FASTPACK TSH IMMUNOASSAY

K101390 · Qualigen, Inc. · JLW · Aug 13, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101390
• Device Name: FASTPACK TSH IMMUNOASSAY
• Applicant: Qualigen, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Aug 13, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Indications for Use

The FastPack® TSH Immunoassay is a paramagnetic particle immunoassay for the in-vitro quantitative determination of TSH in human serum or plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. FastPack® TSH Immunoassay is designed for use with the FastPack® System.

Device Story

FastPack TSH Immunoassay is a paramagnetic particle-based immunoassay used with the FastPack System. It measures TSH levels in human serum or plasma samples. The system automates the immunoassay process to provide quantitative results. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing thyroid or pituitary disorders, facilitating appropriate patient management.

Clinical Evidence

Bench testing only. Verification and validation activities performed to assess impact of new sample collection tube on assay performance, including precision, method comparison, limit of detection, interference, and linearity.

Technological Characteristics

Paramagnetic particle immunoassay; quantitative measurement of TSH; designed for use with the FastPack System; in-vitro diagnostic use.

Indications for Use

Indicated for the quantitative determination of thyroid stimulating hormone (TSH) in human serum to aid in the diagnosis of thyroid disease.

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.

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 K101390

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.) FastPack TSH Immunoassay (k052301)

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 to add another sample collection tube.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance characteristics, including precision, method comparison, limit of detection, interference and linearity.

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.