# K970281: Vitros Immunodiagnostic Products Prolactin Reagent Pack/Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
- Decided: Feb 25, 1997 after 32 days
- Product code: CFT (Radioimmunoassay, Prolactin (Lactogen))
- Device class: 1
- Regulation: 21 CFR 862.1625
- 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
- Mar 25, 2022 · Class II · Z-1114-2022: Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and 
- Jul 12, 2018 · Class II · Z-0060-2019: The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Inst

Source page: https://510kreport.com/device/K970281
Methodology: https://510kreport.com/methodology