(85 days)
Not Found
No
The device description details a standard immunoradiometric assay based on chemical reactions and radioactivity measurement, with no mention of AI or ML techniques for data analysis or interpretation.
No
This device is for the quantitative determination of thyrotropin (TSH) in human serum, used as an aid in diagnosis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements of TSH levels are used as an aid in the diagnosis of thyroid or pituitary disorders."
No
The device description clearly outlines a laboratory assay kit involving physical components like tubes, antibodies, and radioactive isotopes, requiring physical manipulation and measurement. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of thyrotropin (TSH) in human serum." This is a test performed on a biological sample (serum) outside of the body.
- Purpose: The measurements are used "as an aid in the diagnosis of thyroid or pituitary disorders." This indicates the test is used for medical purposes to provide information about a patient's health status.
- Device Description: The description details a laboratory assay (immunoradiometric assay) that uses reagents and a measurement system to analyze the sample. This is characteristic of an in vitro diagnostic device.
Therefore, based on the provided information, the DiaSorin TSH-CTK-3 fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JLW, JIT, JJX
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.
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
Not Found
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)
- 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 the following concentrations: Hemoglobin(500mg/dL), Cholesterol (1000mg/dL) and Bilirubin (15mg/dL). Interference was observed with Triglycerides(330mg/dL)
- Sample Types: Serum.
- Reference Range(Serum Only): 0.25 - 3.51 mU/L
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- 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
- Correlation coefficient for method comparison: 0.99
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.
Ventrex hTSH 125I IRMA (K920856)
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
§ 862.1690 Thyroid stimulating hormone test system.
(a)
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.(b)
Classification. Class II.
0
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 |
| 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.
1
| TECHNOLOGICAL COMPARISON TO PREDICATE: | ||
|---|---|---|
| ---------------------------------------- | -- | -- |
| Feature | Ventrex hTSH 125I IRMA (K920856) | TSH-CTK-3 |
|---|---|---|
| Analyte | Thyroid Stimulating Hormone(hTSH) | Thyroid Stimulating Hormone (hTSH) |
| Intended | ||
| Use | FOR in vitro DIAGNOSTIC USE. | |
| The Ventrex hTSH 125I IRMA kit is to be | ||
| used for the quantitative | ||
| determination of TSH (thyroid stimulating | ||
| hormone) concentration | ||
| in serum. | FOR in vitro DIAGNOSTIC USE. | |
| The DiaSorin TSH-CTK-3 is an immuno- | ||
| radiometric assay for the determination of | ||
| thyrotropin(TSH) in human serum. | ||
| Measurements of TSH are used as an aid in | ||
| the diagnosis of thyroid and pituitary | ||
| disorders. | ||
| Assay | ||
| Type | IRMA | IRMA |
| Coated | Mouse Monoclonal Anti-hTSH | Mouse Monoclonal Anti-Thyrotropin |
| antibody | ||
| Tube | ||
| Tracer | 125I Goat Anti-hTSH | 125I Mouse Monoclonal Anti-Thyrotropin |
| antibody | ||
| Standards | Eight levels, porcine serum based with | |
| nominal concentrations ranging from | ||
| 0.125-100mIU/L. Standardized | ||
| against the World Health Organization | ||
| (WHO) Reference Program 80/558. | Seven levels, human serum based with | |
| nominal concentrations ranging from | ||
| 0.02-0.92mU/L. Standardized against | ||
| the World Health Organization (WHO) | ||
| Reference Program 80/558. | ||
| Kit | ||
| 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 |
| the following concentrations: Hemoglobin(500mg/dL), | |
| Cholesterol (1000mg/dL) and Bilirubin (15mg/dL). | |
| Interference was observed with Triglycerides(330mg/dL) | |
| Sample Types | Serum. |
| Reference Range(Serum Only) | 0.25 - 3.51 mU/L |
2
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).
3
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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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
5
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