Abbott ARCHITECT Total T4 Calibrators

K151566 · Abbott Laboratories · JIT · Jul 10, 2015 · Clinical Chemistry

Device Facts

• Record ID: K151566
• Device Name: Abbott ARCHITECT Total T4 Calibrators
• Applicant: Abbott Laboratories
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jul 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

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

Device Story

ARCHITECT Total T4 Calibrators are liquid, ready-to-use human serum-based calibrators containing L-Thyroxine at six specific concentrations (0.0 to 24.0 µg/dL). Used in clinical laboratory settings on ARCHITECT i System analyzers (i2000, i2000SR, i1000SR) to establish reference points for the quantitative measurement of Total T4. The healthcare provider uses the resulting assay values to assess patient thyroid status. The device provides standardized reference material to ensure accurate quantification of patient samples.

Clinical Evidence

Bench testing only. Stability studies were conducted per CLSI EP25-A guidelines. Real-time stability for closed vials was validated up to 14 months at 2-8°C. In-use (open vial) stability was validated up to 12 months at 2-8°C. Value assignment was verified by running new lots on three instruments with 15 replicates per run, meeting predetermined acceptance criteria.

Technological Characteristics

Human serum-based calibrators containing L-Thyroxine and sodium azide preservative. Six-point calibration levels (0.0, 3.0, 6.0, 12.0, 18.0, 24.0 µg/dL). Standardized against Abbott internal reference standards derived from USP L-Thyroxine via gravimetric methods. Ready-to-use liquid form factor. Compatible with ARCHITECT i System analyzers.

Indications for Use

Indicated for the calibration of the ARCHITECT i System for the quantitative determination of thyroxine (Total T4) in human serum and plasma to aid in the assessment of thyroid status.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

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

July 10, 2015

ABBOTT LABORATORIES LISA LUKOWSKI REGULATORY AFFAIRS PROJECT MANAGER 100 ABBOTT PARK ROAD, DEPT 9VA, AP8-I ABBOTT PARK IL 60064

Re: K151566

Trade/Device Name: ARCHITECT Total T4 Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: June 9, 2015 Received: June 10, 2015

Dear Lisa Lukowski:

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.

{1}------------------------------------------------

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/Resourcesfor You/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.

# Courtney

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

#### k151566

Device Name ARCHITECT Total T4 Calibrators

Indications for Use (Describe)

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{3}------------------------------------------------

#### 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.

## I. Applicant Name

Abbott Laboratories Dept. 9V6, AP8-1 100 Abbott Park Road Abbott Park, IL 60064

Primary contact person:

Lisa Lukowski, ADD, Regulatory Affairs Project Manager Phone: [phone] Fax: [phone] E-Mail: [e-mail]

Secondary contact person:

Mary Caren Murawski, Associate Director of Regulatory Affairs Phone: [phone] Fax: [phone] E-Mail: [e-mail]

Date Summary prepared: July 9, 2015

## II. Device Name

Trade Name: ARCHITECT Total T4 Calibrators Device Classification: Class II Classification Name: Calibrator, Secondary Governing Regulation: 862.1150 Code: JIT

Classification Panel: Clinical Chemistry

510(k) Number: k151566

## III. Predicate Device

ARCHITECT Total T4 Calibrators (k983440)

{4}------------------------------------------------

# IV. Description of the Device

The calibrators are devices intended for medical purposes for use in the ARCHITECT Total T4 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. Total T4 measurements are used as an aid in the assessment of thyroid status.

The calibrators are designed to be used on the ARCHITECT i System (i 2000, and i 10005R) with the ARCHITECT Total T4 Reagents.

ARCHITECT Total T4 Calibrator kit contains:

| Component | Number of Bottles × Volume |
|----------------------|----------------------------|
| Calibrator A (Cal A) | 1 × 4 mL |
| Calibrator B (Cal B) | 1 × 4 mL |
| Calibrator C (Cal C) | 1 × 4 mL |
| Calibrator D (Cal D) | 1 × 4 mL |
| Calibrator E (Cal E) | 1 × 4 mL |
| Calibrator F (Cal F) | 1 × 4 mL |

- . ARCHITECT Total T4 Calibrator A contains human serum. Preservative: Sodium Azide.
- . ARCHITECT Total T4 Calibrators B-F contain different concentrations of T4 prepared in human serum. Preservative: Sodium Azide.

The ARCHITECT Total T4 Calibrators are prepared to target the following concentrations:

| Component | Concentration<br>(ug/dL) | Concentration<br>(nmol/L) |
|----------------------|--------------------------|---------------------------|
| Calibrator A (Cal A) | 0.0 | 0.0 |
| Calibrator B (Cal B) | 3.0 | 38.6 |
| Calibrator C (Cal C) | 6.0 | 77.2 |
| Calibrator D (Cal D) | 12.0 | 154.4 |
| Calibrator E (Cal E) | 18.0 | 231.7 |
| Calibrator F (Cal F) | 24.0 | 308.9 |

{5}------------------------------------------------

Value Assignment:

The ARCHITECT Total T4 (TT4) calibrators are prepared using a stock solution and then value assigned using primary calibrators (Abbott internal reference standards prepared using USP material). The TT4 calibrator values must meet the sponsor's predetermined acceptance criteria within a set specification, determined by the manufacturer. Each new TT4 calibrator lot is value assigned prior to use. Before each lot is released, the TT 4 calibrators are run on 3 instruments, 1 run per instrument 15 replicates per run. The observed values must meet the manufacture's acceptance criteria.

