# K033114: Ketochecks

- Pathway: 510(k) (Traditional)
- Applicant: Neo Diagnostics, Inc.
- Decided: Apr 26, 2004 after 209 days
- Product code: JIN (Nitroprusside, Ketones (Urinary, Non-Quant.))
- Device class: 1
- Regulation: 21 CFR 862.1435
- 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) Bayer Ketostix reagent strips: named in the summary without a submission number

## Indications for use
The Neo Diagnostics KetoChecks is intended for the identification of ketones in urine and can be used in the diagnosis of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as Acetoacetic acid) and for monitoring patients on ketogenic diets and patients with diabetes. The test is indicated for use by professionals and for Over the Counter use by lay people.

Source page: https://510kreport.com/device/K033114
Methodology: https://510kreport.com/methodology