(56 days)
VITROS Immunodiagnostic Products TSH Reagent Pack
For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or Heparin) using the VITROS ECi/ECIQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
VITROS Immunodiagnostic Products TSH Calibrators
For in vitro use in the calibration of the VITROS ECi/ECIQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or Heparin).
VITROS 3600 Immunodiagnostic System
For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
The VITROS Immunodiagnostic Product TSH Reagent and Calibrators is intended for use on the VITROS 3600 Immunodiagnostic System.
The VITROS 3600 Immunodiagnostic System utilizes the existing VITROS ECi/ECIQ Immunodiagnostic System technology (K962919) and adds increased operating efficiency and throughput by utilizing the same immunoassay hardware and software subsystem design as the VITROS 5600 Integrated System (K081543). All VITROS Immunodiagnostic Product technology, methodologies and analytical methods currently available on the existing two systems (VITROS ECi/ECIQ Immunodiagnostic System and VITROS 5600 Integrated System) are available on the new VITROS 3600 Immunodiagnostic System.
This document describes a Special 510(k) submission for the VITROS Immunodiagnostic Products TSH Reagent Pack, TSH Calibrators, and VITROS 3600 Immunodiagnostic System. The primary purpose of this submission is to notify FDA of the modification to allow the existing TSH Reagent Pack and Calibrators to be used with the new VITROS 3600 Immunodiagnostic System.
The information provided focuses on the substantial equivalence of the modified device to a previously cleared predicate device (K081543) and does not contain detailed primary study data or acceptance criteria typically found in initial device clearance submissions. Therefore, a comprehensive table of acceptance criteria and reported device performance directly from a new study is not available in the provided text. Instead, the document asserts substantial equivalence based on shared technology and performance characteristics with established systems.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific acceptance criteria or report new device performance metrics from a dedicated study for this particular Special 510(k) submission. This is because the submission's core argument is substantial equivalence to a previously cleared device (K081543, for the VITROS TSH assay on the VITROS 5600 Integrated System) and prior cleared technology (K962919, for the VITROS ECi/ECiQ Immunodiagnostic System).
The submission states: "The modified device has the same intended use, fundamental scientific technology and operating principle as the predicate device. The modified VITROS Immunodiagnostic Products TSH assay is substantially equivalent to the product previously cleared with Premarket Notification number K081543."
This implies that the performance of the VITROS TSH assay on the VITROS 3600 system is expected to meet the same performance criteria that were established and accepted for the K081543 submission. Without access to K081543, specific quantitative acceptance criteria cannot be listed here.
2. Sample size used for the test set and the data provenance
The provided text does not include information about a specific test set sample size or data provenance (country of origin, retrospective/prospective) for this Special 510(k) submission. Given that this is a Special 510(k) focused on system modification and substantial equivalence, new clinical performance studies with dedicated test sets are often not required if the changes do not significantly impact safety or effectiveness. The claim is that the VITROS 3600 uses the existing VITROS ECi/ECiQ technology and the same immunoassay hardware and software subsystem design as the VITROS 5600.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
This information is not provided in the document. As this is a laboratory diagnostic device, ground truth for TSH measurements would typically be based on established reference methods, external quality assurance programs, or certified reference materials, rather than expert consensus on individual cases.
4. Adjudication method for the test set
This information is not provided in the document. It is unlikely to be relevant for a submission of this nature, focused on an in vitro diagnostic device measuring a specific analyte.
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
Not applicable. This device is an in vitro diagnostic immunodiagnostic system for measuring Thyroid Stimulating Hormone (TSH). It is not an AI-assisted diagnostic imaging device or a device involving human "readers" in the context of interpretation that would necessitate an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable in the context of "algorithm only." The device is an automated in vitro diagnostic instrument. Its performance is evaluated as a standalone system (instrument, reagent, calibrators) in measuring TSH concentration. The "algorithm" here would refer to the instrument's internal measurement and calculation processes, and its "standalone performance" is what the overall system performance studies (implicitly referenced by substantial equivalence to K081543) would evaluate. The results are quantitative measurements, not interpretations requiring human review in the same way an imaging algorithm might.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the ground truth type used for the original validation of the TSH assay (K081543). However, for quantitative in vitro diagnostic assays like TSH, ground truth is typically established through:
- Reference Intervals: Established by analyzing samples from a healthy population using a highly accurate and precise reference method.
- Assigned Values of Certified Reference Materials: Using internationally recognized standards and calibrators.
- Correlation with Established Methods: Comparing results to a legally marketed predicate device or gold standard method for TSH measurement.
8. The sample size for the training set
This information is not provided as the submission is not focused on developing a new algorithm but adapting an existing assay to a new instrument platform. The concept of a "training set" is generally more relevant for machine learning algorithms or new assay development, neither of which is the primary focus of this Special 510(k). All "technology, methodologies and analytical methods" are stated to be "currently available on the existing two systems."
9. How the ground truth for the training set was established
This information is not provided and is likely not applicable for the reasons stated in point 8.
