# K974428: Dipstreak

- Pathway: 510(k) (Traditional)
- Applicant: Novamed, Ltd.
- Decided: Jul 30, 1998 after 248 days
- Product code: JSI (Culture Media, Selective And Differential)
- Device class: 1
- Regulation: 21 CFR 866.2360
- 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 K921045 (1992). 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)
- K921045: Diaslide Urine Culturing Device, Savyon Diagnostics, Ltd. (1992) Summary page 1.

## Indications for use
The Novamed, Ltd. DipStreak Urine Culture Device is used for the isolation and enumeration of bacteria in urine. A set of plastic prongs on the end of the device are dipped into the urine sample. The drops of urine which adhere to the prongs are then streaked across two different agar surfaces (CLED agar on one side, MacConkey agar on the other). A dilution effect takes place which allows the isolation of single colonies.

Source page: https://510kreport.com/device/K974428
Methodology: https://510kreport.com/methodology