# K031159: Calibrating Material, Calibrating Standards

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: Jun 25, 2003 after 72 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
Longest line of descent: 1 generation back to K963763 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963763: Easylyte Sodium/Potassium/Chloride/Lithium Analyzer, Medica Corp. (1996) Summary page 1.
- (no number) Medica EasyLyte Solutions Pack: named in the summary without a submission number
- (no number) IL Test 800 Solutions Pack: named in the summary without a submission number
- (no number) Menarini Spotlyte 800 Solutions Pack: 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. Mission reagents are intended to serve as direct replacements to like named products manufactured by the OEM. The products encompassed are to be handled using normal laboratory precautions.

Source page: https://510kreport.com/device/K031159
Methodology: https://510kreport.com/methodology