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DEC 22 2003
б 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
:
The assigned 510(k) number is: _ | 083173_
| Submitter: | Ortho-Clinical Diagnostics, Inc.100 Indigo Creek Drive MC00881Rochester, New York 14626-5101 |
|---|---|
| Contact Person: | Leah Van De WaterPhone: (585) 453-4131FAX: (585) 453-4402Email: Ivandewa@ocdus.jnj.com |
| Preparation date: | October 24, 2008 |
| Registration Number: | The establishment number for the VITROS ImmunodiagnosticProducts TSH Reagent Pack and Calibrators is 9680658.The establishment number for the VITROS 3600Immunodiagnostic System is 1319681. |
| Purpose for Submission: | Ortho-Clinical Diagnostics hereby submits this Special 510(k) toprovide notification of modification to the VITROSImmunodiagnostic Products TSH Reagent Pack and VITROSImmunodiagnostic Products TSH Calibrators. The reagent packand calibrators were previously cleared for use with the VITROSECi/ECiQ Immunodiagnostic System and VITROS 5600Integrated System (K081543). The modifications include theuse of the VITROS TSH Reagent Pack and Calibrators with theVITROS 3600 Immunodiagnostic System.The VITROS 3600 Immunodiagnostic System is a new memberof the VITROS family of analyzers and uses VITROSImmunodiagnostic reagents, calibrators and controls identical tothe VITROS ECi/ECiQ Immunodiagnostic System and VITROS5600 Integrated System. The VITROS 3600 ImmunodiagnosticSystem uses the existing VITROS ECi/ECiQ ImmunodiagnosticSystem technology and adds increased operating efficiency andthroughput by utilizing the same immunoassay hardware andsoftware subsystem design as the VITROS 5600 IntegratedSystem. The VITROS ECi/ECiQ Immunodiagnostic Systemwas cleared as part of Premarket Notification number K962919.The VITROS 5600 Integrated System was cleared as part ofPremarket Notification number K081543. |
| SPECIAL 510(K) SUBMISSION | Ortho-Clinical Diagnostics, Inc. |
SPECIAL 510(K) SUBMISSION
VITROS TSH and 3600
.
Page 41 of 74
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| Trade or ProprietaryName: | VITROS® Immunodiagnostic Products TSH Reagent PackVITROS® Immunodiagnostic Products TSH CalibratorsVITROS® 3600 Immunodiagnostic System |
|---|---|
| Common Name: | VITROS TSH Test System |
| Classification Name: | Thyroid Stimulating Hormone Test System (21 CFR 862.1690);Calibrators (21 CFR 862.1150); Fluorometer for clinical use (21CFR 862.2560) |
| Device Intended Use: | VITROS Immunodiagnostic Products TSH Reagent PackFor the in vitro quantitative measurement of thyroid stimulatinghormone (TSH) in human serum and plasma (EDTA or Heparin) usingthe VITROS ECi/ECIQ Immunodiagnostic Systems, VITROS 3600Immunodiagnostic System and VITROS 5600 Integrated System to aidin the differential diagnosis of thyroid disease.VITROS Immunodiagnostic Products TSH CalibratorsFor in vitro use in the calibration of the VITROS ECi/ECIQImmunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systemand VITROS 5600 Integrated System for the quantitative measurementof thyroid stimulating hormone (TSH) in human serum and plasma(EDTA or Heparin).VITROS 3600 Immunodiagnostic SystemFor use in the in vitro quantitative, semi-quantitative, and qualitativemeasurement of a variety of analytes of clinical interest, usingVITROS Immunodiagnostic Products Reagents. |
| Device description: | The VITROS Immunodiagnostic Product TSH Reagent andCalibrators is intended for use on the VITROS 3600Immunodiagnostic System.The VITROS 3600 Immunodiagnostic System utilizes theexisting VITROS ECi/ECIQ Immunodiagnostic Systemtechnology (K962919) and adds increased operating efficiencyand throughput by utilizing the same immunoassay hardware andsoftware subsystem design as the VITROS 5600 IntegratedSystem (K081543). All VITROS Immunodiagnostic Producttechnology, methodologies and analytical methods currentlyavailable on the existing two systems (VITROS ECi/ECIQImmunodiagnostic System and VITROS 5600 IntegratedSystem) are available on the new VITROS 3600Immunodiagnostic System. |
| Substantial Equivalence: | The modified device has the same intended use, fundamentalscientific technology and operating principle as the predicatedevice. The modified VITROS Immunodiagnostic Products |
| SPECIAL 510(K) SUBMISSIONVITROS TSH and 3600 | Ortho-Clinical Diagnostics, Inc.Page 42 of 74 |
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TSH assay is substantially equivalent to the product previously cleared with Premarket Notification number K081543.
SPECIAL 510(K) SUBMISSION VITROS TSH and 3600
Ortho-Clinical Diagnostics, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Leah Van De Water, M.S., RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive MC881 Rochester, NY 14626-5101
DEC 2 2 2008
Re: K083173
Trade/Device Name: VITROS Immunodiagnostic Products TSH Reagent Pack VITROS Immunodiagnostic Products TSH Calibrators VITROS 3600 Immunodiagnostic System Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid Stimulating Hormone test system Regulatory Class: Class II Product Code: JLW, JJE, JIT Dated: December 15, 2008 Received: December 16, 2008
Dear Ms. Van De Water:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR). Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Yéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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2 Indications for Use
| 510(k) Number (if known): | K083173 |
|---|---|
| Device Name: | VITROS Immunodiagnostic Products TSH Reagent PackVITROS Immunodiagnostic Products TSH CalibratorsVITROS 3600 Immunodiagnostic System |
| Indications for Use: | VITROS Immunodiagnostic Products TSH Reagent PackFor the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or Heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.VITROS Immunodiagnostic Products TSH CalibratorsFor in vitro use in the calibration of the VITROS ECI/ECİQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or Heparin).VITROS 3600 Immunodiagnostic SystemFor use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. |
| Prescription Use(Part 21 CFR 801 Subpart D) | X AND/OR Over-The-Counter Use(21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS I INE-CONTINUE ON ANOTHER PAGE IF
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
| Carol Benson |
|---|
| Sign-off |
Page 1 of 1City of In Vitro Diagnostic Device Con and Safety
K08 3173
SPECIAL 510(K) SUBMISSION VITROS TSH and 3600
Page 35 of 74
Ortho-Clinical Diagnostics, Inc.
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.