# K994419: Fastpack Psa Immunoassay, Fastpack System

- Pathway: 510(k) (Traditional)
- Applicant: Qualisys Diagnostics, Inc.
- Decided: Jun 28, 2000 after 182 days
- Product code: LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K864319 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P910007: Axsym Total Psa & Architect Total Psa, Abbott Laboratories (1991) Summary page 1.
- K864319: TDX (R) II Analyzer, Abbott Laboratories (1986) Summary page 1.

## Recalls of this device
- Nov 8, 2013 · Class II · Z-0547-2014: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.
- Sep 29, 2008 · Not classified · 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.

## Indications for use
The FastPack™ PSA Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum. The FastPack™ PSA Immunoassay is indicated as an aid in the management of patients with prostate cancer. The FastPack™ PSA Immunoassay is designed for use with the FastPack™ Analyzer System.

Source page: https://510kreport.com/device/K994419
Methodology: https://510kreport.com/methodology