# K982649: Vitros Chemistry Products TDM Performance Verifiers I, II, and Iii

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Aug 12, 1998 after 13 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- Recalls of this device: none
- 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.

## Indications for use
For in vitro diagnostic use only. VITROS TDM Performance Verifiers are designed for use in assessing bias (mean) and impersion (standard deviation) for each reagent lot. Published values are derived from interlaboratory performance data. This fluid should be assayed in the same manner as a patient sample. The reported values can then be compared with those given on the assay sheet.

Source page: https://510kreport.com/device/K982649
Methodology: https://510kreport.com/methodology