VITROS® Automation Solutions is intended to automate pre-analytical sample processing in the clinical laboratory. VITROS® Automation Solutions allows the consolidation of software, automation modules and clinical analyzers, such as VITROS® Systems into a unified workstation to perform a variety of assays such as total T4, carbamazepine and gentamicin.

Carbamazepine measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose. Gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. Total thyroxine (T4) measurements are used to aid in the differential diagnosis of thyroid disease.

Device Description

VITROS® Automation Solutions is a configurable, scalable laboratory automation system (LAS) designed to streamline pre and post analytical processes in the clinical laboratory. VITROS® Automation Solutions is comprised of personal computer (PC) Kit(s) (including software and hardware), sample conveyors with turns, parallel and perpendicular bypasses, storage module, single-tube entry, rack entry and exit, centrifuge, de-capper modules and clinical analyzers.

In the basic configuration, patient sample tubes are loaded onto the automation track to be centrifuged, de-capped, and sorted for further processing on clinical analyzers such as the VITROS® Systems. Additional modules may be added to enable aliquot capability, sample capping, and refrigerated storage.

Parallel and perpendicular bypasses are extensions of the automation track that link with an analyzer's existing laboratory automation system (LAS) interface. These bypasses support on-track metering at the analyzer based on point-in-space pipetting technology and robotic interface module (RIM). With point in space pipetting, the automation performs the sample bar code read function, presents the sample identification to the connected analyzer, and then signals for direct sampling of the open tube by the connected analyzer at an aspiration point on the automation track. With robotic interface modules, the sample tube is transferred to the analyzer and the analyzer will read the bar code to identify the sample, aspirate sample from the tube and perform the test(s) requested and then return the tube to the LAS.

VITROS® Automation Solutions allows the establishment of a connection with clinical analyzers such as VITROS® Systems to enable sample routing based on reagent and calibration status. The clinical analyzers, such as VITROS® Systems, will perform all functions with respect to result generation, including sample metering, assay processing and reporting for the assays.

The VITROS® Systems are fully automated, computer controlled, clinical chemistry and immunodiagnostic analyzers intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, drugs of abuse, proteins, infectious diseases, as well as cardiac, metabolic, thyroid, anemia, and oncology markers in biological fluids such as serum, plasma, urine and cerebral spinal fluid.

The VITROS® Systems operate in conjunction with VITROS® Immunodiagnostic and Chemistry Products, reagents, calibrators and controls designed for use with the systems in the MicroSlide, MicroTip or MicroWell format. Representative assays (carbamazepine, gentamicin and total thyroxine) are used to demonstrate acceptable performance.

AI/ML Overview

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided document is a 510(k) summary for a laboratory automation system. It focuses on demonstrating "substantial equivalence" to a predicate device, rather than providing detailed acceptance criteria in the same way a clinical trial for a diagnostic algorithm might. Therefore, some of the requested information (like effect size for MRMC studies, details of expert qualifications, or sample size for training sets) is not directly present as it's not typically required for this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the VITROS® Automation Solutions as a standalone device with specific performance metrics (e.g., sensitivity, specificity). Instead, it aims to demonstrate substantial equivalence by showing that assay performance characteristics remain consistent whether samples are introduced manually or via the automation system. The acceptance criterion is implied to be that the automated method should produce results comparable to the manual method.

Acceptance Criterion (Implied)	Reported Device Performance
Linear regression analysis demonstrating comparable performance for each assay across the range of sample concentrations tested, with no clinically significant difference between automated and manual sample processing.	CRBM (µg/mL): Slope = 1.04, Intercept = -0.0905, R² = 0.9796 (N=70, Sample Range 3.09 – 17.12)
GENT (µg/mL): Slope = 1.00, Intercept = 0.0075, R² = 0.9989 (N=55, Sample Range 0.63 – 9.72)
Total T4 (nmol/L): Slope = 1.01, Intercept = -1.1936, R² = 0.9969 (N=57, Sample Range 12.70 – 288.70)

Conclusion from document: "The test results showed no clinically significant difference in assay performance between the two sample processing methods. This data demonstrates substantial equivalence between VITROS® Automation Solutions and the stand-alone analyzer, VITROS® Systems."

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

Sample Size for Test Set:
- CRBM: 70 samples
- GENT: 55 samples
- Total T4: 57 samples
Data Provenance: The study used "patient samples." The country of origin is not specified, but the applicant (Ortho-Clinical Diagnostics, Inc.) is based in Rochester, New York, USA. The study design is retrospective in the sense that existing patient samples were used for comparative testing. It is not explicitly stated if these were left-over clinical samples or prospectively collected for the study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of information (number and qualifications of experts) is not relevant or provided for this submission. The "ground truth" here is the result obtained from manual processing on the VITROS® System itself, which is a standardized and validated analytical method, not expert interpretation.

