(239 days)
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.
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.
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.
§ 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.