# K040316: Cedia Buprenorphine Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Jun 23, 2004 after 135 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
Longest line of descent: 1 generation back to K001178 (2000). 1 ancestor in all.
52 later devices descend from it; 6 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001178: Cedia Dau 6-Acetylmorphine Assay, Microgenics Corp. (2000) Summary page 1.
- (no number) GC/MS: named in the summary without a submission number

## Most influential descendants
- K150606: Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive (2015), 25 descendants of its own
- K161216: Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators (2017), 23 descendants of its own
- K180427: ARK Fentanyl Assay (2018), 19 descendants of its own
- K042988: Rapid One Step Buprenorphine Test Card (2005), 18 descendants of its own
- K220046: Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 (2022), 17 descendants of its own

## Indications for use
The CEDIA® Buprenorphine assay is a homogenous enzyme immunoassay for qualitative or semi-quantitative determination of the presence of buprenorphine in human urine at cutoff concentration of 5 ng/mL. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine. The CEDIA® Buprenorphine calibrators are used to calibrate the CEDIA® Buprenorphine Assay in human urine. The CEDIA® Buprenorphine controls are used to qualify the CEDIA® Buprenorphine Assay in human urine. The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GCIMS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test resuIt articularly when preliminary results are used.

Source page: https://510kreport.com/device/K040316
Methodology: https://510kreport.com/methodology