# K964721: Vitros Immunodiagnostics Products Total T4 Reagent Pack (Gem.1005) Total T4 Calibrators (Gem.C005)

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
- Decided: Dec 18, 1996 after 23 days
- Product code: KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1700
- Recalls of this device: 2 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jun 2, 2016 · Class II · Z-2302-2016: Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack storage limit of <= 8 we
- Mar 15, 2005 · Not classified · Z-0913-05: Potential for positively biased results in QC and patient samples.

Source page: https://510kreport.com/device/K964721
Methodology: https://510kreport.com/methodology