TSH-CTK-3 IRMA

K041014 · DiaSorin, Inc. · JLW · Jul 14, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041014
• Device Name: TSH-CTK-3 IRMA
• Applicant: DiaSorin, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Jul 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Intended Use

The TSH-CTK-3 is an immunoradiometric assay (IRMA) for the quantitative determination of Thyroid Stimulating Hormone(Thyrotropin) in human serum. Measurements of TSH levels are used as an aid in the diagnosis of thyroid and pituitary disorders.

Device Story

TSH-CTK-3 is an immunoradiometric assay (IRMA) for quantitative TSH measurement in human serum. Device utilizes two monoclonal antibodies: one labeled with Iodine-125 (tracer) and one immobilized on tube inner surface. During incubation, antibodies form sandwich-type complex with TSH in sample. Unbound tracer removed via wash step; radioactivity of bound fraction measured. Radioactivity is directly proportional to TSH concentration. Standard curve constructed using known TSH standards (calibrated against WHO 2nd IRP 80/558) to determine unknown sample values. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing thyroid and pituitary disorders.

Clinical Evidence

Bench testing only. Performance evaluated via precision (intra-assay CV 2-10.6%, inter-assay CV 5-13%), linearity (r=0.998), and recovery (97-101%). Analytical sensitivity is 0.04 mU/L; functional sensitivity is 0.09 mU/L. Method comparison against predicate (n=95) yielded r=0.99. Interference testing performed for hemoglobin, bilirubin, cholesterol, triglycerides, and HAMA. Reference range established using 100 healthy adults (mean 1.35 mU/L, range 0.25–3.51 mU/L).

Technological Characteristics

Quantitative immunoradiometric assay (IRMA). Components: mouse monoclonal anti-TSH antibody-coated tubes, 125I-labeled mouse monoclonal anti-TSH tracer. Energy source: gamma counter for radioactivity detection. Standards: 7-level human serum-based calibrators, traceable to WHO 2nd IRP 80/558. Controls: 3-level human serum-based. Complies with NCCLS guidelines EP6-A (linearity), EP5-A (precision), and EP7-A (interference).

Indications for Use

Indicated for the quantitative determination of TSH in human serum to aid in the diagnosis of thyroid or pituitary disorders in patients. For professional use only in clinical laboratory settings.

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

• Ventrex hTSH 125I IRMA (k920856)

Submission Summary (Full Text)

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K041014 72

## JUL 1 4 2004

SUBMITTED BY: DiaSorin Inc.

510(k) Summary

David Ikeda

1951 Northwestern Ave. P.O. Box 285 Stillwater, MN 55082-0285 651.351.5592 Voice 651.351.5669 Fax March 31, 2004

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.

| NAME OF DEVICE: | |
|-------------------------|-------------------------------------------------------------------------------------|
| Trade Name | TSH-CTK-3 |
| Common Name/Description | Immunoradiometric assay (IRMA) for the<br>quantitative determination of Thyrotropin |
| Classification Name: | Thyroid Stimulating Hormone Test System |
| PREDICATE DEVICE: | Ventrex hTSH 125I IRMA |

INTENDED USE: The TSH-CTK-3 is an immunoradiometric assay (IRMA) for the quantitative determination of Thyroid Stimulating Hormone(Thyrotropin) in human serum. Measurements of TSH levels are used as an aid in the diagnosis of thyroid and pituitary disorders.

DEVICE DESCRIPTION: The TSH-CTK-3 is an immunoradiometric assay for the quantitative determination of thyrotropin (TSH) in human serum. Two monoclonal antibodies recognizing different binding sites on the antigen (intact hTSH and ß subunit of TSH) are used in excess. The monoclonal antibody to intact hTSH is labeled with Iodine-125 (tracer). The other monoclonal antibody to the ß subunit of TSH is immobilized on the inner surface of the tube (coated tube system). During the incubation both antibodies react with TSH molecules of the sample to form a sandwich-type complex bound to the tube (bound fraction B). Unbound tracer is removed with a wash step. After the washing step the radioactivity of the tubes is measured. The radioactivity measured is directly proportional to the TSH concentration of the respective sample. Using samples of known TSH concentration (standards) a radioactivity-concentration-profile (standard curve) is constructed by which TSH values of unknown samples can be determined by means of their respective radioactivity. TSH concentrations in terms of mU TSH/L are calibrated against WHO 2nd IRP 80/558.

