# K022027: Calibrating Material, Buffers, Standard

- Pathway: 510(k) (Traditional)
- Applicant: Mission Diagnostics
- Decided: Jul 22, 2002 after 31 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. The FDA summary names its predicate without a number.
- (no number) Dade Dimension® ISE Standard C D100: named in the summary without a submission number
- (no number) Dade Dimension® ISE Standard A D102: named in the summary without a submission number
- (no number) Dade Dimension® ISE Standard B D103A: named in the summary without a submission number
- (no number) Dade Dimension® ISE Standard C D200: named in the summary without a submission number
- (no number) Dade Dimension® ISE Standard A D202: named in the summary without a submission number
- (no number) Roche Standard 1 for Cobas® ISE Module 46997: named in the summary without a submission number
- (no number) Roche Standard 2 for Cobas® ISE Module 46998: named in the summary without a submission number
- (no number) IL Test™ 7.384 pH Reference Buffer: named in the summary without a submission number
- (no number) IL Test™ 6.840 pH Reference Buffer: named in the summary without a submission number
- (no number) IL Test™ Cal 1: named in the summary without a submission number
- (no number) IL Test™ Cal 2: named in the summary without a submission number

## Indications for use
The products encompassed by this request are intended for in-vitro diagnostics use and are intended for use in calibrating the electrodes and flushing the sample flow path of the equivalent OEM Analyzers.

Source page: https://510kreport.com/device/K022027
Methodology: https://510kreport.com/methodology