# K102779: Emit II PLUS6-Acetylmorphine Assay; Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level 1; Emit II Plus 6-AM / Ectasy C

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Mar 18, 2011 after 175 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010496 (2001). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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 4.
- K043028: Emit II Plus Ecstasy Assay, Dade Behring, Inc. (2005) Summary page 2.

## Most influential descendants
- K150275: Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls (2015), 0 descendants of its own

## Recalls of this device
- Mar 12, 2018 · Class III · Z-1800-2018: Incorrect calibrator level listed in qualitative calibration steps
- Mar 12, 2018 · Class III · Z-1799-2018: Incorrect calibrator level listed in qualitative calibration steps

## Indications for use
The Emit® 11 Plus 6-Acetylmorphine Assay is a homogeneous enzyme immunoassay with 10 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of 6-acetylmorphine (6-AM), a heroin metabolite, in human urine. Emit® 11 Plus assays are designed for use with a number of chemistry analyzers. Semiquantitative test results may be used to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by GC/MS. The Emit® 11 Plus 6-Acetylmorphine 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 (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used. Calibrators are used in the calibration of the Emit® 11 Plus 6-Acetylmorphine and Emit® 11 Plus Ecstasy Assays. Controls may be used as quality control materials based on the specific Emit® 11 Plus 6-Acetylmorphine and Emit® 11 Plus Ecstasy Assay cutoffs.

Source page: https://510kreport.com/device/K102779
Methodology: https://510kreport.com/methodology