# K041747: Impact Test System Saliva Test Module-Opiate (Workplace)

- Pathway: 510(k) (Traditional)
- Applicant: Lifepoint,Inc
- Decided: Nov 24, 2004 after 148 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- 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
For in vitro diagnostic workplace use. The LifePoint® IMPACT® Test System Saliva Test Module (STM) for Opiate is a professional use single-drug test for the rapid determination of Opiate in human saliva. It provides qualitative screening results for Opiate at a cut-off value of 40 ng/mL. The disposable STM is used exclusively with the LifePoint IMPACT Test System instrument. This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmation method. Operators that may use this device are defined as individuals with no prior laboratory testing education or experience, and (1) have received training; a copy of the training checklist, which describes the topics to be covered during this orientation are included in the appendix of the Users Manual, (2) training includes a demonstration of the IMPACT test system and the use of Quality Check (CATALOG #2160) for monitoring and confirming the performance of the test system., (3) trainers monitor operators and confirm their competency and technique in running a test sample and quality control samples, (4) trainers confirm that operators can perform basic troubleshooting procedures, and their understanding of test results, including a discussion of the potential for false positive and false negative results and how to prepare a sample for shipment to a facility for confirmation testing, (5) have reviewed the information contained in the IMPACT Test System Quick Reference Guide and Users Manual., (6) have successfully taken a written exam to verify their competency and obtained a test score of at least 80% on the written examination provided in the appendix of the Users Manual, and (7) have access to assistance from an individual who is experienced in laboratory equipment, and who is familiar with the interpretation of drug testing results. It is the responsibility of those organizations required to follow Department of Transportation (DOT) or Substance Abuse and Mental Health Services Administration (SAMHSA) Workplace Drug Testing Guidelines to determine that use of this product satisfies the criteria for workplace testing established under DOT and SAMHSA authority.

Source page: https://510kreport.com/device/K041747
Methodology: https://510kreport.com/methodology