Axsym Anti-HCV (LN 5C36)
by Abbott Laboratories PMA
Withdrawn
PMA P970027
Overview
The Axsym Anti-HCV (LN 5C36) is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of anti-hepatitis C virus recombinant proteins in human serum or plasma. It falls under the device type ‘Assay, enzyme linked immunosorbent, hepatitis C virus’ and is intended for microbiological testing.
This in vitro diagnostic device is supplied as a single-use reagent kit for laboratory use, requiring human serum or plasma collected in potassium EDTA, sodium EDTA, sodium heparin, lithium heparin, sodium citrate, or potassium oxalate. It is approved under FDA PMA (P970027) and classified as a Class II device under regulation 866.3169, with no noted MRI compatibility or sterility requirements beyond standard laboratory handling.
Regulatory status
Withdrawn since 5 Feb 2004. The authorization below is no longer in force.
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPWD | NumberP970027 | Date5 Feb 2004 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Withdrawn
Recalls
-
- Terminated Z-1034-2007
Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.
Specification
- Trade Name
- Abbott Axsym Antibody to Hcv
- Generic Name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- PMA Number
- FDA Product Code
- MZO
- Regulation
- 21 CFR Part 866.3169
- Advisory Committee
- Microbiology
- FDA Decision
- APWD Approval withdrawn
Other devices from Abbott Laboratories
Questions
What is the Axsym Anti-HCV (LN 5C36) used for in clinical testing?
The Axsym Anti-HCV (LN 5C36) is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of anti-hepatitis C virus (HCV) recombinant proteins in human serum or plasma. It helps identify antibodies that indicate prior exposure to HCV, aiding in microbiological testing for hepatitis C infection screening.
What types of blood samples can be tested with this device?
This device requires human serum or plasma collected using specific anticoagulants, including potassium EDTA, sodium EDTA, sodium heparin, lithium heparin, sodium citrate, or potassium oxalate. The sample type must align with these listed anticoagulants for accurate testing.
Is the Axsym Anti-HCV (LN 5C36) intended for single-use or reusable applications?
The Axsym Anti-HCV (LN 5C36) is supplied as a single-use reagent kit for laboratory use. Each kit is designed for one test run, ensuring consistency and preventing cross-contamination between samples.
What regulatory pathway was followed for this device’s approval?
The Axsym Anti-HCV (LN 5C36) was approved under the FDA Premarket Approval (PMA) pathway, specifically under PMA number P970027. It is classified as a Class II device under regulation 866.3169, indicating it undergoes rigorous review for safety and effectiveness before market authorization.
Are there any special storage requirements for this device beyond standard laboratory conditions?
The device data does not specify unique sterility or storage requirements beyond standard laboratory handling. Since it is a single-use reagent kit, it should be stored according to manufacturer guidelines (e.g., refrigeration if applicable) to maintain integrity until use, though no explicit conditions like temperature or humidity are mentioned.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA PMA P970027