ST AIA-PACK TESTOSTERONE ASSAY

K023091 · Tosoh Medics, Inc. · CDZ · Dec 17, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023091
• Device Name: ST AIA-PACK TESTOSTERONE ASSAY
• Applicant: Tosoh Medics, Inc.
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Dec 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1680
• Device Class: Class 1

Intended Use

ST AIA-PACK Testosterone is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific TOSOH AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. This device is intended "For Professional Use" only.

Device Story

ST AIA-PACK Testosterone is a competitive immunoenzymometric assay for use on TOSOH AIA System analyzers. The device utilizes monoclonal mouse antibodies immobilized on magnetic beads. During operation, testosterone in the patient serum sample competes with enzyme-labeled testosterone for binding sites on the magnetic beads. After washing to remove unbound labeled testosterone, the beads are incubated with a fluorogenic substrate (4-methylumbelliferyl phosphate). The amount of enzyme-labeled testosterone bound is inversely proportional to the testosterone concentration in the sample. The system constructs a standard curve to calculate unknown sample concentrations. The device is intended for professional use in clinical laboratories to assist healthcare providers in diagnosing and managing androgen-related conditions. Results are provided to clinicians to inform clinical decision-making regarding patient hormonal status.

Clinical Evidence

Clinical evidence consists of a comparative analysis study using 71 human serum samples. The ST AIA-PACK Testosterone was compared against the predicate DPC Coat-A-Count assay. Results showed a correlation coefficient of 0.979, a slope of 0.9562, and an intercept of -0.7375 over a range of 0.0 to 1107 ng/dL. Precision studies reported intra-run %CVs of ≤5.3% and inter-run %CVs of ≤5.99%. Recovery studies on spiked and diluted samples showed recoveries between 85.5% and 113.5%.

Technological Characteristics

Competitive immunoenzymometric assay. Reagents consist of monoclonal (mouse) antibody-coated magnetic beads and alkaline phosphatase-labeled testosterone. Detection uses fluorogenic substrate 4-methylumbelliferyl phosphate (4MUP). Assay range: 10-2200 ng/dL. Designed for use on automated TOSOH AIA System analyzers.

Indications for Use

Indicated for the quantitative measurement of total testosterone in human serum to aid in the diagnosis and management of conditions involving androgen excess or deficiency in professional clinical settings.

Regulatory Classification

Identification

A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Predicate Devices

• Coat-A-Count Total Testosterone (K831342)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Tosoh Medics, Inc. The logo consists of a stylized four-leaf clover shape with a square in the center, followed by the text "TOSOH MEDICS, INC." to the right. Below the clover shape, the text "TOSOH" is printed in a smaller font size.

DEC 1 7 2002

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

| The assigned 510(k) number is: | K023091 |
|--------------------------------|---------|
|--------------------------------|---------|

Tosoh Medics, Inc. 347 Oyster Point Blvd., Suite 201 South San Francisco. CA 94080 Phone: [phone] Fax:

Contact Person:

Lois Nakayama Manager, Quality Assurance

Date of Summary Preparation:

Device Name:

Classification Name:

Predicate Device:

September 16, 2002

ST AIA-PACK Testosterone

Testosterone test system

Coat-A-Count Total Testosterone Diagnostic Products Corporation Los Angeles, CA U.S.A. K831342

### Device Description:

The ST AIA-PACK Testosterone is a competitive immunoenzymometric assay which is performed entirely in the AIA-PACK. Testosterone present in the test sample competes with enzyme-labeled testosterone for a limited number of binding sites on a testosterone-specific monoclonal antibody, immobilized on a magnetic solid phase. The magnetic beads are washed to remove urbound enzyme-labeled testosterone and are then incubated with a fluorogenic substrate, 4methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled testosterone that binds to the beads is inversely proportional to the testosterone concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

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### Statement of Intended Use:

ST AIA-PACK Testosterone is designed for in vitro diagnostic use only for the quantitative measurement of Testosterone (LH) in human serum on specific TOSOH AIA System analyzers.

# Substantial Equivalence:

### Comparison Data:

The ST AIA-PACK Testosterone Assay is substantially equivalent to the previously cleared Diagnostic Product Corporation (DPC) Coat: A Count Total Testosterone assay since both assays are equivalent in the analyte that is detected, their intended uses, and performance characteristics.

