the result as "DUPLICATE SPECIMEN ID (SAME MEDICAL RECORD NUMBER)".

Flag 2: If the duplicate specimen ID found has a different Medical Record Number, then software will flag the result as "DUPLICATE SPECIMENT ID (DIFFERENT MEDICAL RECORD NUMBER)".

If either of these flags appear, the specimen result will be held until the operator reviews the result. The operator will follow labelling instructions to resolve the flag.

APUI software uses a time window to determine whether a duplicate specimen is presented to the analyzer. This time window can be configured by the user. Allowable values range from 12 to 72 hours. The default value for the time window is 12 hours.

For example, if the user configures the time window as 24 hours, then, APUI will flag a specimen as duplicate, if it's ran within 24 hours of another specimen with the same identifier.

The upper limit for the review time frame is consistent with the shelf life of preservative tubes used with urine sample which is 72 hours. Based on this fact, an operator using preservative tubes can run the chemistry and continue on to the microscopy at a later time while still maintaining the urine sample integrity. When a specimen is presented and processed, the

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system will scan the database for specimens with the same identifier. Beyond the 72 hours timeframe, a specimen ID can be re-used and the system will not flag for a duplicate ID. The lower limit for the review timeframe is designated to align with the possibility that high volume laboratories can re-use the specimen ID more frequently based on the laboratory SOPs. Section 10 will provide further details on software workflow.

Cybersecurity Update

Included as part of this software modification is an update to the Windows XP Operating System (OS) cybersecurity to address Bluekeep and WannaCry vulnerabilities.

The following Cybersecurity tests were done on Windows XP Operating System.

1. Vulnerability Assessment scan was successfully performed.
1. A penetration test was successfully done by Beckman Coulter. Based on the test results, XP Operating System was patched for the most common Bluekeep and WannaCry viruses.
- Bluekeep is a security vulnerability that was discovered in Microsoft's Remote . Desktop Protocol implementation which allows for the possibility of remote code execution.
- . WannaCry is a ransomware attack that targeted Windows XP computers by encrypting data and demanding ransom payment in the Bitcoin cryptocurrency.

A source code review was successfully done for both Window XP and Window 7 by Beckman Coulter. Vulnerabilities reported by this tool have been triaged.

Reports for the above scans are available upon request.

Windows 7 Operating System does not have Bluekeep vulnerability since all the Remote Desktop Protocol ports are closed by the OS image.

Windows 7 Operating System is not susceptible to WannaCry ransomware attack since the OS image has a firewall that cannot be disabled, and communication ports are closed to external connections.

iQ200 and iChemVelocity analyzers have a layered approach for cybersecurity. These systems are isolated from outside networks. In addition, both Operating Systems has access controls for users to prevent unauthorized use.

Intended Use/Indications for Use:

iQ200 System (K022774) Intended Use:

The iQ200 automated urine microscopy system is an in vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the iQ200 analyzer can be used as a stand-alone unit, or the results from the iO200 analyzer can be combined with other urine chemistry results received from an LIS, It produces quantitative or qualitative counts of all formed sediment elements present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for

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auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist.

Note: There is no change to the system's intended use as a result of this software design change.

iO Body Fluids Module (K050235) Intended Use:

The iQ Body Fluids Module is an in-vitro diagnostic device used by a trained human observer to examine and count red blood cells and other nucleated cells in cerebrospinal fluid, and serous fluids.

Note: There is no change to the intended use as a result of this software design change.

iQ200 System with Lamina Cradle (K093861) Intended Use:

The iQ Lamina Cradle is a new accessory to be used with the iQ200 Series of Urine Microscopy Analyzers (K022774). The iO 200 System is an in-vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the iQ 200 Analyzer can be used as a stand-alone unit, or the results from the iQ 200 Analyzer can be combined with other urine chemistry results received from an LIS. It produces quantitative or qualitative counts of all formed sediment elements present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist.

Note: There is no change to the system's intended use as a result of this software design change.

iQ200 Urine Analyzer Body Fluids Module (The addition of Synovial Fluid)

The iQ200 Urine Analyzer Body Fluids Module for use with synovial fluid is an additional use for the iQ200 Urine Analyzer (K022774). The iO200 Urine Analyzer Body Fluids Module is an invitro diagnostic device used by an appropriately trained laboratory user to examine and count red blood cells and nucleated cells in cerebrospinal fluid, serous fluids and synovial fluid. This module is a capability added to the iO0200 Urine Analyzer.

Note: There is no change to the system's intended use as a result of this software design change.

iChemVELOCITY Automated Urine Chemistry System (K101852 & K171083) Intended Use:

The iChemVELOCITY automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 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

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gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrite, 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.

