MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY

K042281 · Beckman Coulter, Inc. · JLW · Sep 16, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042281
• Device Name: MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
• Applicant: Beckman Coulter, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Sep 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Intended Use

The Access® 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; in vitro diagnostic test for hTSH quantification in serum/plasma. Modification adds 'Fast hTSH' (second generation) protocol alongside existing 'third generation' test. Fast hTSH protocol utilizes smaller sample volume and reduced processing time. Device operates on Access immunoassay systems; used in clinical laboratories by trained personnel. Output provides hTSH concentration levels to assist clinicians in thyroid function assessment. Modification involves software-based Assay Protocol File (APF) update to enable dual-protocol capability without altering fundamental scientific technology.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements (21 CFR 820.30) to confirm performance of the new Fast hTSH assay protocol. Results met predetermined acceptance criteria.

Technological Characteristics

Paramagnetic particle, chemiluminescent immunoassay. Components include reagent pack, calibrators, diluent, substrate, and wash buffers. Operates on Access Immunoassay Systems. Supports dual-mode performance: 3rd generation (high sensitivity) and 2nd generation (fast turnaround).

Indications for Use

Indicated for the quantitative determination of human thyroid stimulating hormone (hTSH) in human serum and plasma.

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 (K023093)
• Access® HYPERsensitive hTSH Assay (K954825)
• Access® HYPERsensitive hTSH Assay (K925637)

Submission Summary (Full Text)

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SEP 1 6 2004

## Attachment D: 510(k) Summary

Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two white curved lines inside, followed by the words "BECKMAN" and "COULTER" stacked on top of each other. The text is in a bold, sans-serif font.

K042281

lmmunodiagnostic Development Center 1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084

| Applicant: | Beckman Coulter, Inc.<br>Immunodiagnostics Development Center<br>1000 lake Hazeltine Drive<br>Chaska, MN 55318 |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Barbara Stegmeier, RAC<br>Principal Consultant<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | August 23, 2004 |
| Trade Name: | Access® HYPERsensitive hTSH Assay |
| Product Classification<br>and Code: | II - JLW |
| Predicate Device: | Access® HYPERsensitive hTSH Assay - K023093, K954825,<br>K925637 |
| Device Description: | The Access® hTSH assay consists of the reagent pack and<br>calibrators. Other items needed to perform the assay include the<br>diluent, substrate and wash buffers. |
| Intended Use: | The Access®<br>hTSH Assay is a paramagnetic particle,<br>chemiluminescent immunoassay for the quantitative<br>determination of human thyroid-stimulating hormone<br>(thyrotropin, hTSH) levels in human serum and plasma using<br>the Access® Immunoassay Systems. |
| Summary of<br>Technological<br>Characteristics: | The assay has been modified to allow performance of a "2nd<br>generation" test (≤ 20% CV at 0.1 µlU/mL) in addition to the<br>exiting "3rd generation" test (≤ 20% CV at 0.01-0.02 µlU/mL).<br>The 2nd generation test requires a smaller sample size, has a<br>shorter incubation time and provides results in less time than the<br>3rd generation test. |
| Conclusion: | The modified Access® hTSH assay is substantially equivalent to<br>the previously cleared Access® hTSH assays. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 6 2004

Ms. Barbara Stegmeier Principal Consultant Beckman Coulter, Inc. Immunodiagnostic Development Center 1000 Lake Hazeltine Drive Chaska, MN 55318-1084

k042281 Re:

Trade/Device Name: Access HYPERsensitive hTSH Assay Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: Class II Product Code: JLW Dated: August 23, 2004 Received: August 24, 2004

Dear Ms. Stegmeier:

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 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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## Page 2

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, Ir Joursens on the promotion and advertising of your device, please contact the Office of Jn Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, U.S., DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K042281

Device Name: Access HYPERsensitive hTSH Assay

## Indications for Use:

The Access HYPERsensitive hTSH Assay provides in vitro quantitative measurement of the human thyroid-stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH Assay is indicated for use with patients where an assessment of their thyroid status is desired. This assay is capable of providing 3rd generation (HYPERsensitive hTSH) and/or the 2nd generation (Fast hTSH) results.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benson
Division Sign Off

Division Sign-On

Office of In Vitro Dlagn Device Evaluation an

5166K K04228