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

Intended 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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123379

# NOV 2 7 2012

# Attachment B 510(k) Summary (Summary of Safety and Effectiveness)

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.

## Applicant Name:

Jacek Gorzowski, Regulatory Affairs Project Manager

Regulatory Affairs

Abbott Laboratories Diagnostics Division

Dept. 9VA, AP5N-2

100 Abbott Park Road

Abbott Park, IL 60064

[e-mail]

## Device Name:

Classification Name: Radioimmunoassay, Free Thyroxine

Trade Name: Abbott ARCHITECT Free T4

Common Name: Radioimmunoassay, Free Thyroxine

Governing Regulation: 862.1695

Device Classification: Class II

Classification Panel: Clinical Chemistry

Product Code: CEC/JIT/JJX

## Legally marketed device to which equivalency is claimed:

k983417, Abbott ARCHITECT Free T4 (LN 7K65-01; 2-point calibration)

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## Intended Use of Device:

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

The ARCHITECT Free T4 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of free thyroxine (Free T4) in human serum and plasma when using the ARCHITECT Free T4 Reagent Kit.

The ARCHITECT Free T4 Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of free thyroxine (Free T4) in human serum and plasma when using the ARCHITECT Free T4 Reagent Kit.

#### Description of Device:

The ARCHITECT Free T4 assay is a two-step immunoassay to determine the presence 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 T 4 (unbound) present in the sample binds to the anti-T4 coated microparticles. After washing. T3 acridinium labeled conjugate is added in the second step. Pre-Trigger and Trigger Solutions are then 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 optical system.

The calibrators are devices intended for medical purposes for use in the ARCHITECT Free T 4 assay test system to establish points of reference that are used in the quantitative determination of values in the measurement of substances in human specimens. Free T4 measurements are used as an aid in the assessment of thyroid status.

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## Modification of Device:

This Special 510(k) modification of the ARCHITECT Free T4 assay consisted of changing the calibration from a 2-point calibration to a 6-point calibration.

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## Similarities and Differences of Modified Device:

The table below compares the new device, ARCHITECT Free T4 (LN 7K65-02; 6-point calibration), with the predicate device, ARCHITECT Free T4 (LN 7K65-01; 2-point calibration) (k983417).

| Attribute | Predicate Device<br>ARCHITECT Free T4<br>(2-point calibration)<br>LN 7K65-01, k983417 | New Device<br>ARCHITECT Free T4<br>(6-point calibration)<br>LN 7K65-02 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Intended Use | The ARCHITECT Free T4 (FT4)<br>assay is a Chemiluminescent<br>Microparticle Immunoassay<br>(CMIA) for the quantitative<br>determination of free thyroxine<br>(Free T4) in human serum and<br>plasma. The ARCHITECT Free T4<br>assay is to be used as an aid in the<br>assessment of thyroid status. | Same |
| | The ARCHITECT Free T4<br>Calibrators are for the calibration of<br>the ARCHITECT i System when<br>used for the quantitative<br>determination of free thyroxine<br>(Free T4) in human serum and<br>plasma when using the<br>ARCHITECT Free T4 Reagent Kit. | |
| | The ARCHITECT Free T4 Controls<br>are for the verification of the<br>accuracy and precision of the<br>ARCHITECT i System when used<br>for the quantitative determination of<br>free thyroxine (Free T4) in human<br>serum and plasma when using the<br>ARCHITECT Free T4 Reagent Kit. | |
| | | |
| Instrumentation | ARCHITECT i System | Same |
| Attribute | Predicate Device<br>ARCHITECT Free T4<br>(2-point calibration)<br>LN 7K65-01, k983417 | New Device<br>ARCHITECT Free T4<br>(6-point calibration)<br>LN 7K65-02 |
| Assay Reagents | Microparticles: Anti-T4 (sheep)<br>coated microparticles in TRIS<br>buffer with sheep IgG stabilizers.<br>Minimum concentration: 0.08%<br>solids. Preservative: antimicrobial<br>agent.<br><br>Conjugate: T3 acridinium-labeled<br>conjugate in MES buffer with NaCl<br>and Triton X-100 stabilizers.<br>Minimum concentration: 0.2 ng/mL.<br>Preservative: ProClin. | • Same |
| Free T4 Calibrators | • 2 levels<br>• 0.5 and 6.0 ng/dL L-thyroxine<br>in human serum | • 6 levels<br>• 0.0, 0.5, 1.0, 2.0, 3.5,<br>6.0 ng/dL L-thyroxine in<br>human serum |
| Calibrator<br>Composition | • Calibrators 1-2: L-thyroxine,<br>sodium salt pentahydrate (HPLC<br>grade)<br>• Calibrators 1-2: Diluent: Human<br>Serum<br>• Calibrators 1-2: Preservative:<br>Sodium Azide | • Calibrators B-F: Same<br>• Calibrators A-F: Diluent: Same<br>• Calibrators A-F: Preservative:<br>Same |
| Standardization | The calibrators are matched to an<br>Abbott internal reference standard.<br>This internal reference standard is<br>manufactured by gravimetric<br>methods based on the Free<br>Thyroxine calculation (FT4c) using<br>L-Thyroxine, sodium salt<br>pentahydrate (HPLC grade), at each<br>concentration, which depends on the<br>amount of Total T4 found in the<br>serum and the serum's T4 binding<br>capacity. | Same |
| Calibrator Range | 0.0–6.0 ng/dL | Same |
| Attribute | Predicate Device<br>ARCHITECT Free T 4<br>(2-point calibration)<br>LN 7K65-01, k983417 | New Device<br>ARCHITECT Free T 4<br>(6-point calibration)<br>LN 7K65-02 |
| Analytical Sensitivity | 0.4 ng/dL | Analytical sensitivity replaced by<br>LoQ. |
| LoB<br>LoD<br>LoQ | Not applicable | LoB: 0.22 ng/dL<br>LoD: 0.28 ng/dL<br>LoQ: 0.4 ng/dL |
| Dynamic Range/<br>Measuring Interval | 0.4–6.0 ng/dL | Same |
| Control<br>Composition | • Controls L, M, H: L-thyroxine,<br>sodium salt pentahydrate (HPLC<br>grade)<br>• Controls L, M, H: Diluent:<br>Human Serum<br>• Controls L, M, H: Preservative:<br>Sodium Azide | • Controls L, M, H: Same<br>• Controls L, M, H: Diluent: Same<br>• Controls L, M, H: Preservative:<br>Same |

