Abbott Architect Free T4

K173122 · Abbott Laboratories · CEC · Oct 27, 2017 · Clinical Chemistry

Device Facts

• Record ID: K173122
• Device Name: Abbott Architect Free T4
• Applicant: Abbott Laboratories
• Product Code: CEC · Clinical Chemistry
• Decision Date: Oct 27, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1695
• Device Class: Class 2

Indications for Use

The ARCHITECT Free T4 reagent 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. Free T4 measurements are used in the diagnosis and treatment of thyroid diseases.

Device Story

ARCHITECT Free T4 reagent; chemiluminescent microparticle immunoassay (CMIA) for quantitative free T4 measurement in human serum/plasma. Modification: transition from Automated Microparticle Processing System (AMPS) to Magnetic Separation for antibody coating; reduction of microparticle percent solids (0.08% to 0.05%); adjustment of measuring interval (0.40–5.00 ng/dL). Used on ARCHITECT i System in clinical laboratory settings. Provides quantitative results to clinicians for thyroid disease diagnosis and treatment monitoring.

Clinical Evidence

Bench testing only. Submitter provided verification and validation activities based on risk analysis to confirm that modifications to the microparticle coating process, solids concentration, and measuring interval did not adversely affect device performance or fundamental scientific technology.

Technological Characteristics

Chemiluminescent microparticle immunoassay (CMIA). Modification: Magnetic separation process for antibody coating; microparticle solids reduced to 0.05%. Measuring interval: 0.40 to 5.00 ng/dL. System: ARCHITECT i System.

Indications for Use

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

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

• ARCHITECT Free T4 reagent (k123379)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER k173122

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.

k123379, ARCHITECT Free T4 reagent.

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 is for the following items:

a. Change the microparticle coating process from Automated Microparticle Processing System (AMPS) to Magnetic Separation to increase the antibody coating concentration on the microparticle.

b. A reduction of the ARCHITECT Free T4 assay microparticle percent solids from 0.08% to 0.05%.

c. The changing of measuring interval from 0.40 to 6.00 ng/dL to 0.40 to 5.00 ng/dL.

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

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.