(214 days)
Not Found
No
The device description details a standard radioimmunoassay procedure, which is a chemical and physical process, not involving computational algorithms like AI or ML. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
This device is an in vitro diagnostic (IVD) assay used for the quantitative measurement of free testosterone in human serum, which aids in diagnosis. It does not provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This assay is intended for in vitro diagnostic use," and describes its use in the "diagnosis and treatment of disorders."
No
The device description clearly outlines a radioimmunoassay kit containing physical components like antibody-coated tubes, labeled tracer, calibrators, and controls. This indicates a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "This assay is intended for in vitro diagnostic use."
- Nature of the Test: The device performs a radioimmunoassay on human serum to measure free testosterone. This is a laboratory test conducted outside of the body to diagnose or monitor medical conditions.
- Intended Use: The intended use is for the diagnosis and treatment of various disorders related to male sex hormones, which is a diagnostic purpose.
- Kit Content: The kit contains reagents and components designed for performing a laboratory test on biological samples.
- Intended User / Care Setting: The mention of "in vitro diagnostic use" further reinforces that it is intended for use in a laboratory or clinical setting for diagnostic purposes.
N/A
Intended Use / Indications for Use
Radioimmunoassay for the quantitative measurement of free testosterone in human serum. This assay is intended for in vitro diagnostic use.
Free testosterone test is 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 female's hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
Product codes
CDZ
Device Description
The ACTIVE® Free Testosterone RIA kit contains:
- Free Testosterone Antibody-Coated Tubes: 2 x 50 tubes (ready-to-use) made of plastic tubes with rabbit anti-testosterone immunoglobulin immobilized to the inside wall.
- 125I-labeled Testosterone Analog Tracer (YELLOW): one 22 mL vial (ready-to-use) containing 185 kBq, (
§ 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
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December 20, 2019
Immunotech s.r.o. Vit Oburka Ouality and Regulatory Affairs Manager Radiova 1 Prague, 102 27 Cz
Re: K191350
Trade/Device Name: ACTIVE® Free Testosterone RIA Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone Test System Regulatory Class: Class I, reserved Product Code: CDZ Dated: November 25, 2019 Received: November 25, 2019
Dear Vit Oburka:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191350
Device Name ACTIVE® Free Testosterone RIA
Indications for Use (Describe)
Radioimmunoassay for the quantitative measurement of free testosterone in human serum. This assay is intended for in vitro diagnostic use.
Free testosterone test is 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 female's hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510k Summary ACTIVE® Free Testosterone RIA
1. Submitted by:
Vit Oburka Quality and Regulatory Affairs Manager IMMUNOTECH s.r.o. Radiova 1, 102 27 Prague Czech Republic Tel.: +420 272 017 368 Email: voburka@beckman.com
2. Date of preparation:
October 19, 2019
3. Device Identification
| Proprietary Name: | ACTIVE® Free Testosterone RIA |
|---|---|
| Common Name: | Free Testosterone |
| Classification: | Class I, reserved |
| Product Codes: | CDZ |
| Regulation Number: | 21 CFR 862.1680 |
4. Predicate Device
| Proposed Device | Predicate | Manufacturer | License
Number |
|----------------------------------|----------------------------------|-------------------|-------------------|
| ACTIVE® Free
Testosterone RIA | ACTIVE® Free
Testosterone RIA | IMMUNOTECH s.r.o. | K952281 |
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Description 5.
Kit Content:
Free Testosterone Antibody-Coated Tubes: 2 x 50 tubes (ready-to-use)
Plastic tubes with rabbit anti-testosterone immunoglobulin immobilized to the inside wall of each tube.
125|-labeled Testosterone Analog Tracer (YELLOW): one 22 mL vial (ready-to-use)
At the time of manufacture, the vial contains 185 kBq, (Sensitivity
Limit of Blank (LoB) of 0.05 pg/mL.
Limit of detection (LoD): 0.13 pg/mL
Limit of Quantitation (LoQ): 0.37 pg/mL
Specificity
The antibody used in the immunoassay is highly specific for free testosterone.