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# Similarities and Differences of Modified Device (Continued):

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Similarities and Differences of Modified Device (Continued):

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## Verification/Validation of Modification:

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

- . Accuracy by Correlation
- . Accelerated Calibrator Stability
- . Real Time Calibrator Stability - In-Use (Open Vial)
- . Real Time Calibrator Stability - Intended Storage (Closed Vial)
- ◆ Limits of Blank/Detection/Quantitation (LoB/LoD/LoQ)
- Linearity *
- 20-Day Precision at the Limits of the Measuring Interval .
- 20-Day Precision to Verify the Product Requirements •
- 20-Day Precision for Native Samples .

## Conclusion:

Substantial equivalence for the modified device, ARCHITECT Free Ta (LN 7K65-02; 6-point calibration), is claimed to the predicate device cleared in k983417, ARCHITECT Free T4 (LN 7K65-01; 2-point calibration). The modification to the calibrators, which consisted of changing the calibration from a 2-point calibration to a 6-point calibration, has not changed the intended use, as described in the labeling, nor has it altered the fundamental scientific technology of the device.

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#### DEPARTMENT OF HEALTH & HUM AN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 27, 2012

Abbott Laboratories c/o Jacek Gorzowski 100 Abbott Park Road Dept. 9VA, AP5N-2 Abbott Park, IL 60064-3500

Re: kl23379

Trade/Device Name: Abbott ARCHITECT Free T4 Regulation Number: 21 CFR 862.1695 Regulation Name: Free thyroxine test system Regulatory Class: Class II Product Code: CEC, JIT, JJX Dated: October 30, 2012 Received: November 1, 2012

Dear Jacek Gorzowski:

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.

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 Part 801); 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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Page 2 - Jacek Gorzowski

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

#### Carol C. Benson for

Courtney H. Lias, Ph.D.

Director

Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

k 123379 510(k) Number (if known): Device Name: Abbott ARCHITECT Free T4 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. The ARCHITECT Free T4 assay is to be used as an aid in the assessment of thyroid status.

The ARCHITECT Free T , Calibrators are for the ARCHITECT i System when used for the quantitative determination of free thyroxine (Free T4) in human serum and plasma when using the ARCHITECT Free T4 Reagent Kit.

The ARCHITECT Free T4 Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of free Ta) in human serum and plasma when using the ARCHITECT Free T4 Reagent Kit.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Yung Chan

Division Vitro Diagnostics and Radiological Health Office of 510(k)