# K020454: Chemistry Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Jas Diagnostics, Inc.
- Decided: Apr 8, 2002 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
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
Intended for the calibration of multiple in vitro quantitative chemistry assays on automated chemistry analyzers, such as the Roche Cobas Mira Chemistry Analyzers. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Source page: https://510kreport.com/device/K020454
Methodology: https://510kreport.com/methodology