MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY

K042281 · Beckman Coulter, Inc. · JLW · Sep 16, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042281
• Device Name: MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
• Applicant: Beckman Coulter, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Sep 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Indications for Use

The Access® hTSH Assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, hTSH) levels in human serum and plasma using the Access® Immunoassay Systems.

Device Story

Access HYPERsensitive hTSH Assay; in vitro diagnostic test for hTSH quantification in serum/plasma. Modification adds 'Fast hTSH' (second generation) protocol alongside existing 'third generation' test. Fast hTSH protocol utilizes smaller sample volume and reduced processing time. Device operates on Access immunoassay systems; used in clinical laboratories by trained personnel. Output provides hTSH concentration levels to assist clinicians in thyroid function assessment. Modification involves software-based Assay Protocol File (APF) update to enable dual-protocol capability without altering fundamental scientific technology.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements (21 CFR 820.30) to confirm performance of the new Fast hTSH assay protocol. Results met predetermined acceptance criteria.

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Components include reagent pack, calibrators, diluent, substrate, and wash buffers. Operates on Access Immunoassay Systems. Supports dual-mode performance: 3rd generation (high sensitivity) and 2nd generation (fast turnaround).

Indications for Use

Indicated for the quantitative determination of human thyroid stimulating hormone (hTSH) in human serum and plasma.

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

• Access® HYPERsensitive hTSH Assay (K023093)
• Access® HYPERsensitive hTSH Assay (K954825)
• Access® HYPERsensitive hTSH Assay (K925637)

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 K042281

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.) k023093
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.
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 a modification of the Access HYPERsensitive hTSH Assay to allow performance of a "second generation" test in addition to the current "third generation" test.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and an assay modification in which a second Assay Protocol File (APF) allows a "second generation" assay. This assay requires a smaller sample volume and provides results in a shorter time. The name of the second generation assay is Fast hTSH.
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.