4. Adjudication Method

Not applicable. This study compares analytical results from an automated process versus a manual process using the same analyzer. There's no human interpretation or adjudication involved in establishing the "correct" value, as it's a quantitative measurement compared against another quantitative measurement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC study was not done. This device is a laboratory automation system, not an AI or imaging diagnostic tool that involves human readers. The study focuses on the analytical performance of the automated sample processing system compared to manual processing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes, in a sense, the performance shown for the automated system is "standalone" to the degree that it measures the impact of the automation on the analyzer's performance, independent of human intervention beyond loading samples onto the system. The automation itself does not produce a "reading" that a human would then confirm or interpret; rather, it handles the pre-analytical processing to feed into existing, validated analyzers. The data presented demonstrates the performance of tests conducted via the automation solution, which then provides results without further human modification.

7. Type of Ground Truth Used

The ground truth was established by:

Comparison to manual processing results: The "ground truth" or reference method was the results obtained from samples manually introduced to the standalone VITROS® System (referred to as "off track" in the document). This is a validated and established method on a legally marketed device.

8. Sample Size for the Training Set

This information is not applicable and not provided. This submission is for a laboratory automation system, not a machine learning model that requires a training set. The system's functionality is based on mechanical and software-driven processes, not adaptive learning.

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

Not applicable, as there is no training set for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 18, 2016

ORTHO-CLINICAL DIAGNOSTICS, INC. DARLENE PHILLIPS MANAGER REGULATORY AFFAIRS 100 INDIGO CREEK DRIVE MC00881 ROCHESTER NY 14626

Re: K160495

Trade/Device Name: VITROS® Automation Solutions Regulation Number: 21 CFR 862.1700 Regulation Name: Total thyroxine test system Regulatory Class: II Product Code: KLI, JJE, KLT, LCD Dated: August 19, 2016 Received: August 22, 2016

Dear Darlene Phillips:

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.

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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.

Katherine Serrano -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

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Indications for Use

510(k) Number (if known) K160495

Device Name VITROS® Automation Solutions

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter Information

Name	Ortho-Clinical Diagnostics, Inc.
Address	100 Indigo Creek DriveRochester, New York 14626
Phone number	(585) 453-4253
Fax number	(585) 453-3368
EstablishmentRegistrationNumber	1319681
Name of contactperson	Darlene J Phillips
Date prepared	October 6, 2016
Name of devices
Trade or proprietarynames	VITROS® Automation Solutions
Common or usualname	Laboratory Automation System
Classification Name	Regulation	Product	Device

Classification Name	Regulationnumber	Productcode	Deviceclass	Review panel
Carbamazepine testsystem	862.3645	KLT	II	Toxicology
Gentamicin test system	862.3450	LCD	II	Toxicology
Total thyroxine testsystem	862.1700	KLI	II	Clinical Chemistry
Discrete photometricchemistry analyzers forclinical use	862.2160	JJE	I	Clinical Chemistry

Legally marketed device(s) to which equivalence is claimed

Ortho claims that VITROS® Automation Solutions is substantially equivalent to the enGen™ Laboratory Automation System with VITROS® 5,1 FS Chemistry System K063144

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Device description

Intended Use/ Indications for Use

VITROS® Automation Solutions is intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory. VITROS® Automation Solutions allows the consolidation of software, automation modules and clinical analyzers, such as VITROS® Systems into a unified workstation to perform a variety of assays such as total T4, carbamazepine and gentamicin.

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Carbamazepine measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose. Gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. Total T4 measurements are used to aid in the differential diagnosis of thyroid disease.

