(91 days)
Not Found
No
The device description details a standard competitive immunoenzymometric assay, which is a biochemical method and does not involve AI or ML. The document explicitly states "Mentions AI, DNN, or ML: Not Found".
No
This device is for in vitro diagnostic use only, meaning it is used to measure substances from the body rather than directly treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for IN VITRO DIAGNOSTIC USE ONLY" and that "Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen." This directly indicates its role as a diagnostic device.
No
The device is an in vitro diagnostic assay kit, which is a physical product containing reagents and components for performing a laboratory test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: Explicitly states "ST AIA-PACK Testosterone is intended for IN VITRO DIAGNOSTIC USE ONLY".
- Device Description: Describes a laboratory assay performed on human serum, which is a key characteristic of an in vitro diagnostic.
- Input Imaging Modality: States "Not Applicable (In vitro diagnostic assay)".
- Anatomical Site: States "Not Applicable (In vitro diagnostic assay using human serum)".
- Description of the training set, sample size, data source, and annotation protocol: States "Not Applicable (In vitro diagnostic assay)".
- Description of the test set, sample size, data source, and annotation protocol: Describes testing performed on "serum samples".
All of these points clearly indicate that the ST AIA-PACK Testosterone is designed to be used outside of the body to test samples (in this case, human serum) for diagnostic purposes.
N/A
Intended Use / Indications for 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.
or
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.
Product codes (comma separated list FDA assigned to the subject device)
CDZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"For Professional Use" only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Slope: 0.9562
Intercept: -0.7375
Correlation Coefficient: 0.979
Range of Samples: 0.0 - 1107 ng/dL
Number of Samples: 71
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1680 Testosterone test system.
(a)
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.(b)
Classification. Class I.
0
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: (800) 248-6764 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 | |
| of testosterone in | ||
| serum | Quantitative analysis | |
| of testosterone in | ||
| serum, plasma and extracted | ||
| urine | ||
| Methodology | Enzyme Immunoassay | Radioimmunoassay |
| Assay Sample | Human serum | Human serum, plasma |
| 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 | |
| beads | Antibody coated | |
| 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.
2
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
3
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.
4
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: 650/615-4970 Toll Free: 1-600/248-6764 Fax: 650/615-0415
5
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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Page 2 -
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)