VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

K083173 · Ortho-Clinical Diagnostics · JLW · Dec 22, 2008 · Clinical Chemistry

Device Facts

• Record ID: K083173
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
• Applicant: Ortho-Clinical Diagnostics
• Product Code: JLW · Clinical Chemistry
• Decision Date: Dec 22, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1690
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

VITROS 3600 Immunodiagnostic System is a high-throughput clinical analyzer for in vitro diagnostic testing. It processes human serum and plasma samples using VITROS Immunodiagnostic reagent packs and calibrators. The system utilizes established immunoassay hardware and software subsystems shared with the VITROS 5600 Integrated System and VITROS ECi/ECiQ systems. It performs quantitative, semi-quantitative, and qualitative measurements of various clinical analytes. The device is intended for use in clinical laboratory settings by trained laboratory personnel. Output is provided as analyte concentrations, which clinicians use to aid in the differential diagnosis of thyroid and other diseases. The system design focuses on increased operating efficiency and throughput compared to previous VITROS models while maintaining identical analytical methodologies.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the use of identical technology, reagents, and analytical methods previously cleared for the VITROS ECi/ECiQ and VITROS 5600 systems.

Technological Characteristics

Microwell-based immunodiagnostic assay. The system utilizes a single metering arm for sample/reagent handling. The device is designed for integration into the Vitros 3600 platform, which performs immunodiagnostic assays. The fundamental scientific technology (immunodiagnostic microwell) is identical to the predicate.

Indications for Use

Indicated for the quantitative measurement of TSH in human serum and plasma to aid in the diagnosis of thyroid or pituitary disorders in adult and pediatric populations.

Regulatory Classification

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.

Predicate Devices

• Vitros Immunodiagostic Products TSH Reagent Pack (K964558)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k083173

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k964558 Vitros Immunodiagostic Products TSH Reagent Pack.

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for adding the TSH assay to a new instrument configuration, the Vitros 3600. This instrument is based on the Vitros 5600 but only performs immunodiagnostic assays (microwell) while the Vitros 5600 performs immunodiagnostic (microwell) and chemistry (microslide and microtip) assays. The Vitros 3600 also only has one metering arm, while the Vitros 5600 has two metering arms. The performance of the TSH assay was demonstrated on the new instrument configuration which is named the Vitros 3600 Integrated System.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.