Similarities Table
Attribute	Predicate device	New device
	enGen™ Laboratory Automation Systemwith VITROS® 5,1 FS Chemistry SystemK063144	VITROS® AutomationSolutions (sample anddata processing modules,software and clinicalanalyzers, such asVITROS® Systems)
Intended Use	A clinical laboratory automation system that is intended toperform automated pre-analytical and post-analytical sampleand data management. The System automates samplehandling and data management through the use ofmiddleware, automation, driver software and a configurationfile. The System is interfaced mechanically andelectronically to analyzers and a Laboratory InformationSystem (LIS).	Same
System Design	Each installation of the System requires a baselineconfiguration file determined by the unique combination ofmodules and clinical analyzers and the supported test menuthat will be integrated with each installation of the System.	Same
Sample TransferMethod	Supports both "Point-in-space" and the physical transfer ofthe sample tube/rack from the automation track to theanalyzer's sample load and identification area usingautomation interface modules.	Same
FundamentalTechnology	Outboard analyzer connections accessed by track bypassmodules and/or robotic interface	Same
Attribute	Predicate device	New device
	enGen™ Laboratory Automation Systemwith VITROS® 5,1 FS Chemistry SystemK063144	VITROS® AutomationSolutions (sample anddata processing modules,software and clinicalanalyzers, such asVITROS® Systems)
System Modules	Instrument Manager Hardware/software	Same
	TCAutomation Software	Same
	TCAutomation Modules including but not limited to:	Same
	Rack Entry/Exit Modules, Single Tube Entry Modules Conveyors and turns Centrifuges (operating as a single cluster) Decappers Aliquoter Recappers Bypasses for analyzers such as VITROS® Systems and 3rd party analyzers ES Flex Module	Same
ChemistryAnalyzerConnection	Clinical analyzers such as,	Same
	VITROS® 5,1 FS Chemistry System	Same
	VITROS® 4600 Chemistry System	Same
	VITROS® 3600 Immunodiagnostics Systems	Same
	VITROS® 5600 Integrated Systems	Same
VITROS®Products AssaysPerformed	VITROS® Chemistry and Immunodiagnostic ProductsAssays such as	Same
	VITROS® CRBM Slides assay	Same
	VITROS® GENT Reagent assay	Same
	VITROS® Total T4 Reagent assay	Same
SampleIdentification	Sample bar code read by automation linked to Transportcarriers identified on the system by Radio-frequencyidentification (RFID) tags, presented to instrument via BypassModule	Same
Sample Handling	The ability to interface with a LIS device to receive patientidentification and test requests via a communications protocolto provide sample tracking via bar code labeling and RFID.	Same
	Processes multiple tube sizes/types simultaneously; sorts andmaps samples for routing, storage, and retrieval; performsintelligent sample routing based on system status	Same

Comparison with Predicate Devices:

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Attribute	Predicate deviceenGen™ Laboratory Automation Systemwith VITROS® 5,1 FS Chemistry SystemK063144	New deviceVITROS® AutomationSolutions (sample anddata processing modules,software and clinicalanalyzers, such asVITROS® Systems)
SoftwareComponents	Data Innovations• Instrument Manager™ Core with driversThermo Fisher Scientific• TCAutomation software communicates to IM andtrack	SameSame
Difference Table
Attribute	Predicate deviceenGen™ Laboratory AutomationSystem with VITROS® 5,1 FSChemistry SystemK063144	New deviceVITROS® Automation Solutions(sample and data processing modules,software and clinical analyzers, such asVITROS® Systems)
SoftwareComponents	Developed and provided by OrthoenGen configuration file (gsb)• sample routing and reprocessing• includes Autoverification	Developed and provided by Data Innovations• Incorporated into Automation Driver,Instrument Driver, Universal LISDriver and Out of Service driver• Optional VITROS AutoverificationRules set – developed by DataInnovations

Performance Summary:

Non-Clinical Testing Analytical Performance:

Assay performance characteristics were established in VITROS® CRBM assay K980283, VITROS® GENT assay K042479 and VITROS® Total T4 assay K964721. These performance characteristics are dependent on the assay and the VITROS® Systems which have not changed.

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Method Comparison

To establish equivalence between results for samples manually introduced to the analyzer versus automated sample introduction and identification to the analyzer, a method comparison has been performed using the VITROS® CRBM, GENT and Total T4 assays.

The comparison study was performed using patient samples processed through the appropriate laboratory protocol using a representative configuration of VITROS® Automation Solutions (on-track) followed by manual load directly to the VITROS® System (off track).

The linear regression analysis demonstrates comparable performance across the range of sample concentrations tested for each representative assay.

Assay	Sample Range	N	Slope	Intercept	R2
CRBM(µg/mL)	3.09 – 17.12	70	1.04	-0.0905	0.9796
GENT(µg/mL)	0.63 – 9.72	55	1.00	0.0075	0.9989
Total T4(nmol/L)	12.70 – 288.70	57	1.01	-1.1936	0.9969

The test results showed no clinically significant difference in assay performance between the two sample processing methods. This data demonstrates substantial equivalence between VITROS® Automation Solutions and the stand-alone analyzer, VITROS® Systems.

Conclusion

The information submitted demonstrates substantial equivalence between VITROS® Automation Solutions and the predicate, enGen™ Laboratory Automation System.

Regulation Number and Section

§ 862.1700 Total thyroxine test system.

(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.