Transtat-Cmv(Tm)
510(k) K903308
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903308 | Date4 Dec 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LFX
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3510
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The TransStat-CMV is an Enzyme Linked Immunoabsorbent Assay (ELISA) device designed for the qualitative detection of IgG antibodies to rubella virus in human serum or plasma. It is classified under FDA regulation 866.3510 and falls within the microbiology specialty category, specifically for serological testing.
This device is intended for in vitro diagnostic use in clinical microbiology laboratories. Supplied as a single-use reagent kit, it requires no sterilization beyond manufacturer-provided packaging. The TransStat-CMV is regulated under FDA 510(k) clearance (K903308) with a decision of Substantially Equivalent (SESE) and is classified as a Class II medical device. Storage and handling follow standard in vitro diagnostic assay protocols as specified in the accompanying instructions.
Questions
AI-generated answers, 1 Oct 2026
What is the TransStat-CMV used for?
The TransStat-CMV is an Enzyme Linked Immunoabsorbent Assay (ELISA) device designed specifically for the qualitative detection of IgG antibodies to rubella virus in human serum or plasma. It helps clinicians determine whether a patient has been previously exposed to the rubella virus, which is critical for diagnosing past infection and assessing immunity. This is particularly useful in clinical microbiology laboratories for serological testing.
How is the TransStat-CMV supplied, and does it require sterilization?
The TransStat-CMV is supplied as a single-use reagent kit. According to the manufacturer’s specifications, no additional sterilization is required beyond the sterility maintained in the original packaging. This ensures ease of use and compliance with standard in vitro diagnostic assay protocols.
Is the TransStat-CMV intended for single-use or reuse?
The TransStat-CMV is explicitly designed for single-use only. This is a standard practice for ELISA kits to prevent cross-contamination and ensure accurate, reliable results. Each kit is meant to be used once per test, adhering to best practices for in vitro diagnostic assays.
What regulatory pathway does the TransStat-CMV follow?
The TransStat-CMV is regulated under the FDA’s 510(k) clearance pathway, specifically with clearance number K903308. It was determined to be Substantially Equivalent (SESE) to a predicate device and is classified as a Class II medical device. This classification reflects its role as an in vitro diagnostic device for serological testing.
How should the TransStat-CMV be stored, and what are the handling guidelines?
The TransStat-CMV follows standard storage and handling protocols for in vitro diagnostic assays. The manufacturer’s instructions provide detailed guidelines, but generally, it should be stored in a clean, dry environment protected from extreme temperatures and direct light. Proper storage ensures the integrity of the reagents and the accuracy of test results. Always refer to the accompanying instructions for specific storage conditions.