# K041696: Rapid Reader

- Pathway: 510(k) (Traditional)
- Applicant: American Bio Medica Corp.
- Decided: Jul 12, 2005 after 385 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- 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 K973547 (1998). 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)
- K973547: Triage Statmeter, Biosite Incorporated (1998) Summary page 2.

## Indications for use
The Rapid Reader System is a reader designed to capture, document and archive ABMC Drug of abuse test results using Rapid Drug Screen®, Rapid One®, and Rapid TEC® screening immunoassays ("ABMC tests"). The Rapid Reader is used to obtain qualitative results amid is intended for professional use only. This Reader, combined with ABMC tests is a simplified qualitative screening method that provides a preliminary indication of drugs in urine. Results should be confirmed using appropriate confirmation methods. i.e., gas-chromatography/mass spectrometry (GCIMS). After having performed the ABMC tests (according to instructions for use of each ABMC tests) the ABMC test is inserted into the device holder of the Rapid Reader. The Rapid Reader scans the device, and the results are displayed. The performance characteristics of the device have not been determined for use at point of care. This statement of inted d u included in the operation manual.

Source page: https://510kreport.com/device/K041696
Methodology: https://510kreport.com/methodology