K Number
K081543
Device Name
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
Date Cleared
2008-10-23

(143 days)

Product Code
Regulation Number
862.1690
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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 and VITROS 5600 Integrated System for the quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or Heparin). VITROS Chemistry Products PHYT Slides: For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System. VITROS Chemistry Products Calibrator Kit 9: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950 and 5.1 FS Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, PHBR, and PHYT. VITROS 5600 Integrated System: For use in the in vitro quantitative, semi-quantitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Device Description
The VITROS Immunodiagnostic Products TSH assay and VITROS Chemistry Products PHYT assay are intended for use on the VITROS 5600 Integrated System. The VITROS 5600 Integrated System combines the existing VITROS 5,1 FS Chemistry System (K031924) and the VITROS ECi/ECiQ Immunodiagnostic System (K962919) into a single system. All technology, methodologies and analytical methods currently available on the existing two systems are available on the new integrated system.
More Information

No
The summary describes a standard in vitro diagnostic system and assays, with no mention of AI or ML technologies in the intended use, device description, or any other section. The system combines existing, predicate devices without introducing new analytical methods that would typically involve AI/ML.

No.
The device is an in vitro diagnostic (IVD) system used for quantitative measurements of analytes in human samples to aid in diagnosis, not for direct therapeutic treatment.

Yes

The "Intended Use / Indications for Use" section explicitly states that the VITROS Immunodiagnostic Products TSH Reagent Pack is "to aid in the differential diagnosis of thyroid disease" and the VITROS Chemistry Products PHYT Slides are "For in vitro diagnostic use only." The VITROS 5600 Integrated System also specifies its use for "in vitro quantitative, semi-quantitative measurement of a variety of analytes of clinical interest," which are typically used for diagnostic purposes.

No

The device description clearly states it is an "Integrated System" combining existing hardware systems (VITROS 5,1 FS Chemistry System and VITROS ECi/ECiQ Immunodiagnostic System). It is a physical laboratory instrument, not a software-only device.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Explicit Statements: The "Intended Use / Indications for Use" section for multiple components explicitly states "For in vitro diagnostic use only" or "For the in vitro quantitative measurement...".
  • Device Description: The description of the VITROS 5600 Integrated System states it is "For use in the in vitro quantitative, semi-quantitative measurement of a variety of analytes of clinical interest".
  • Nature of the Tests: The tests performed (TSH, Phenytoin) are measurements of substances in bodily fluids (serum and plasma) to aid in the diagnosis of disease (thyroid disease). This is a core function of IVDs.

The document clearly indicates that the system and its components are designed to be used outside of the body to examine specimens for diagnostic purposes.

N/A

Intended Use / Indications for Use

The following indications for use are provided:

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 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 and VITROS 5600 Integrated System for the quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or Heparin).

VITROS Chemistry Products PHYT Slides
For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System.

VITROS Chemistry Products Calibrator Kit 9
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950 and 5.1 FS Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, PHBR, and PHYT.

VITROS 5600 Integrated System
For use in the in vitro quantitative, semi-quantitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

Product codes (comma separated list FDA assigned to the subject device)

JLW, DIP, JJE, JIT

Device Description

The VITROS Immunodiagnostic Products TSH assay and VITROS Chemistry Products PHYT assay are intended for use on the VITROS 5600 Integrated System.

The VITROS 5600 Integrated System combines the existing VITROS 5,1 FS Chemistry System (K031924) and the VITROS ECi/ECiQ Immunodiagnostic System (K962919) into a single system. All technology, methodologies and analytical methods currently available on the existing two systems are available on the new integrated 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.

K964558, K941142

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.

K031924, K962919

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

510(k) Summary

OCT 2 3 2008

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.

81543 The assigned 510(k) number is: Ortho-Clinical Diagnostics, Inc. Submitter: 100 Indigo Creek Drive MC00881 Rochester, New York 14626-5101 Leah Van De Water Contact Person: Phone: (585) 453-4131 FAX: (585) 453-4402 Email: Ivandewa@ocdus.jnj.com September 22, 2008 Preparation date: Registration Number: The establishment number for the VITROS Immunodiagnostic Products TSH Reagent Pack and Calibrators is 9680658. The establishment number for the VITROS Chemistry Products PHYT Slides is 1319809. The establishment number for the VITROS Chemistry Products Calibrator Kit 9 is 1319808. The establishment number for the VITROS 5600 Integrated 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 assay and VITROS Chemistry Products PHYT assay. The TSH assay is cleared for use with the VITROS ECi/ECiQ Immunodiagnostic System. The PHYT assay is cleared for use with the VITROS 5,1 FS Chemistry System. The modifications include the use of the VITROS TSH and PHYT assays with the VITROS 5600 Integrated System. The VITROS 5600 Integrated System is a new member of the VITROS family of analyzers and uses reagents, calibrators and controls identical to the VITROS ECi/ECiQ Immunodiagnostic System and VITROS 5,1 FS Chemistry System. The VITROS 5600 Integrated System is an integration of the VITROS 5,1 FS Chemistry System, which performs MicroSlide and MicroTip assays and the VITROS ECi/ECiO Immunodiagnostic System, which performs MicroWell assays. The VITROS 5,1 FS Chemistry System was cleared as part of Premarket Notification number K031924. The VITROS ECi/ECiO Immunodiagnostic System was cleared as part of Premarket Notification number K962919.

