# K141689: FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit

- Pathway: 510(k) (Traditional)
- Applicant: Qualigen, Inc.
- Decided: Jan 7, 2015 after 198 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K961828 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051564: Olympus CRP Latex Reagent, OSR6199; Olympus CRP Latex Calibrator Normal Set, ODC0026; Olympus CRP Latex  Calibrator High, Olympus America, Inc. (2005) Summary page 6.
- K050537: Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT, Liquichek Cardiac Markers Plus, Bio-Rad (2005) Summary page 6.
- K041799: Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17, Vitros Chemistry Products FS, Ortho-Clinical Diagnostics, Inc. (2004) Summary page 6.

## Indications for use
FastPack® High Sensitivity C-Reactive Protein Immunoassay is to be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. The FastPack® High Sensitivity C-Reactive Protein Immunoassay is intended for use with the FastPack® Analyzer. Not intended for Point-of-Care use. FastPack® High Sensitivity C-Reactive Protein Calibrators are used for calibrating the quantitative FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer. FastPack® High Sensitivity C-Reactive Protein Controls are used for quality control of the FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer. FastPack® High Sensitivity C-Reactive Protein Verifiers are used in the quantitative verification of calibration and assay range of the quantitative FastPack® High Sensitivity C-Reactive Protein Immunoassay on the FastPack® Analyzer.

Source page: https://510kreport.com/device/K141689
Methodology: https://510kreport.com/methodology