(239 days)
Not Found
No
The description focuses on the automation of physical sample handling and routing, with no mention of AI or ML algorithms for data analysis, interpretation, or decision-making beyond basic routing logic based on analyzer status.
No.
Explanation: The device is intended to automate pre-analytical sample processing in a clinical laboratory and performs analysis for diagnostic purposes. It is not designed to treat or alleviate a disease.
Yes
Explanation: The "VITROS® Automation Solutions" device is described as allowing "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." The assays themselves (e.g., total T4, carbamazepine, gentamicin) are explicitly stated to be "used to aid in the differential diagnosis of thyroid disease," "monitor patient compliance and therapy, and to diagnose potential overdose," and "used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy," respectively. The "VITROS® Systems" which are part of the Automation Solutions are also described as "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." These functions directly support diagnosis or monitoring of disease, which are diagnostic purposes.
No
The device description explicitly states that 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." This indicates it is a system with significant hardware components, not solely software.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the VITROS® Automation Solutions is intended to automate pre-analytical sample processing in the clinical laboratory. It facilitates the handling and routing of samples to clinical analyzers.
- Device Description: The description details the components of the automation system, such as conveyors, storage modules, centrifuges, and de-cappers. These are all involved in sample handling and preparation, not in performing diagnostic tests themselves.
- Role of Clinical Analyzers: The text explicitly states that 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. This indicates that the diagnostic testing is performed by separate devices (the analyzers), not the automation system.
- VITROS® Systems are the IVDs: The description of the VITROS® Systems clearly identifies them as "fully automated, computer controlled, clinical chemistry and immunodiagnostic analyzers intended for the in vitro determination of a variety of general chemistries... in biological fluids". This is the definition of an IVD.
The VITROS® Automation Solutions is a laboratory automation system that supports the workflow of IVD devices (the clinical analyzers), but it does not perform the diagnostic testing itself.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KLI, JJE, KLT, LCD
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.
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
clinical laboratory
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
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).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison
Sample Size: CRBM: 70, GENT: 55, Total T4: 57
Key Results: The linear regression analysis demonstrates comparable performance across the range of sample concentrations tested for each representative assay. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1700 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an emblem depicting three stylized human profiles facing to the right, resembling an eagle or bird in flight. The registered trademark symbol is present in the upper left corner of the logo.
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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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
2
Indications for Use
510(k) Number (if known) K160495
Device Name VITROS® Automation Solutions
Indications for Use (Describe)
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
Submitter Information
| Name | Ortho-Clinical Diagnostics, Inc. | |||
|---|---|---|---|---|
| Address | 100 Indigo Creek Drive | |||
| Rochester, New York 14626 | ||||
| Phone number | (585) 453-4253 | |||
| Fax number | (585) 453-3368 | |||
| Establishment | ||||
| Registration | ||||
| Number | 1319681 | |||
| Name of contact | ||||
| person | Darlene J Phillips | |||
| Date prepared | October 6, 2016 | |||
| Name of devices | ||||
| Trade or proprietary | ||||
| names | VITROS® Automation Solutions | |||
| Common or usual | ||||
| name | Laboratory Automation System | |||
| Classification Name | Regulation | Product | Device |
| Classification Name | Regulation
number | Product
code | Device
class | Review panel |
|-----------------------------------------------------------------|----------------------|-----------------|-----------------|--------------------|
| Carbamazepine test
system | 862.3645 | KLT | II | Toxicology |
| Gentamicin test system | 862.3450 | LCD | II | Toxicology |
| Total thyroxine test
system | 862.1700 | KLI | II | Clinical Chemistry |
| Discrete photometric
chemistry analyzers for
clinical 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
4
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.
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.
5
Г
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 System | ||
| with VITROS® 5,1 FS Chemistry System | ||
| K063144 | VITROS® Automation | |
| Solutions (sample and | ||
| data processing modules, | ||
| software and clinical | ||
| analyzers, such as | ||
| VITROS® Systems) | ||
| Intended Use | A clinical laboratory automation system that is intended to | |
| perform automated pre-analytical and post-analytical sample | ||
| and data management. The System automates sample | ||
| handling and data management through the use of | ||
| middleware, automation, driver software and a configuration | ||
| file. The System is interfaced mechanically and | ||
| electronically to analyzers and a Laboratory Information | ||
| System (LIS). | Same | |
| System Design | Each installation of the System requires a baseline | |
| configuration file determined by the unique combination of | ||
| modules and clinical analyzers and the supported test menu | ||
| that will be integrated with each installation of the System. | Same | |
| Sample Transfer | ||
| Method | Supports both "Point-in-space" and the physical transfer of | |
| the sample tube/rack from the automation track to the | ||
| analyzer's sample load and identification area using | ||
| automation interface modules. | Same | |
| Fundamental | ||
| Technology | Outboard analyzer connections accessed by track bypass | |
| modules and/or robotic interface | Same | |
| Attribute | Predicate device | New device |
| enGen™ Laboratory Automation System | ||
| with VITROS® 5,1 FS Chemistry System | ||
| K063144 | VITROS® Automation | |
| Solutions (sample and | ||
| data processing modules, | ||
| software and clinical | ||
| analyzers, such as | ||
| VITROS® 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 | |
| Chemistry | ||
| Analyzer | ||
| Connection | 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 Assays | ||
| Performed | VITROS® Chemistry and Immunodiagnostic Products | |
| Assays such as | Same | |
| VITROS® CRBM Slides assay | Same | |
| VITROS® GENT Reagent assay | Same | |
| VITROS® Total T4 Reagent assay | Same | |
| Sample | ||
| Identification | Sample bar code read by automation linked to Transport | |
| carriers identified on the system by Radio-frequency | ||
| identification (RFID) tags, presented to instrument via Bypass | ||
| Module | Same | |
| Sample Handling | The ability to interface with a LIS device to receive patient | |
| identification and test requests via a communications protocol | ||
| to provide sample tracking via bar code labeling and RFID. | Same | |
| Processes multiple tube sizes/types simultaneously; sorts and | ||
| maps samples for routing, storage, and retrieval; performs | ||
| intelligent sample routing based on system status | Same |
Comparison with Predicate Devices:
T
6
7
| Attribute | Predicate device
enGen™ Laboratory Automation System
with VITROS® 5,1 FS Chemistry System
K063144 | New device
VITROS® Automation
Solutions (sample and
data processing modules,
software and clinical
analyzers, such as
VITROS® Systems) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software
Components | Data Innovations
• Instrument Manager™ Core with drivers
Thermo Fisher Scientific
• TCAutomation software communicates to IM and
track | Same
Same |
| Difference Table | | |
| Attribute | Predicate device
enGen™ Laboratory Automation
System with VITROS® 5,1 FS
Chemistry System
K063144 | New device
VITROS® Automation Solutions
(sample and data processing modules,
software and clinical analyzers, such as
VITROS® Systems) |
| Software
Components | Developed and provided by Ortho
enGen configuration file (gsb)
• sample routing and reprocessing
• includes Autoverification | Developed and provided by Data Innovations
• Incorporated into Automation Driver,
Instrument Driver, Universal LIS
Driver and Out of Service driver
• Optional VITROS Autoverification
Rules set – developed by Data
Innovations |
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.
8
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.