# K964282: Tina-Quant Ferritin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jul 30, 1997 after 275 days
- Product code: JMG (Radioimmunoassay (Two-Site Solid Phase), Ferritin)
- 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: 1 generation back to K860137 (1986). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860137: Enzymun-Test Ferritin, Boehringer Mannheim Corp. (1986) Summary page 3.

## Most influential descendants
- K100538: Tina-Quant Ferritin Gen. 4 (2010), 0 descendants of its own

## Indications for use
Immunological in vitro immunoturbidometric test for the quantitative determination of ferritin in human serum and plasma using clinical-chemistry analyzers. A variety of methods are available for determining ferritin, e.g. radio-immunoassay (RIA), enzyme-linked immunosorbent assay (ELISA), fluorescence immunoassay (FIA), luminescence immunoassay (LIA) and nephelometric immunoassay. The assay is unaffected by icterus (bilirubin up to 60 mg/dl), hemolysis (Hb < 0.5 g/dl), lipemia (triglycerides < 1500 mg/dl) and rheumatoid factor (< 100 IU/ml). (Criterion: recovery within ± 10% of initial value.) For diagnostic purposes, the ferritin findings should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

Source page: https://510kreport.com/device/K964282
Methodology: https://510kreport.com/methodology