3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

K981312 · Bayer Corp. · JLW · Jun 5, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981312
• Device Name: 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
• Applicant: Bayer Corp.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Jun 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Intended Use

This in vitro diagnostic method is intended to quantitatively measure thyroid stimulating hormone in human serum or plasma on the Bayer Immuno 1 System. Measurements of TSH, with a 3td Generation sensitivity of <20% total CV at 0.01 uIUmL to 0.02 µIU/mL (as defined by the American Thyroid Association), are used as an aid in the diagnosis of thyroid or pituitary disorders. This diagnostic method is not intended for use on any other system.

Device Story

The Bayer Immuno 1 3rd Generation TSH Assay is an in vitro diagnostic method for the quantitative measurement of thyroid stimulating hormone (TSH) in human serum or plasma. The assay is designed exclusively for use on the Bayer Immuno 1 System. It utilizes 3rd generation sensitivity, defined as <20% total CV at 0.01–0.02 µIU/mL, to assist clinicians in diagnosing thyroid or pituitary disorders. The device processes patient serum or plasma samples to provide TSH concentration values. Healthcare providers use these quantitative results to evaluate thyroid function and inform clinical decision-making regarding patient treatment. The assay demonstrates high specificity with negligible cross-reactivity to hCG, LH, and FSH.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (n=20 over 10 days) showing total CVs consistent with 3rd generation sensitivity requirements. Method comparison regression analysis performed against predicate devices (n=56 to 218 samples) yielded correlation coefficients (r) of 0.996–0.998. Specificity testing confirmed cross-reactivity <0.001% for hCG, LH, and FSH at high concentrations.

Technological Characteristics

In vitro diagnostic immunoassay for use on the Bayer Immuno 1 System. Employs automated analytical chemistry principles for TSH quantification. Performance characterized by 3rd generation sensitivity (<20% total CV at 0.01–0.02 µIU/mL).

Indications for Use

Indicated for quantitative measurement of TSH in human serum or plasma to aid in the diagnosis of thyroid or pituitary disorders in patients requiring clinical assessment of thyroid function.

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

• Bayer Immuno 1 TSH Assay
• Ciba-Corning ACS™ TSH-3 Assay
• Boehringer-Mannheim Elecsys® TSH Assay

Submission Summary (Full Text)

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JUN 5 1898

# Summary of Safety and Effectiveness

# 3rd Generation TSH Method for the Bayer Immuno 1™ System

Listed below is a comparison of the performance of the Bayer Immuno 1™ 3rd Generation TSH (3Gen TSH) method and similar devices granted clearance of substantial equivalence (Bayer Immuno 1 TSH Assay, (Chiron) Ciba-Corning ACS™ TSH-3 Assay and (Roche) Boehringer-Mannheim Elecsys® TSH Assay). The information below was extracted from the Bayer Immuno 1 3rd Generation TSH method sheet and Package Inserts from the other three methods.

### Intended Use

This in vitro diagnostic method is intended to quantitatively measure thyroid stimulating hormone (TSH) in human serum or plasma with 3d generation sensitivity on the Bayer Immuno 1 System. Measurements of TSH, produced by the anterior pituitary, are used in the diagnosis of thyroid or pituitary disorders.

