# K052617: Ferritin Lit Assay, Catalog NO. 7010; Ferritin Calibrator Set, Catalog NO. 7510; Ferritin Controls, Level-L & Level-H,

- Pathway: 510(k) (Traditional)
- Applicant: Good Biotech Corp.
- Decided: Feb 23, 2006 after 153 days
- Product code: DBF (Ferritin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5340
- 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 K935847 (1994). 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)
- K040879: Quantex Ferritin, Instrumentation Laboratory CO (2004) Summary page 1.

## Indications for use
Good Biotech Corp. (GBC) Ferritin LIT Assay system is intended to be used for the quantitative determination of ferritin in human serum by latex particle enhanced immunoturbidimetry (LIT). Measurement of ferritin aids in the diagnosis of diseases affecting iron metabolism. GBC Ferritin Calibrator Set is intended to be used with GBC Ferritin LIT Assay for the quantitative determination of ferritin in serum samples. GBC Ferritin Controls are intended to be used as the assayed quality control material for ferritin analysis. For In P71ro Diagnostic Use. For Prescription Use Only.

Source page: https://510kreport.com/device/K052617
Methodology: https://510kreport.com/methodology