ACCESS HYPERSENSITIVE HTSH ASSAY

K023093 · Beckman Coulter, Inc. · JLW · Nov 25, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023093
• Device Name: ACCESS HYPERSENSITIVE HTSH ASSAY
• Applicant: Beckman Coulter, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Nov 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Intended Use

The Access HYPERsensitive hTSH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, hTSH) levels in human serum and plasma using the Access® Immunoassay Systems.

Device Story

Access® HYPERsensitive hTSH assay is a paramagnetic particle, chemiluminescent immunoassay used on Access® Immunoassay Systems. It measures hTSH levels in human serum or plasma. The device is used in clinical laboratory settings by trained personnel. The system processes samples to provide quantitative hTSH results, which clinicians use to evaluate patient thyroid status and inform clinical decision-making regarding thyroid function.

Clinical Evidence

Bench testing only. A method correlation study was conducted comparing paired plasma and serum samples. Results demonstrated good correlation between the two sample types.

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Components include reagent pack, calibrators, and diluent. Requires substrate and wash buffers. Designed for use on Access® Immunoassay Systems.

Indications for Use

Indicated for in vitro quantitative measurement of hTSH in human serum or plasma for patients requiring evaluation of thyroid status.

Regulatory Classification

Identification

A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Predicate Devices

• Access HYPERsensitive hTSH assay (K925637)
• Access HYPERsensitive hTSH assay (K954825)

Submission Summary (Full Text)

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# 510(k) Summary

### [As required by 21 CFR 807.92]

**510(k) Number** K023093

Date Prepared:

| 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® HYPERsensitive hTSH assay |
|---------------------|-----------------------------------------------------------|
| Common Name | Thyroid stimulating hormone assay |
| Classification Name | Thyroid stimulating hormone test system (21 CFR 862.1690) |

# Device Description

The Access® HYPERsensitive hTSH assay consists of the reagent pack, calibrators, and diluent. Consumables required for the assay include substrate and wash buffers.

## Intended Use

The Access HYPERsensitive hTSH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, hTSH) levels in human serum and plasma using the Access® Immunoassay Systems.

## Substantial Equivalence Comparison

The Access HYPERsensitive hTSH assay is substantially equivalent to the previously cleared Access HYPERsensitive hTSH assay (K925637 and K954825). 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 HYPERsensitive hTSH assay. Study results demonstrate good correlation between the plasma and serum samples.

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# Conclusion

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k023093

Trade/Device Name: Access® HYPERsensitive hTSH on the Access® Immunoassay Systems Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: Class II Product Code: JLW; JIS Dated: September 17, 2002 Received: September 18, 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 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); 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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510(k) Number: K023093

Device Name: Access® HYPERsensitive hTSH on the Access® Immunoassay Systems

#### Indications:

The Access HYPERsensitive hTSH assay provides in vitro quantitative measurement of human thyroid stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH assay is indicated for use with patients where an evaluation of their thyroid status is desired.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

510ck) Number ___

Prescription Use (Per 21 CFR 801.109)

Over-The-CounterUse

(Optional Format 1-2-96)

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