FastPack PSA Immunoassay, FastPack System
510(k) K994419
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK994419 | Date28 Jun 2000 | StatusActive |
Recalls
-
- Terminated Z-0547-2014
Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
-
- Terminated Z-0500-2009
The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LTJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.6010
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The FastPack PSA Immunoassay is a two-site chemiluminescence sandwich immunoassay designed for the quantitative measurement of prostate-specific antigen (PSA) in human serum. Classified as a Prostate-Specific Antigen (PSA) device for the management of prostate cancers, it operates within the FastPack Analyzer System to provide diagnostic support in immunology applications.
This device is supplied as a single-use immunoassay kit and requires a compatible analyzer for operation. It is intended for in-vitro use in clinical laboratory settings, adhering to regulatory standards under FDA 510(k) clearance (K994419) and classified under product code LTJ. Sterility and storage conditions are manufacturer-specified, with no explicit MRI safety or reusable components noted in the regulatory data.
Other devices from Qualisys Diagnostics, Inc.
Questions
AI-generated answers, 20 Sep 2026
What clinical specialty does the FastPack PSA Immunoassay support, and how does it function within that specialty?
The FastPack PSA Immunoassay supports the Immunology specialty, specifically for the quantitative measurement of prostate-specific antigen (PSA) in human serum. It operates as a two-site chemiluminescence sandwich immunoassay, providing diagnostic support in prostate cancer management by aiding clinicians in monitoring PSA levels—a key biomarker for detecting, diagnosing, and managing prostate-related conditions.
Is the FastPack PSA Immunoassay designed for single-use or repeated use, and what analyzer does it require?
The FastPack PSA Immunoassay is intended for single-use only and is supplied as a disposable immunoassay kit. It requires a compatible FastPack Analyzer System to function, as it is not standalone and relies on this platform for operation in clinical laboratory settings.
How should the FastPack PSA Immunoassay be stored, and are there any specific sterility or handling requirements?
The FastPack PSA Immunoassay must be stored according to the manufacturer-specified conditions, which are not detailed in the provided data but typically include protection from extreme temperatures, light, and contamination. Since it is a single-use, in-vitro diagnostic device, sterility is implied as a critical requirement for clinical use, and proper handling (e.g., unopened until use) is essential to maintain integrity.
What regulatory pathway was followed for FDA clearance of this device, and what product code does it fall under?
The FastPack PSA Immunoassay received FDA 510(k) clearance (K994419) under the Traditional 510(k) Review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. It is classified under product code LTJ, which corresponds to Prostate-Specific Antigen (PSA) devices for management of prostate cancers, as categorized by the FDA.