# K981436: Document Ammonia/Ethanol/Lactate Calibrator, PN: M-109

- Pathway: 510(k) (Special)
- Applicant: Casco Standards
- Decided: Apr 24, 1998 after 10 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This product is intended for in vitro diagnostic for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems for the measurement of ammonia, ethanol and lactate. Each lot of DOCUMENT Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set-point values for the various analytical systems on which it was assayed. This material is not intended for use on those clinical-chemistry systems employing reflectance spectroscopy.

Source page: https://510kreport.com/device/K981436
Methodology: https://510kreport.com/methodology