# K062957: Fastpack Total Psa Method Verification Kit

- Pathway: 510(k) (Abbreviated)
- Applicant: Qualigen, Inc.
- Decided: Apr 2, 2007 after 185 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FastPack® Controls: named in the summary without a submission number

## Indications for use
The FastPack®Total PSA Method Verification Kit consists of assayed quality control materials for verification of the calibration and reportable range of the FastPack® Total PSA Immunoassay to meet CLIA requirements.

Source page: https://510kreport.com/device/K062957
Methodology: https://510kreport.com/methodology