# V. Intended Use of the Device

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

# VI. Summary of Technological Characteristics

The following table provides the similarities and differences between the candidate (ARCHITECT Total T4) and the predicate device (ARCHITECT Total T4, k983440).

| Attribute | Predicate Device<br>ARCHITECT Total T4 Calibrators<br>(2-Point Calibration)<br>k983440 | Candidate Device<br>ARCHITECT Total T4 Calibrators<br>(6-Point Calibration)<br>k151566 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ARCHITECT Total T4<br>Calibrators are for the calibration<br>of the ARCHITECT <i>i</i> System<br>when used for the quantitative<br>determination of thyroxine (Total<br>T4) in human serum and plasma. | Same |
| Instrumentation | ARCHITECT <i>i</i> System ( <i>i</i> 2000SR,<br><i>i</i> 2000, and <i>i</i> 1000SR) | Same |
| Attribute | Predicate Device<br>ARCHITECT Total T4 Calibrators<br>(2-Point Calibration)<br>k983440 | Candidate Device<br>ARCHITECT Total T4 Calibrators<br>(6-Point Calibration)<br>k151566 |
| Total T4<br>Calibrators | 2 levels 0.0 and 18.0 µg/dL L-Thyroxine in human serum | 6 levels 0.0, 3.0, 6.0, 12.0, 18.0, and 24.0 µg/dL L-Thyroxine in human serum |
| Calibrator<br>Composition | Calibrator 1:<br>Analyte: None<br>Diluent: Human Serum<br>Preservative: Sodium Azide Calibrator 2:<br>Analyte: L-Thyroxine<br>Diluent: Human Serum<br>Preservative: Sodium Azide | Calibrator A:<br>Analyte: None<br>Diluent: Human Serum<br>Preservative: Sodium Azide Calibrators B-F:<br>Analyte: L-Thyroxine<br>Diluent: Human Serum<br>Preservative: Sodium Azide |
| Standardization | The calibrators are matched to an<br>Abbott internal reference standard.<br>This internal reference standard is<br>manufactured by gravimetric<br>methods using USP reference<br>L-Thyroxine. | Same |
| Storage and<br>Stability | The calibrators are stable until the<br>expiration date when stored and<br>handled as directed at 2-8°C. | The expiration date is 12 months<br>from the date opened when stored<br>and handled as directed. Do not<br>exceed the lot expiration date<br>printed on the bottle.<br>The calibrators are stable until the<br>expiration date when stored and<br>handled as directed. |
| Preparation for<br>Use | Ready to use | Same |

#### Comparison of ARCHITECT Total T4 to Predicate ARCHITECT Total T4 Calibrators

{6}------------------------------------------------

# Comparison of ARCHITECT Total T4 to Predicate ARCHITECT Total T4 Calibrators

# Stability Results:

Stability studies for the ARCHITECT Total T4 calibrators were performed based on guidance from the Clinical Laboratory and Standards Institute (CLSI) document EP25-A.

{7}------------------------------------------------

#### In-Use Condition (Open Vial):

Stability of the ARCHITECT Total T4 Calibrators was evaluated. At the baseline time point (0) and each subsequent time point (1, 2, 3, 4, 6, 9 and 12 months) the on-test calibrator vials are opened and squeezed to ensure good air exchange, then inverted and squeezed to release a minimum of 8 drops of material from each vial. The vials are then closed and stored at 2 to 8°C until the next time point. In-use testing was performed using a minimum of 10 replicates each of the on-test calibrators, reference controls, and reference panel with the designated reference reagents. The time point results were evaluated against the stability limit evaluation criteria. The results support the following stability claim for the ARCHITECT Total T4 Calibrators: 12 months at 2 - 8°C.

### Intended Storage Condition (Closed Vial):

The stability for the ARCHITECT Total T4 Calibrators was evaluated using real-time stability study. For the real time stability study, three lots of test materials are stored at 2 – 8°C. Samples at time-points 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 months were tested and evaluated against the stability limit evaluation criteria. The results support the following stability claim for the ARCHITECT Total T4 Calibrators: 14 months at 2 – 8°C.

#### Standardization

The calibrators are matched to an Abbott internal reference standard. This internal reference standard is manufactured by gravimetric methods using USP reference L-Thyroxine.

#### VII. Conclusion

Substantial equivalence for the candidate device, ARCHITECT Total T4 Calibrators, is claimed to the predicate device cleared in k983440, ARCHITECT Total T4 Calibrators. The modifications to the calibrators have not changed the intended use, as described in its labeling, nor have the modifications altered the fundamental scientific technology of this device.