(56 days)
No
The document describes a standard immunoassay system and reagents, with no mention of AI or ML in the intended use, device description, or any other section.
No
The device is an in vitro diagnostic (IVD) system used to measure TSH levels to aid in the differential diagnosis of thyroid disease, not to treat it.
Yes
The product's intended use explicitly states "to aid in the differential diagnosis of thyroid disease," which indicates it is used for diagnostic purposes.
No
The device description clearly states it is a system that utilizes immunoassay hardware and software, indicating it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the VITROS Immunodiagnostic Products TSH Reagent Pack is "For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma..." and the VITROS Immunodiagnostic Products TSH Calibrators are "For in vitro use in the calibration...". The VITROS 3600 Immunodiagnostic System is also described as being "For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest...". The term "in vitro" is a key indicator of an IVD.
- Purpose: The purpose of these products is to measure analytes (TSH) in biological samples (serum and plasma) to aid in the diagnosis of disease (thyroid disease). This is the core function of an IVD.
- Device Description: The description confirms that the system and reagents are used together for these in vitro measurements.
Therefore, based on the provided information, this device clearly falls under the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JLW, JJE, JIT
Device Description
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.
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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
§ 862.1690 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.
0
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 MC00881
Rochester, New York 14626-5101 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Leah Van De Water
Phone: (585) 453-4131
FAX: (585) 453-4402
Email: Ivandewa@ocdus.jnj.com |
| Preparation date: | October 24, 2008 |
| Registration Number: | The establishment number for the VITROS Immunodiagnostic
Products TSH Reagent Pack and Calibrators is 9680658.
The establishment number for the VITROS 3600
Immunodiagnostic System is 1319681. |
| Purpose for Submission: | Ortho-Clinical Diagnostics hereby submits this Special 510(k) to
provide notification of modification to the VITROS
Immunodiagnostic Products TSH Reagent Pack and VITROS
Immunodiagnostic Products TSH Calibrators. The reagent pack
and calibrators were previously cleared for use with the VITROS
ECi/ECiQ Immunodiagnostic System and VITROS 5600
Integrated System (K081543). The modifications include the
use of the VITROS TSH Reagent Pack and Calibrators with the
VITROS 3600 Immunodiagnostic System.
The VITROS 3600 Immunodiagnostic System is a new member
of the VITROS family of analyzers and uses VITROS
Immunodiagnostic reagents, calibrators and controls identical to
the VITROS ECi/ECiQ Immunodiagnostic System and VITROS
5600 Integrated System. The VITROS 3600 Immunodiagnostic
System uses the existing VITROS ECi/ECiQ Immunodiagnostic
System technology and adds increased operating efficiency and
throughput by utilizing the same immunoassay hardware and
software subsystem design as the VITROS 5600 Integrated
System. The VITROS ECi/ECiQ Immunodiagnostic System
was cleared as part of Premarket Notification number K962919.
The VITROS 5600 Integrated System was cleared as part of
Premarket Notification number K081543. |
| SPECIAL 510(K) SUBMISSION | Ortho-Clinical Diagnostics, Inc. |
SPECIAL 510(K) SUBMISSION
VITROS TSH and 3600
.
Page 41 of 74
1
| Trade or Proprietary
Name: | VITROS® Immunodiagnostic Products TSH Reagent Pack
VITROS® Immunodiagnostic Products TSH Calibrators
VITROS® 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 (21
CFR 862.2560) |
| Device Intended Use: | 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. |
| Device description: | 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. |
| Substantial Equivalence: | The modified device has the same intended use, fundamental
scientific technology and operating principle as the predicate
device. The modified VITROS Immunodiagnostic Products |
| SPECIAL 510(K) SUBMISSION
VITROS TSH and 3600 | Ortho-Clinical Diagnostics, Inc.
Page 42 of 74 |
2
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.
3
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).
4
Page 2 -
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
5
2 Indications for Use
| 510(k) Number (if known): | K083173 |
|---|---|
| Device Name: | VITROS Immunodiagnostic Products TSH Reagent Pack |
| VITROS Immunodiagnostic Products TSH Calibrators | |
| VITROS 3600 Immunodiagnostic System | |
| Indications for Use: | 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/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 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. |
| 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.