| Bayer Corporation | | | | Ciba-Corning | | Boehringer-<br>Mannheim | | |
|-------------------------------------------------|----------------------------|----------------------------|------------------------------|--------------------|--------------------|-------------------------|--------------------|------|
| Bayer Immuno 1 | | ACS:180 | | Elecsys | | | | |
| | 3GEN TSH | TSH | TSH-3 | TSH | | | | |
| Part Number<br>Reagents<br>Calibrators | T01-4038-51<br>T03-4039-01 | T01-2942-51<br>T03-3568-01 | 570056<br>(rgnts and calibs) | 1731459<br>1731483 | | | | |
| Expected Values | 0.31 - 4.7 µIU/mL | 0.47 - 6.9 µIU/mL | 0.35 - 5.5 µIU/mL | 0.25 - 4.2 µIU/mL | | | | |
| Precision (within-run)<br>(n = 20 over 10 days) | mean | % CV | mean | % CV | mean | % CV | mean | % CV |
| | 0.008 | 12.6 | 0.1 | 8.0 | 0.026 | 10.7 | 0.084 | |
| | 0.019 | 4.1 | 1.3 | 5.5 | 0.077 | 6.5 | 0.091 | 2.1 |
| | 0.031 | 3.7 | 9.0 | 1.7 | 0.668 | 3.9 | 0.34 | 8.6 |
| | 0.50 | 4.0 | 22.5 | 1.6 | 4.81 | 3.3 | 2.45 | 1.9 |
| | 4.68 | 2.8 | | | 33.503 | 3.2 | 3.96 | 1.8 |
| | 29.26 | 1.4 | | | 97.021 | 4.0 | 10.67 | 1.5 |
| | 59.03 | 1.4 | | | | | | |
| Precision (total)<br>(n = 20 over 10 days) | 0.008 | 12.6 | 0.1 | 13.0 | 0.026 | 15.8 | 0.084 | 5.4 |
| | 0.019 | 5.1 | 1.3 | 6.3 | 0.077 | 8.4 | 0.091 | 3.3 |
| | 0.031 | 3.7 | 9.0 | 2.0 | 0.668 | 4.1 | 0.34 | 8.7 |
| | 0.50 | 4.2 | 22.5 | 1.8 | 4.810 | 3.5 | 2.45 | 2.2 |
| | 4.68 | 3.1 | | | 33.503 | 3.9 | 3.96 | 3.6 |
| | 29.26 | 4.1 | | | 97.021 | 5.0 | 10.67 | 1.8 |
| | 59.03 | 1.8 | | | | | | |
| Regression Equation | | | y = 0.980x - 0.011 | | y = 0.928x - 0.021 | | y = 0.988x - 0.122 | |
| where:<br>y = | 3Gen TSH | | | | | | | |
| x = | | | TSH (2nd Gen) | | ACS:180 | | Elecsys | |
| n = | | | 218 | | 203 | | 56 | |
| r = | | | 0.998 | | 0.996 | | 0.997 | |
| Sy.x = | | | 1.655 | | 0.676 | | 1.049 | |
| range = | | | 0.05 - 104.5 | | 0.01 - 68.1 | | 0.01 - 65.3 | |

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Specificity: Cross Reactants Spiked into Normal Human Serum Pools.

| Compound | Test Concentration<br>(µIU/mL) | Crossreactivity<br>(%) |
|------------------------------------|--------------------------------|------------------------|
| human Chorionic Gonadotropin (hCG) | 250,000 | < 0.001 |
| Leutinizing Hormone (LH) | 2,000 | < 0.001 |
| Follicle Stimulating Hormone (FSH) | 2,000 | < 0.001 |

Gabriel J. Muraca Jr.
Gabriel J. Muraca, Jr.

Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

4/6/98
Date

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

2 1898 JUN

Gabriel Muraca, Jr. Manager Regulatory Affairs Baver Corporation 511 Benedict Avenue 10591-5097 Tarrytown, New York

K981312 Re: 3rd Generation TSH Assay for the Bayer Immuno 1™ System Regulatory Class: I & II Product Code: JLW, JIS, JJX April 7, 1998 Dated: Received: April 10, 1998

Dear Mr. Muraca:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K981312

#### Baver Immuno 1™ System Device Name: 3rd Generation Thyroid Stimulating Hormone (TSH) Assay

Indications For Use:

This in vitro diagnostic method is intended to quantitatively measure thyroid stimulating hormone in human serum or plasma on the Bayer Immuno 1 System. Measurements of TSH, with a 3td Generation sensitivity of <20% total CV at 0.01 uIUmL to 0.02 µIU/mL (as defined by the American Thyroid Association), are used as an aid in the diagnosis of thyroid or pituitary disorders.

This diagnostic method is not intended for use on any other system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use **__**

Optional Format 1-2-96
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K981312