ACCESS TOTAL T4 ASSAY

K023369 · Beckman Coulter, Inc. · KLI · Dec 9, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023369
• Device Name: ACCESS TOTAL T4 ASSAY
• Applicant: Beckman Coulter, Inc.
• Product Code: KLI · Clinical Chemistry
• Decision Date: Dec 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1700
• Device Class: Class 2

Intended Use

The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access® Immunoassay Systems.

Device Story

Access Total T4 assay; paramagnetic particle, chemiluminescent immunoassay; measures total thyroxine (T4) levels in human serum or plasma. Used on Access Immunoassay Systems in clinical laboratory settings. Input: patient serum or plasma samples. Process: automated immunoassay reaction; chemiluminescent detection. Output: quantitative T4 concentration. Healthcare providers use results to evaluate patient thyroid status; aids in clinical decision-making regarding thyroid function. Benefits: provides diagnostic information for thyroid-related conditions.

Clinical Evidence

Bench testing only. Method correlation study conducted using paired plasma and serum samples to validate the inclusion of plasma as a sample type. Results demonstrated good correlation between plasma and serum samples.

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Components include reagent pack, calibrators, substrate, and wash buffers. Designed for use on Access Immunoassay Systems. Quantitative measurement principle.

Indications for Use

Indicated for in vitro quantitative measurement of total thyroxine (T4) in human serum or plasma for patients requiring evaluation of thyroid status.

Regulatory Classification

Identification

A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

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.

Predicate Devices

• Access Total T4 assay (K926475)

Submission Summary (Full Text)

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# 510(k) Summarv

[As required by 21 CFR 807.92]

**510(k) Number** K023369

Date Prepared: 10/07/2002

| Submitter | Contact Person |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Beckman Coulter, Inc<br>Diagnostics Division<br>1000 Lake Hazeltine Drive<br>Chaska, MN 55318 | Denise Thompson<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |

#### General Information

| Trade Name | Access® Total T4 |
|---------------------|-----------------------------------------------|
| Common Name | Total thyroxine assay |
| Classification Name | Total thyroxine test system (21 CFR 862.1700) |

### Device Description

The Access® Total T4 assay consists of the reagent pack and calibrators. Consumables required for the assay include substrate and wash buffers.

#### Intended Use

The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access® Immunoassay Systems.

# Substantial Equivalence Comparison

The Access Total T4 assay is substantially equivalent to the previously cleared Access Total T4 assay (K926475). Both assays utilize the same methodology, are the same product type, and are quantitative. The subject and predicate assays include the same components. The only difference between the two assays is that the sample type has been expanded to include human plasma samples.

# Supporting Data

To demonstrate substantial equivalence, a method correlation study, using paired plasma and serum samples, was conducted using the Access Total T4 assay. Study results demonstrate good correlation between the plasma and serum samples.

# Conclusion

The information provided in this submission supports a substantial equivalence determination, and therefore 510(k) premarket notification clearance of the Access Total T4 assay.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administratio 2098 Gaither Road ockville MD 20850

Ms. Denise Thompson Regulatory Affairs Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084

Re:

k023369 Trade/Device Name: Access® Total T4 on the Access® Immunoassay Systems Regulation Number: 21 CFR 862.1700 Regulation Name: Total thyroxine test system Regulatory Class: Class II Product Code: KLI: JIS Dated: October 7, 2002 Received: October 8, 2002

Dear Ms. Thompson:

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. Iisting 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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 anv 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### Indications Statemer

Page 1 of 1

510(k) Number: K023369

Device Name:

Access® Total T4 on the Access® Immunoassay Systems

#### Indications:

The Access Total T4 assay provides in vitro quantitative measurement of total thyroxine (T4) levels in human serum or plasma. The Access Total T4 assay is indicated for use with patients where an evaluation of their thyroid status is desired.

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