Note: There is no change to the system's intended use as a result of this software design change.

Comparison to Predicate:

The design changes applied to the iQ200 System and iChemVELOCITY analyzers serve as additional mitigations to new risk control measures to the potential failure mode identified in the root cause analysis of the field action that initiated these changes.

These software design changes do not impact the intended use or performance claims of the iO200 Automated Urine Microscopy and iChemVELOCITY Automated Urine Chemistry analyzers.

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Device Comparison Table:

Performance andCharacterization	IQ200 System – K022774 (Cleared Oct. 21,2002), K050235 (Cleared Mar. 23, 2005),K093861 (Cleared Feb. 05, 2010), K091539(Cleared Aug. 31, 2010)	Proposed Device
Intended Use	The iQ200 System is an in-vitro diagnosticdevice used to automate the complete urinalysisprofile, including urine test strip chemistry paneland microscopic sediment analysis. Optionally,the iQ200 Analyzer can be used as a stand-aloneunit, or the results from the iQ200 analyzer canbe combined with other urine chemistry resultsreceived from an LIS. It produces quantitative orqualitative counts of all formed sedimentelements present in urine, including cells, casts,crystals, and organisms. A competent humanoperator can set criteria for auto-reporting andflagging specimens for review. All instrumentanalyte image decisions may be reviewed andoverridden by a trained technologist.The iQ200 Urine Analyzer Body Fluids Moduleis an in-vitro diagnostic device used by anappropriately trained laboratory user to examineand count red blood cells and nucleated cells incerebrospinal fluid, serous fluids and synovialfluid.	No change
Performance andCharacterization	IQ200 System - K022774 (Cleared Oct. 21,2002), K050235 (Cleared Mar. 23, 2005),K093861 (Cleared Feb. 05, 2010), K091539(Cleared Aug. 31, 2010)	Proposed Device
Specimen analyzed	iQ200 System:Urine collected in a cup or other container andtransferred to a tube for analysis.iQ Body Fluids and Synovial:Hyaluronidase is added to the specimen, mixedand incubated. Two aliquots from each bodyfluid specimen are prepared. One aliquot isdiluted in normal saline to provide aconcentration in the linear range of theinstrument. The second aliquot is treated with alysing reagent to allow unambiguousidentification of WBC and other nucleated cellsby eliminating RBC confusion. Particle imagesare captured and saved electronically as thesample flows past a microscope objective at ahigh speed, electronically concentratingparticles. Particle images are then ordered bysize into assigned categories on a video display.	No change
Mechanism forintroducingspecimen	Specimen automatically mixed and withdrawnfrom a tube into the analytical system.	No change
Mechanism forpresentingindividual formedelement images tomicroscopeobjective	Individual elements in liquid suspensionautomatically selected and imaged by amicroscope objective as they move through aflow cell.	No change
Presentation ofimages for viewing	Individual formed elements are presented on avideo monitor on a separate microcomputer inmachine-ordered and counted groups by analytetype or by like size.	No change
Performance andCharacterization	IQ200 System - K022774 (Cleared Oct. 21,2002), K050235 (Cleared Mar. 23, 2005),K093861 (Cleared Feb. 05, 2010), K091539(Cleared Aug. 31, 2010)	Proposed Device
Features used todistinguish amongformed elementtypes	Differential staining separates cells andorganisms.Casts are discerned based on size and density.Crystals are determined based on size, shape,and refractive intensity.	No change
Microscopicsediment andchemistry resultsare saved incomputer memoryprior to review,and release byoperator.	Result data are stored on the workstation forlater review, independent of analysis.	No change
Presentation ofimages to skilled,competent observer	Formed elements in the flow cells are viewedthrough a microscope by a video camera.Images are captured and electronically presentedto a skilled, competent observer forinterpretation on a video monitor.	No change
Image montageorganization andcomprehension	Formed elements are sorted into groups ofanalytes determined by machine classification.All groups are displayed in a single montage for"at a glance" visual confirmation. Individualgroups can also be viewed independently.	No change
Reclassification offormed elementimages by acompetent observer	Formed element images displayed can bereclassified by selecting a "button" for thecorrect analyte type and then selecting individualimages to be renamed.	No change
Performance andCharacterization	IQ200 System – K022774 (Cleared Oct. 21, 2002), K050235 (Cleared Mar. 23, 2005),K093861 (Cleared Feb. 05, 2010), K091539 (Cleared Aug. 31, 2010)	Proposed Device
Results areobserved andexpressed	Scanning is accomplished “at a glance” of amontage on a video monitor displaying allformed element images detected. Final countsare based on machine classification of analyteimages or those of a competent observer if thespecimen is flagged for human review or theoperator chooses to provide analyteidentifications.	No change
Throughput	• 101 urine sample/hour• 70 urine sample/hour• 40 urine sample/hour	No Change
Software	APUI Software version 6.2	APUI Software version7.2 (for Windows7 & XPOS)

