Toxoplasma Gondii-CF Antigen and Control Antigen
by Microbix Biosystems Inc. 510(k)
Active
510(k) K894261
Overview
This device is a Toxoplasma Gondii-CF Antigen and Control Antigen, classified under Antigens (FDA Product Code: GMN) and regulated under 21 CFR 866.3780. It is designed for use in microbiological assays, specifically as a reagent for detecting antibodies against Toxoplasma gondii in diagnostic testing. The antigen preparation is intended for immunoassay development, including ELISA and automated platforms, to support serological testing for toxoplasmosis.
The Toxoplasma Gondii-CF Antigen and Control Antigen is supplied as a reagent for laboratory use in infectious disease diagnostics. It holds FDA 510(k) clearance (K894261) and is classified as a Class II medical device, determined to be substantially equivalent to a predicate device. The product is intended for research and manufacturing purposes in immunoassay development, with no indication of sterility or single-use/reusable status specified in regulatory filings. Compliance with 21 CFR 866.3780 ensures adherence to microbiological reagent standards.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK894261 | Date16 Oct 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GMN
- FDA applicant
- Microbix Biosystems, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3780
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
Microbix has been the commercial leader in producing native ToRCH antigen products for over 20 years. View our full catalogue of antigen products.
Manufacturer's product page: Antigens
Other devices from Microbix Biosystems Inc.
Questions
What is the Toxoplasma Gondii-CF Antigen used for in diagnostic testing?
The Toxoplasma Gondii-CF Antigen is designed as a reagent for developing immunoassays, such as ELISA and automated platforms, to detect antibodies against *Toxoplasma gondii*. It aids in serological testing for toxoplasmosis by providing the specific antigen needed for accurate antibody detection in microbiological assays.
How is the Toxoplasma Gondii-CF Antigen supplied, and what are its intended uses?
This antigen is supplied as a laboratory reagent for research and manufacturing purposes in immunoassay development. It is not intended for direct patient testing but serves as a critical component in creating diagnostic assays. The product is classified under Antigens (FDA Product Code: GMN) and adheres to microbiological reagent standards outlined in 21 CFR 866.3780.
Is the Toxoplasma Gondii-CF Antigen sterile, and can it be reused?
The regulatory filings for this device do not specify sterility or single-use/reusable status, meaning it is not explicitly labeled as sterile or intended for reuse. As a reagent, it is typically used in controlled laboratory settings where contamination risks are managed through standard microbiological practices.
What regulatory approval does the Toxoplasma Gondii-CF Antigen hold, and how was it classified?
The Toxoplasma Gondii-CF Antigen holds FDA 510(k) clearance (K894261) and is classified as a Class II medical device. It was determined to be substantially equivalent to a predicate device through a traditional review process, ensuring compliance with microbiological reagent standards for immunoassay development.
What types of assays can this antigen support, and where is it manufactured?
This antigen supports immunoassay development, including ELISA and automated platforms, for detecting *Toxoplasma gondii* antibodies. It is manufactured by Microbix Biosystems Inc., located at Darts Mill, Flemington, NJ 08822, USA. The product is intended for use in microbiology labs specializing in infectious disease diagnostics.