# K060466: Acon Bup One Step Buprenorphine Test Strip and Acron Bup One Step Buprenorphine Test Device

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Apr 21, 2006 after 58 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.
85 later devices descend from it; 4 cite it directly.
0 of 86 devices 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) FDA-cleared Buprenorphine test: named in the summary without a submission number

## Most influential descendants
- K061718: Innovacon Spectrum II Test Card (2006), 80 descendants of its own
- K122809: Advin Multi-Drug Screen Test Cassette, Dip Card and Cup (2013), 55 descendants of its own
- K140748: One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard (2014), 16 descendants of its own
- K182701: Wondfo T-Cup Multi-Drug Urine Test Cup (2018), 13 descendants of its own
- K142800: Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard (2014), 13 descendants of its own

## Indications for use
The ACON BUP One Step Buprenorphine Test Strip and the ACON BUP One Step Buprenorphine Test Device are rapid chromatographic immunoassays for the qualitative detection of Buprenorphine in human urine at a designated cutoff concentration of 10 ng/mL. They are intended for use by healthcare professionals including professionals at point-of-care sites to assist in the determination of drug compliance. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Liquid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K060466
Methodology: https://510kreport.com/methodology