ABBOTT ARCHITECT FREE T4

K123379 · Abbott Laboratories · CEC · Nov 27, 2012 · Clinical Chemistry

Device Facts

• Record ID: K123379
• Device Name: ABBOTT ARCHITECT FREE T4
• Applicant: Abbott Laboratories
• Product Code: CEC · Clinical Chemistry
• Decision Date: Nov 27, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1695
• Device Class: Class 2

Indications for Use

The Abbott ARCHITECT Free T4 assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of free thyroxine (free T4) in human serum and plasma on the ARCHITECT i System. The ARCHITECT Free T4 assay is intended to be used as an aid in the assessment of thyroid status.

Device Story

The ARCHITECT Free T4 assay is a two-step Chemiluminescent Microparticle Immunoassay (CMIA) performed on the ARCHITECT i System. Input consists of human serum or plasma samples. In the first step, samples are combined with anti-T4 coated paramagnetic microparticles; free T4 binds to the microparticles. In the second step, T3 acridinium-labeled conjugate is added. Pre-Trigger and Trigger solutions are introduced, producing a chemiluminescent reaction measured as relative light units (RLUs). The system uses an inverse relationship between Free T4 concentration and RLUs. The device is used in clinical laboratory settings by trained technicians. Output is a quantitative Free T4 value used by physicians to assess thyroid status. The modification involves transitioning from a 2-point to a 6-point calibration curve to improve assay performance.

Clinical Evidence

No clinical data. Performance was demonstrated through nonclinical bench testing, including accuracy by correlation, accelerated and real-time calibrator stability, LoB/LoD/LoQ determination, linearity, and 20-day precision studies.

Technological Characteristics

Chemiluminescent microparticle immunoassay (CMIA); automated analyzer platform (ARCHITECT i System); quantitative measurement; 6-point calibration.

Indications for Use

Indicated for the quantitative determination of free thyroxine (free T4) in human serum and plasma to aid in the assessment of thyroid status.

Regulatory Classification

Identification

A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Predicate Devices

• Abbott ARCHITECT Free T4 (k983417)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k123379

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.) Abbott ARCHITECT Free T₄ – k983417.

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: Modification to the calibrator set from a two-point calibration to a 6-point calibration.

4. Comparison Information (similarities and differences) to applicant’s legally marketed predicate device including, labeling, intended use, physical characteristics, and comparison analysis. Studies performed include method comparison, linearity, precision, and limits of detection.

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.