# K020894: Calibrating Material, Cal-Pak, Buffers

- Pathway: 510(k) (Traditional)
- Applicant: Mission Diagnostics
- Decided: Apr 29, 2002 after 41 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) BP0136 Type 1 Buffer 7.383 AVL: named in the summary without a submission number
- (no number) BP0137 Type 2 Buffer 6.841 AVL: named in the summary without a submission number
- (no number) 473691 pH/Blood Gas pH 7.38 Cal: named in the summary without a submission number
- (no number) 473496 6.8/7.3 Buffer for 248: named in the summary without a submission number
- (no number) 104227 6.8/7.3 Buffer for 348: named in the summary without a submission number
- (no number) 478855D Ciba-Corning 200 Series 7.3: named in the summary without a submission number
- (no number) 478856D Ciba-Corning 200 Series 6.8: named in the summary without a submission number
- (no number) 478864D Ciba-Corning 664 Cal/Wash: named in the summary without a submission number
- (no number) 478865D Ciba-Corning 664 Slope: named in the summary without a submission number
- (no number) 473385D Bayer 800 Series 7.3/Co-0x Zero: named in the summary without a submission number
- (no number) 473386D Bayer 800 Series 6.8 Buffer: named in the summary without a submission number
- (no number) 473387D Bayer 800 Series Wash/Cal G/L Zero: named in the summary without a submission number
- (no number) 570096D Bayer 800 Series Cal G/L: 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. Mission reagents are intended to serve as direct replacements to like named products manufactured by the OEM.

Source page: https://510kreport.com/device/K020894
Methodology: https://510kreport.com/methodology