# K060940: Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT Performance Verifier I, II, and Iii

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Apr 24, 2006 after 18 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- 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: 4 generations back to K904768 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052819: Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and Iii, Ortho-Clinical Diagnostics, Inc. (2005) Summary page 1.

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of proteins in body fluids. For in vitro diagnostic use only. VITROS Chemistry Products AAT/HPT Performance Verifiers are assayed controls used to monitor the performance of protein measurements in body fluids on VITROS 5,1 FS Chemistry Systems.

Source page: https://510kreport.com/device/K060940
Methodology: https://510kreport.com/methodology