# K070504: Ammonia/Alcohol Control Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Pointe Scientific, Inc.,
- Decided: Apr 11, 2007 after 49 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
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
The Pointe Scientific, Inc. Ammonia / alcohol Control set is to be used for monitoring the accuracy and precision of various ammonia and / or ethanol assa; methods and to validate quantitation of patient samples. The controls contain components of known concentrations and are an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.

Source page: https://510kreport.com/device/K070504
Methodology: https://510kreport.com/methodology