# K993100: Redi-Screen

- Pathway: 510(k) (Special)
- Applicant: Redwood Biotech, Inc.
- Decided: Oct 6, 1999 after 20 days
- Product code: DJC (Thin Layer Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- 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) Redi-THC: named in the summary without a submission number
- (no number) Redi-PCP: named in the summary without a submission number
- (no number) Redi-Cocaine: named in the summary without a submission number
- (no number) Redi-Opiates: named in the summary without a submission number
- (no number) Redi-Methamphetamine: named in the summary without a submission number

## Indications for use
The Redi-Screen is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of THC, Phencyclidine, Opiates, Cocaine and Methamphetamine at the following cut off concentrations; THC 50ng/mL PCP 25ng/mL Opiates 300ng/mL Cocaine 300ng/mL Methamphetamine 1,000ng/mL The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.

Source page: https://510kreport.com/device/K993100
Methodology: https://510kreport.com/methodology