# K980283: Vitros Chemistry Products CRBM Slides

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
- Decided: Feb 25, 1998 after 30 days
- Product code: KLT (Enzyme Immunoassay, Carbamazepine)
- Device class: 2
- Regulation: 21 CFR 862.3645
- 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.
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’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Mar 5, 2014 · Class II · Z-1470-2014: The firm identified a potential for biased carbamazepine (CRBM) results to be generated when using VITROS CRBM Slides, Lot 3920-0080-8403.
- Jun 12, 2013 · Class II · Z-0307-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. VITROS CRBM Slides quantitatively measure carbamazepine (
- May 26, 2005 · Not classified · Z-1016-05: Falsely elevated Carbamazepine results.

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

Source page: https://510kreport.com/device/K980283
Methodology: https://510kreport.com/methodology