# K042520: Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and Iii

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Nov 30, 2004 after 75 days
- Product code: KLS (Enzyme Immunoassay, Theophylline)
- Device class: 2
- Regulation: 21 CFR 862.3880
- 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 K853872 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853872: Emit Caffeine Assay, Syva Co. (1986) Summary page 3.
- K984288: Vitros Chemistry Products PHBR Slides, Ortho-Clinical Diagnostics, Inc. (1999) Summary page 4.

## Indications for use
1. For in vitro diagnostic use only. VITROS Chemistry Products CAEFN Reagent Kit is used on the VITROS 5,1 FS Chemistry System to quantitatively measure caffeine (CAFFN) concentration in human serum and plasma of subjects undergoing therapy with caffeine, especially for cases of neonatal apnea. 2. For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PIIYT and CAFFN on VITROS Chemistry Systems.

Source page: https://510kreport.com/device/K042520
Methodology: https://510kreport.com/methodology