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| TECHNOLOGICAL COMPARISON TO PREDICATE: | | |
|----------------------------------------|--|--|
|----------------------------------------|--|--|

| Feature | Ventrex hTSH 125I IRMA (K920856) | TSH-CTK-3 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte | Thyroid Stimulating Hormone(hTSH) | Thyroid Stimulating Hormone (hTSH) |
| Intended<br>Use | FOR <i>in vitro</i> DIAGNOSTIC USE.<br>The Ventrex hTSH 125I IRMA kit is to be<br>used for the quantitative<br>determination of TSH (thyroid stimulating<br>hormone) concentration<br>in serum. | FOR <i>in vitro</i> DIAGNOSTIC USE.<br>The DiaSorin TSH-CTK-3 is an immuno-<br>radiometric assay for the determination of<br>thyrotropin(TSH) in human serum.<br>Measurements of TSH are used as an aid in<br>the diagnosis of thyroid and pituitary<br>disorders. |
| Assay<br>Type | IRMA | IRMA |
| Coated | Mouse Monoclonal Anti-hTSH | Mouse Monoclonal Anti-Thyrotropin<br>antibody |
| Tube<br>Tracer | 125I Goat Anti-hTSH | 125I Mouse Monoclonal Anti-Thyrotropin<br>antibody |
| Standards | Eight levels, porcine serum based with<br>nominal concentrations ranging from<br>0.125-100mIU/L. Standardized<br>against the World Health Organization<br>(WHO) Reference Program 80/558. | Seven levels, human serum based with<br>nominal concentrations ranging from<br>0.02-0.92mU/L. Standardized against<br>the World Health Organization (WHO)<br>Reference Program 80/558. |
| Kit<br>Controls | None provided with the kit. | Three levels, human serum based. |

PERFORMANCE DATA: A summary of performance data is shown below.

| Parameter | Performance Results |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sensitivity (Analytical) | 0.04 mU/L |
| Sensitivity (Functional) | 0.09 mU/L |
| Total Precision(%CV) | 2% - 13% |
| Recovery(mean) | 98.7% +/- 1.4% |
| Linearity | y = 0.93x + 0.52, r = 0.998 |
| Linearity of Dilution | y = 1.02x + 0.19, r = 0.999 |
| Endogenous Substance Interference | No significant interference was observed at<br>the following concentrations: Hemoglobin(500mg/dL),<br>Cholesterol (1000mg/dL) and Bilirubin (15mg/dL).<br>Interference was observed with Triglycerides(330mg/dL) |
| Sample Types | Serum. |
| Reference Range(Serum Only) | 0.25 - 3.51 mU/L |

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Analytical Sensitivity was determined from 40 replicates of the zero standard (mean =71cpm). Functional Sensitivity was determined from 14 serum pools assayed in 1 run per day for 5 days (mean 0.09mU/L). Total Precision was determined to be 2% to 13% across the range of the assay according to NCCLS guidelines. Samples diluted linearly with a correlation coefficient of 0.999. Serum and Plasma do show some differences, so the intended use will be for Serum only. Samples frozen for 24 hrs gave similar results for hTSH, as samples stored at 4°C for 24hrs. The method comparison was conducted according to the guidelines in NCCLS reference document EP9-A2. Samples from 95 individuals spanning the assay range were evaluated in both kits. The TSH-CTK-3 assay correlated well with the Ventrex hTSH 125 IRMA kit, with a correlation coefficient of 0.99. The serum sample reference interval was established using 100 apparently healthy adults from Western Europe (0.25 – 3.51 mU/L, 95% confidence intervals).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

JUL 1 4 2004

Mr. David M. Ikeda DiaSorin Inc. Manager, Regulatory Affairs & Quality Systems 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285

k041014 Re:

Trade/Device Name: TSH-CTK-3 Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: Class II Product Code: JLW, JIT, JJX Dated: June 24, 2004 Received: June 29, 2004

Dear Mr. Ikeda:

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 Cosnietic 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, 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). 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,

Seain M. Cooper, US, Dvim.

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): _ K041014

Device Name: TSH-CTK-3

Indications For Use:

The DiaSorin TSH-CTK-3 is an immunoradiometric assay for the quantitative determination of thyrotropin (TSH) in human serum. Measurements of TSH levels are used as an aid in the diagnosis of thyroid or pituitary disorders.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

5100 K04/014