# K020596: Calibrating Material,Cal-Pak, Cal & Slope Standards

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: Mar 23, 2002 after 29 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) 614 Cal-Pak Na+/K+: named in the summary without a submission number
- (no number) 634 Cal-Pak Ca++/pH: named in the summary without a submission number
- (no number) 644 Cal-Pak Na+/K+/Cl-: named in the summary without a submission number
- (no number) 654 Cal-Pak Na+/K+/Li+: 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 for use in calibrating the electrodes and flushing the sample flow path of the equivalent Corning 6X4 Series Electrolyte Analyzers. Corning (name changes incl.: Corning Glass, Ciba-Corning, Chiron, and currently Bayer) is the Original Equipment Manufacturer (OEM) of the analyzers and the predicate reagents. Mission reagents are intended to serve as direct replacements to like named products manufactured by Corning (under the label of current owner, Bayer). The products encompassed are to be handled using normal laboratory precautions.

Source page: https://510kreport.com/device/K020596
Methodology: https://510kreport.com/methodology