# K123725: Fastpack Control Kit

- Pathway: 510(k) (Traditional)
- Applicant: Qualigen, Inc.
- Decided: Mar 8, 2013 after 94 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- 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
Longest line of descent: 2 generations back to K942566 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960824: Immunology Control, Medical Analysis Systems, Inc. (1996) Summary page 2.
- K003095: Fastpack Control, Qualigen, Inc. (2000) Summary page 2.
- K052301: Fastpack TSH Immunoassay, Qualigen, Inc. (2006) Summary page 2.

## Indications for use
The FastPack® Control Kit is an assayed quality control for the verification of the accuracy and precision of the FastPack® and FastPack® IP Systems when used for the quantitative determination of the analytes listed in the package insert. The following analytes are included in the package insert: - Free Thyroxine (FT4) - Human Chorionic Gonadotropin (hCG) - Testosterone - Total Prostate Specific Antigen (tPSA) - Thyroid Stimulating Hormone (TSH)

Source page: https://510kreport.com/device/K123725
Methodology: https://510kreport.com/methodology