IMX Rubella IgG
by Abbott Laboratories 510(k)
Active
510(k) K951541
Overview
The IMX Rubella IgG is an Enzyme-Linked Immunosorbent Assay (ELISA) device designed for the qualitative detection of IgG antibodies to the Rubella virus in human serum or plasma. It functions as an immunoassay to identify past or current exposure to Rubella by measuring specific antibody levels, aiding in diagnostic evaluation for infection or immunity status.
This device is supplied as a single-use, in vitro diagnostic reagent and is classified under FDA 510(k) clearance (K951541) as a Class II Microbiology product (product code: LFX). It is intended for use in clinical laboratories and requires adherence to standard laboratory protocols. No regulatory status beyond the stated FDA clearance is implied.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK951541 | Date16 Jul 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
Other devices from Abbott Laboratories
Questions
What clinical question does the IMX Rubella IgG test help answer in patient care?
The IMX Rubella IgG test detects IgG antibodies to the Rubella virus, helping clinicians determine whether a patient has been previously exposed to Rubella (indicating immunity) or if they may have a current or past infection. This aids in diagnostic evaluation for immunity status, particularly important for pregnant women or individuals planning pregnancy, as Rubella can cause congenital abnormalities if contracted during early pregnancy.
Is the IMX Rubella IgG test single-use, and if so, how should it be stored?
Yes, the IMX Rubella IgG is designed for single-use only, as specified in the device description. Since it is an in vitro diagnostic reagent, it should be stored according to the manufacturer’s instructions (not provided here) to maintain its integrity. Typically, such assays require refrigeration (2–8°C) and protection from light until use, but always refer to the included package insert for precise storage guidelines.
What type of sample can be tested with the IMX Rubella IgG, and is there any preparation required?
The IMX Rubella IgG is intended for use with human serum or plasma samples. No additional sample preparation is mentioned in the device data, but standard laboratory protocols for handling and processing these specimens should be followed to ensure accurate results. Always consult the accompanying instructions for use for any specific handling or dilution requirements.
How is the IMX Rubella IgG test classified by the FDA, and what does this mean for its use?
The IMX Rubella IgG is classified as a Class II Microbiology product under FDA product code LFX and has received 510(k) clearance (K951541). This classification means it is subject to general controls and special controls to ensure its safety and effectiveness, but it does not require premarket approval. It is intended for use in clinical laboratories and must comply with standard laboratory practices and protocols.