# K042838: Vitros Chemistry Products Calibrator Kit 23; Vitros Chemistry Products Palb Performance Verifiers I & II

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Dec 9, 2004 after 56 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K991385 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041799: Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17, Vitros Chemistry Products FS, Ortho-Clinical Diagnostics, Inc. (2004) Summary page 1.

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 23 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of prealbumin. For in vitro diagnostic use only. VITROS Chemistry Products PALB Performance Verifiers are assayed controls used to monitor the performance of PALB Reagent on VITROS 5,1 FS Chemistry Systems.

Source page: https://510kreport.com/device/K042838
Methodology: https://510kreport.com/methodology