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

Intended 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 27, 2017

ABBOTT LABORATORIES LINDA SOHN REGULATORY AFFAIRS PROJECT MANAGER DEPT. 09AA, BLDG. AP08 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064

Re: K173122

Trade/Device Name: ARCHITECT Free T4 Regulation Number: 21 CFR 862.1695 Regulation Name: Free thyroxine test system Regulatory Class: II Product Code: CEC Dated: September 28, 2017 Received: September 29, 2017

Dear Linda Sohn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

k173122 Device Name ARCHITECT Free T4

Indications for Use (Describe)

The ARCHITECT Free T4 (FT4) assay is a Chemiluminescent Microparticle Immunoassay (CMA) for the quantitative determination of free thyroxine (Free T4) in human serum and plasma.

ARCHITECT Free T4 (FT4) assay is to be used as an aid in the assessment of thyroid status.

Type of Use (Select one or both, as applicable)

| <div> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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## I. 510(k) Summary

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date: September 28, 2017

## Applicant Name:

Linda Sohn, ADD, Regulatory Affairs Project Manager Abbott Laboratories Diagnostics Division Dept. 09AA, AP08 100 Abbott Park Road Abbott Park, IL 60064 Telephone Number: [phone] Fax Number: [phone]

### Device Name:

### Reagents

Classification Name: Free thyroxine test system Trade Name: Abbott ARCHITECT Free T4 Common Name: Radioimmunoassay, Free Thyroxine Governing Regulation: 21 CFR 862.1695 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: CEC

## Legally marketed device to which equivalency is claimed:

ARCHITECT Free T4 (cleared under k123379 on November 27, 2012)

### Intended Use/Indications for Use:

The ARCHITECT Free T4 (FT4) assay is a Chemiluminescent Microparticle

Immunoassay (CMIA) for the quantitative determination of free thyroxine (Free T4) in human serum and plasma.

ARCHITECT Free T4 (FT4) assay is to be used as an aid in the assessment of thyroid status.

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## Description of Device

The ARCHITECT Free T4 assay is a two-step immunoassay for the quantitative determination of free thyroxine (Free T4) in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex.

In the first step, sample and anti-T4 coated paramagnetic microparticles are combined. Free T4 (unbound) present in the sample binds to the anti-T4 coated microparticles. After washing, Ts acridinium-labeled conjugate is added to create a reaction mixture. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An inverse relationship exists between the amount of Free T4 in the sample and the RLUs detected by the ARCHITECT i System optics.

### Modification of Device:

This Special 510(k) modification of the ARCHITECT Free T4 assay consisted of proposed labeling change for reduced microparticle percent solids from 0.08% to 0.05% due to enhancement of our manufacturing process, and proposed labeling change for reduced measuring interval from 0.40 to 6.00 ng/dL to 0.40 to 5.00 ng/dL.

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# Similarities and Differences of Modified Device

The table below compares the modified device, (ARCHITECT Free T4) and the predicate device (ARCHITECT Free T4 [k123379]).

| Characteristics | Predicate Device (k123379) | Modified Device |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Intended Use / | The ARCHITECT Free T4 (FT4) assay is a chemiluminescent<br>microparticle immunoassay (CMIA) for the quantitative<br>determination of Free T4 in human serum and plasma. | |
| Indications for Use | ARCHITECT Free T4 (FT4) assay is to be used as an aid in the<br>assessment of thyroid status. | |
| Platform | ARCHITECT i System | |
| Methodology | Chemiluminescence (CMIA) | |
| Specimen Type | Serum and plasma | |
| Microparticles | Anti-T4 (sheep) coated<br>Microparticles in TRIS buffer<br>with sheep IgG stabilizers.<br>Preservative: sodium azide.<br>Percent solids: 0.08% | Same<br>Percent solids: 0.05% |
| Conjugate | T3 acridinium-labeled<br>Conjugate in MES buffer with<br>NaCl and Triton X-100<br>stabilizers. Preservative:<br>ProClin.<br>Minimum concentration: 0.2<br>ng/mL. | same |
| Calibrators | • 6 levels<br>• 0.0, 0.5, 1.0, 2.0, 3.5, 6.0<br>ng/dL<br>L-thyroxine in human serum | same |
| Measuring Interval | 0.40-6.00 ng/dL | 0.40-5.00 ng/dL |

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## Verification of Modification:

The nonclinical performance of the ARCHITECT Free T4 assay was demonstrated through the following studies:

- . Limit of Blank/Detection/Quantitation
- Precision (20-Day)
- . Precision at Limits of Measuring Interval
- Accuracy by Correlation
- . Accelerated Life Testing (ALT) Stability
- Reagent On Board Stability
- Linearity

The device passed all of the tests based on pre-determined acceptance criteria.

## Conclusion:

Substantial equivalence for the modified device, ARCHITECT Free T4 is claimed to the predicate device cleared in k123379, ARCHITECT Free T4. The modifications to the labeling, which consisted of proposed labeling change for reduced microparticle percent solids from 0.08% to 0.05%, and proposed labeling change for reduced measuring interval from 0.40 to 6.00 ng/dL to 0.40 to 5.00 ng/dL, has not changed the intended use, indications for use, nor has it altered the fundamental scientific technology of the device. Furthermore, no new risks or modes of control that affect the safety and effectiveness of the device were identified as a result of the proposed change.