# K982290: Chem-Chex Stat (New)

- Pathway: 510(k) (Traditional)
- Applicant: Streck Laboratories, Inc.
- Decided: Jul 22, 1998 after 23 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K934641 (1993). 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)
- K934641: I-Stat Control  Levels 1,2,3, I-Stat Corp. (1993) Summary page 1.

## Cited in the summary but kept off the family tree
- K96115: Chem-Chex STAT control. Number could not be read Summary page 1.

## Indications for use
Chem-Chex STAT is intended to be used for verifying the accuracy of of i-STAT chemistry analyzers used with i-STAT test cartridges. Chem-Chex STAT is assayed for Na* CI K* BUN, Hgb, Hct, Glucose, pH, and Ca**.

Source page: https://510kreport.com/device/K982290
Methodology: https://510kreport.com/methodology