VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM

K081543 · Ortho-Clinical Diagnostics, Inc. · JLW · Oct 23, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081543
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Oct 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

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 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.

Device Story

Vitros 5600 Integrated System; combines Microslide and MicroTip processing centers from Vitros 5,1 FS Chemistry System with modified Microwell processing center from Vitros ECi/ECiQ. Device processes TSH and phenytoin assays; utilizes same reagents, consumables, and assay protocols as predicate systems. Modification increases Microwell assay throughput. Operated by laboratory personnel in clinical settings. Output provides quantitative diagnostic results for clinical decision-making regarding thyroid function and phenytoin therapeutic monitoring.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance equivalence to predicate systems.

Technological Characteristics

Integrated diagnostic system; combines Microslide, MicroTip, and Microwell processing centers. Uses same assay protocols, reagents, and consumables as predicate Vitros systems. Modification involves instrument configuration to increase Microwell assay throughput.

Indications for Use

Indicated for the quantitative measurement of TSH and phenytoin in human serum or plasma for diagnostic purposes.

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 Immunodiagnostic Products TSH reagent pack (k964558)
• Vitros Chemistry Products phenytoin slides (k941142)

Reference Devices

• Vitros 5,1 FS Chemistry System
• Vitros ECi/ECiQ

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 k081543

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, k941142 Vitros Chemistry Products phenytoin slides.
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 and phenytoin assays to a new instrument configuration, The Vitros 5600. The Microslide and MicroTip components the Vitros 5,1 FS Chemistry System were added to the Microwell components on the Vitros Immunodiagnostic System. The Microslide and Microtip processing centers are directly leveraged from the Vitros 5,1 FS Chemistry System. The Microwell processing center has been modified to increase the Microwell assay throughput compared to the Vitros ECi/ECiQ, while using the same assay protocols, reagents and consumables. The performance of the TSH and phenytoin assays was demonstrated on the new instrument configuration which is named the Vitros 5600 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.