1

| Trade or Proprietary
Name: | VITROS® Immunodiagnostic Products TSH Reagent Pack
VITROS® Immunodiagnostic Products TSH Calibrators
VITROS® Chemistry Products PHYT Slides
VITROS® Chemistry Products Calibrator Kit 9
VITROS® 5600 Integrated System |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | VITROS TSH Test System, VITROS PHYT Test System |
| Classification Name: | Thyroid Stimulating Hormone Test System (21 CFR 862.1690);
Diphenylhydantoin test system (21 CFR 862.3350); Calibrators
(21 CFR 862.1150); Discrete photometric chemistry analyzer for
clinical use (21 CFR 862.2160); 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 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 and VITROS 5600 Integrated
System for the quantitative measurement of thyroid stimulating
hormone (TSH) in human serum and plasma (EDTA or
Heparin). |
| | VITROS Chemistry Products PHYT Slides
For in vitro diagnostic use only.
VITROS Chemistry Products PHYT Slides quantitatively
measure phenytoin (PHYT) concentration in serum and plasma
using VITROS 250/350/950 and 5,1 FS Chemistry Systems and
the VITROS 5600 Integrated System. |
| | VITROS Chemistry Products Calibrator Kit 9
For in vitro diagnostic use only.
VITROS Chemistry Products Calibrator Kit 9 is used to calibrate
VITROS 250/350/950 and 5,1 FS Chemistry Systems and
the VITROS 5600 Integrated System for the quantitative
measurement of ACET, CRBM, DGXN, PHBR, and PHYT. |
| | VITROS 5600 Integrated System
For use in the in vitro quantitative, semi-quantitative, and
qualitative measurement of a variety of analytes of clinical
interest, using VITROS Chemistry Products Slides, VITROS
Chemistry Products MicroTip Reagents and VITROS
Immunodiagnostic Products Reagents. |

:

.

:

2

| Device description: | The VITROS Immunodiagnostic Products TSH assay and
VITROS Chemistry Products PHYT assay are intended for use
on the VITROS 5600 Integrated System. |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The VITROS 5600 Integrated System combines the existing
VITROS 5,1 FS Chemistry System (K031924) and the VITROS
ECi/ECiQ Immunodiagnostic System (K962919) into a single
system. All technology, methodologies and analytical methods
currently available on the existing two systems are available on
the new integrated system. |
| Substantial Equivalence: | The modified devices have the same intended use, fundamental
scientific technology and operating principle as the predicate
devices. The VITROS Immunodiagnostic Products TSH Assay
is substantially equivalent to the product previously cleared with
Premarket Notification number K964558. The VITROS
Chemistry Products PHYT Assay is substantially equivalent to
the product previously cleared with Premarket Notification
number K941142. |

!

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

Public Health Service

Food and Druq 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

OCT 2 8 2008

Re: K081543

Trade/Device Name: VITROS Immunodiagnostic Products TSH Reagent Pack VITROS Immunodiagnostic Products TSH Calibrators VITROS Chemistry Products PHYT Slides VITROS Chemistry Products Calibrator Kit 9 VITROS 5600 Integrated System

Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid Stimulating Hormone test system Regulatory Class: Class II Product Code: JLW, DIP, JJE, JIT Dated: September 24, 2008 Received: September 25, 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, listing 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 10gally 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 no (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.

Sean 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

510(k) Number (if known):

Device Name: VITROS Immunodiagnostic Products TSH Reagent Pack VITROS Immunodiagnostic Products TSH Calibrators VITROS Chemistry Products PHYT Slides VITROS Chemistry Products Calibrator Kit 9 VITROS 5600 Integrated 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 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 ECVECiQ Immunodiagnostic Systems and VITROS 5600 Integrated System for the quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA or Heparin).

VITROS Chemistry Products PHYT Slides

For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950 and 5,1 FS Chemistry Systems and the VITROS 5600 Integrated System.

VITROS Chemistry Products Calibrator Kit 9

For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950 and 5.1 FS Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, PHBR, and PHYT.

VITROS 5600 Integrated System

For use in the in vitro quantitative, semi-quantitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Bensen

on Sign-Off

്റ്ice of In Vitro Diagnostic Device