Table 1 - iQ200 System

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Table 2 - iChemVELOCITY Automated Urine Chemistry

	iChemVELOCITY AnalyzerK101852 (cleared on 3/23/2011) andK171083 (cleared on 05/12/2017)	Proposed Device
Intended Use	The iChemVELOCITY automated urinechemistry system is an in vitro diagnosticdevice used to automate the urine chemistryanalysis profile using iChemVELOCITY UrineChemistry Strips. The iChemVELOCITY canbe used as a stand-alone system, as well as in aniQ®200 Series system, a configuration giventhe proprietary name iRICELL as it is designedto be hardware and software compatible withiQ200 Series systems. It produces quantitativeresults for specific gravity; semi-quantitativeresults for glucose, blood, leukocyte esterase,bilirubin, urobilinogen, pH, protein, ketones andascorbic acid; and qualitative results for nitrites,color and clarity. iChemVELOCITY strips areintended for use only with theiChemVELOCITY analyzer. In particular, theyare not intended for visual reading. TheiChemVELOCITY is not intended to be used asa Point of Care (POC) analyzer.These measurements are used to aid in thediagnosis of metabolic disorders, kidneyfunction anomalies, urinary tract infections,	No change
	and liver function. Tests performed using theiChemVELOCITY are intended for clinicallaboratory and in vitro diagnostic use only.
Specimenanalyzed	Urine collected in cup or other container andtransferred to a tube for sampling ontoiChemVELOCITY test strips.	No change
Method ofOperation	Color change on the pads of theiChemVELOCITY strips are analyzed for percentreflectance and converted to results through analgorithm	No change
	Urine color and clarity are obtained by measuringabsorbance or scattering of white light through aflowcell. Intensities of RGB wavelengths aremeasured with a solid-state photodetector array.
	Specific gravity is measured by determining therefractive index of the specimen
Energy Source	AC power is converted to DC by an internalswitching mode power supply	No change
	iChemVELOCITY AnalyzerK101852 (cleared on 3/23/2011) andK171083 (cleared on 05/12/2017)	Proposed Device
Color Sensor	Taos TCS230	No change
Scatter LED	Luxeonstar/Lumileds SR-01-WC100	No change
Microcontroller	PIC 18F25	No change
Boardcommunications	Universal Asynchronous Receiver/Transmitter(UART)	No change
Firmware	The CCM measures the light intensity in RGBchannels. Then it corrects each channel usingiChemVELOCITY wash solution as a referencesource. The compensated RGB data is convertedto project in 2 dimensional HSL color plane.Method for the HSL color space is boundaries forcolor bins modified and an Ohta Color plane wasadded to refine color measurements along theboundaries of the HSL calculations.	No change
Result format	Semi-quantitative results are presented for colorand clarity. Specifically:Color - Red, Blue, Amber, Yellow, Straw, andColorlessClarity - Turbid, Cloudy, Slightly Cloudy, andClear	No change
Throughput	210 urine sample/hour	No change
Software	APUI Software version 6.2	APUI Software version7.2 (for Windows7 & XPOS)

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Summary of Performance Testing:

To demonstrate substantial equivalence (SE), the following design performance verification analysis was performed and evaluated:

Method Comparison

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Design Control Activities

The development and design verification and validation of the device software modification has been performed under design controls. The design control activities were based on risk analysis, and acceptance criteria were set to maintain the efficiency and safety of the device. Design testing included: software verification, system performance verification, human factors, and installation.

Substantial Equivalence Conclusion to Demonstrate Safety, Effectiveness & Equivalent Performance to Predicate:

The updates to the iQ200 System and iChemVELOCITY analyzers that are the subject of this submission, do not change the intended use, nor add or delete a contraindication for the device. The changes do not alter the device control mechanism, operating principle, energy type, environmental specification, ergonomics of the user interface, dimensional specifications, nor packaging.

The device does not have expiration dating nor is it subject to sterilization.

In summary, it can be concluded that the updated iQ200 System and iChemVELOCITY analyzers, as described in this submission is substantially equivalent in terms of safety and effectiveness to the predicate device.

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.

Regulation Number and Section

§ 864.5200 Automated cell counter.

(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).