See Table 1 for a comparison of the salient characteristics of the ST AIA-PACK Testosterone to the currently marketed DPC Coat A Count Total Testosterone reagents.

| | ST AIA-PACK Testosterone | DPC Coat-A-Count |
|------------------|------------------------------------------------------|-------------------------------------------------------------------------------------|
| Intended Use | Quantitative analysis<br>of testosterone in<br>serum | Quantitative analysis<br>of testosterone in<br>serum, plasma and extracted<br>urine |
| Methodology | Enzyme Immunoassay | Radioimmunoassay |
| Assay Sample | Human serum | Human serum, plasma<br>or urine |
| Analyte Detected | Total Testosterone | Total Testosterone |
| Antibody | Monoclonal (mouse) | Polyclonal |
| Assay Range | 10 - 2200 ng/dL | 4 - 1600 ng/dL |
| Reagent Form | Antibody-coated magnetic<br>beads | Antibody coated<br>polypropylene tubes |
| Antibody label | Alkaline Phosphatase | 125Iodine |

## Table 1 Comparison of Characteristics: ST AIA-PACK Testosterone vs. DPC Coat A Count

Image /page/1/Picture/8 description: The image shows the logo for Tosoh Corporation. The logo consists of a stylized black shape resembling a plus sign with rounded edges and a white square in the center. Below the symbol, the word "TOSOH" is printed in a bold, sans-serif font.

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### Comparative Analysis

Comparative analysis studies were performed with 71 serum samples by assaying the samples with the ST AIA-PACK Testosterone (y) and the DPC COAT-A-COUNT Total Testosterone Cat. No. TKTT1 (x) assays. A summary of the comparative analysis statistics is presented in Table 2 and a graphical representation of the data is shown in Figure 1.

#### Table 2 Comparative Analysis: ST AIA-PACK Testosterone vs. DPC Coat A Count

| Slope: | 0.9562 |
|--------------------------|------------------|
| Intercept: | -0.7375 |
| Correlation Coefficient: | 0.979 |
| Range of Samples: | 0.0 - 1107 ng/dL |
| Number of Samples: | 71 |

Image /page/2/Figure/4 description: The image shows the title of a figure, which is "Figure 1". The figure is a comparative analysis. The analysis compares ST AIA-PACK Testosterone vs. DPC Coat A Count.

Image /page/2/Figure/5 description: This image is a scatter plot comparing two variables, DCP on the x-axis and AIA#2472 on the y-axis. The data points show a strong positive correlation, which is confirmed by the linear regression equation displayed on the plot, y = 0.9562x - 0.7375. The R-squared value is 0.979, indicating that the linear model explains 97.9% of the variance in the data.

TOSOH

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Precision studies demonstrated intra-run precision %CVs of 5.3% or less and inter-run precision %CVs of 5.99 or less. Recovery studies performed on spiked and diluted samples generated recoveries of 85.5% to 113.4% and 91.5% to 113.5%, respectively.

# Conclusion:

Considering the excellent correlation between the Tosoh ST AIA-PACK Testosterone Enzyme Immunoassay and the DPC Coat A Count Total Testosterone assay, it can be concluded that the ST AIA-PACK Testosterone is substantially equivalent to the Coat A Count assay, which has been 510(k) cleared. Based on the establishment of substantial equivalence, the safety and effectiveness of the ST Tosoh AIA-PACK Testosterone assay is confirmed.

Image /page/3/Picture/3 description: The image shows the logo for TOSOH. The logo consists of a stylized four-leaf clover shape in black, with a white square in the center. Below the shape, the word "TOSOH" is printed in a simple, sans-serif font.

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Image /page/4/Picture/0 description: The image shows the logo for Tosoh Medics, Inc. The logo consists of a black four-leaf clover shape with a white square in the center, followed by the text "TOSOH MEDICS, INC." The word "TOSOH" is also printed below the clover shape.

# PREMARKET NOTIFICATION

# INDICATION FOR USE STATEMENT

# ST AIA-PACK Testosterone Assay

ST AIA-PACK Testosterone is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific TOSOH AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.

This device is intended "For Professional Use" only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

347 Oyster Point Blvd., Suite 201, South San Francisco, California 94060 Tel: [phone] Toll Free: 1-600/248-6764 Fax: [phone]

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/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" arranged around the perimeter. Inside the circle is a stylized design featuring three curved lines that resemble a human figure or a symbol representing health and well-being.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lois Nakayama Manager, Quality Assurance Tosoh Medics, Inc. 347 Oyster Point Blvd, Suite 201 South San Francisco, CA 94080

Re:

Trade/Device Name: ST AIA PACK Testosterone Assay Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone test system Regulatory Class: Class II Product Code: CDZ Dated: December 4, 2002 Received: December 5. 2002

Dear Ms. Nakayama:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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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" (21CFR 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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Image /page/7/Picture/0 description: The image shows the logo for Tosoh Medics, Inc. The logo consists of a stylized cross shape with a square in the center, followed by the text "TOSOH MEDICS, INC." The word "TOSOH" is also printed below the cross shape.

# PREMARKET NOTIFICATION

# INDICATION FOR USE STATEMENT

# ST AIA-PACK Testosterone Assa

ST AIA-PACK Testosterone is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific TOSOH AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.

This device is intended "For Professional Use" only -

ly
(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number ,

(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-CounterUse

(Optional Format 1-2-96)