# K984288: Vitros Chemistry Products PHBR Slides

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Jan 26, 1999 after 56 days
- Product code: DLZ (Enzyme Immunoassay, Phenobarbital)
- Device class: 2
- Regulation: 21 CFR 862.3660
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K042476: Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12; Vitros Chemistry Products TDM Perfos (2004), 3 descendants of its own
- K043384: Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers I, II and Iii (2005), 0 descendants of its own
- K043386: Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers I, II and Iii (2005), 0 descendants of its own
- K042479: Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products Calibrator Kits 11, 13 & 14; Vitros Che (2005), 0 descendants of its own
- K042520: Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and Iii (2004), 0 descendants of its own

## Recalls of this device
- Jun 12, 2013 · Class II · Z-0319-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
- Mar 14, 2013 · Class II · Z-1152-2013: Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chem
- Jun 23, 2011 · Not classified · Z-1117-2012: Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in control fluid values when using various lots of VITROS Chemistry Products PHBR Slides 

## Indications for use
For in vitro diagnostic use only. VITROS PHBR slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma.

Source page: https://510kreport.com/device/K984288
Methodology: https://510kreport.com/methodology