Low cross reactivities were obtained against several related molecules. | | | | | | |
IMMUNOTECH s.r.o. Radiová 1, 102 27 Praha 10 tel.: +420 272 017 011 tel.: +420 272 017 200 E-mail: office.iot@beckman.com www.immunotech.cz
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Image /page/8/Picture/0 description: The image shows the Immunotech logo. The logo consists of a blue abstract shape on the left and the word "IMMUNOTECH" in bold blue letters on the right. Below the word "IMMUNOTECH" is the text "A BECKMAN COULTER COMPANY" in smaller letters.
tel.: +420 272 017 011
tel.: +420 272 017 200
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Image /page/9/Picture/0 description: The image shows the Immunotech logo. The logo consists of a blue abstract shape on the left and the word "IMMUNOTECH" in bold blue letters on the right. Below the word "IMMUNOTECH" is the text "A BECKMAN COULTER COMPANY" in smaller black letters. The logo is clean and professional, and the colors are consistent.
| | Precision
Repeatability and within-laboratory precision
For repeatability the coefficients of variation were
found below or equal to 13.2% for serum samples. For within laboratory
precision the coefficients of variation were found below or equal to 19.3% for serum samples. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Measurement range | Measurement range (from LoQ to the highest calibrator): 0.37 pg/mL to approximately 100 pg/mL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Interference
New data CLSI
guidelines | Substance Interferent concentration Hemoglobin 641 µg/mL Conjugated bilirubin 199 µg/mL Unconjugated bilirubin 92.7 µg/mL Biotin 1,020 ng/mL Ascorbic acid 40.5 µg/mL Ibuprofen 122 µg/mL Cholesterol 0.75 mg/mL Heparin 7,248 ng/mL Prednisone 384 ng/mL Prednisolone 1,294 ng/mL Protein (γ-globulin) 49.5 mg/mL Rheumatoid factor 3.45 IU/mL Acetylsalicylic acid 24.2 µg/mL Triglycerides 3.35 mg/mL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Linearity | Criterion Result Linear throughout the measuring range of the kit (from LoQ to the highest calibrator) Linear within 0.30 – 114.11 pg/mL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cross-reactivity
Different methodology
of cross-reactivity
testing | Pooled normal serum Compound Cross-reactant conc. (ng/mL) Cross reactivity (%) 19-Nortestosterone 8.62 0.068 11-Ketotestosterone 102 0.020 11beta-Hydroxytestosterone 14.1 0.029 Androstenediol 14.8 0.010 Methyltestosterone 96.5 0.017 Androstenedione 92.4 0.006 Norethindrone 1,056 0.001 5α-Androstane-3α,17β-diol 1,076 0.002 5β-Androstane-3,17-dione 1011 ND 5α-Androstane-3,17-dione 846 0.001 Danazol 921 0.001 Estradiol 946 0.001 Progesterone 956 0.001 Deoxycorticosterone 911 ND | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
tel.: +420 272 017 011
tel.: +420 272 017 200
E-mail: office.iot@beckman.com
www.immunotech.cz
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Image /page/10/Picture/0 description: The image shows the logo for Immunotech, a Beckman Coulter company. The logo features a blue abstract symbol on the left, followed by the word "IMMUNOTECH" in bold, blue letters. Below the company name, the text "A BECKMAN COULTER COMPANY" is written in a smaller, sans-serif font.
| Androsterone | 1.002 | ND |
|---|---|---|
| Epiandosterone | 943 | ND |
| DHEA | 896 | ND |
| Estriol | 882 | ND |
| Estrone | 913 | ND |
| Corticosterone | 951 | ND |
| Cortisol | 857 | ND |
| Pregnenolone | 944 | ND |
| DHT | 168 | 0.020 |
| Androstanediol Glucuronide | 1,031 | ND |
| DHEA-S | 922 | ND |
| 5α -Androstan-3β, 17β diol | 98.0 | 0.005 |
| rhSHBG | 10,407 | ND |
| ND = Non-Detectable ( |