6-ACETYLMORPHINE Enzyme Immunoassay with Calibrators and Controls
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- 6-Acetylmorphine Enzyme Immunoassay EUDAMEDFDA UDI
- Generic Name
- 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 6-Acetylmorphine Enzyme Immunoassay EUDAMED200 tests. Antibody/Substrate Reagent (R1): 1 x 24.0 mL. Enzyme Conjugate Reagent (R2): 1 x 10.1 mL. FDA UDI
- Model / Reference
- 08240035190 EUDAMEDFDA UDI
- Description
- 200 tests. Antibody/Substrate Reagent (R1): 1 x 24.0 mL. Enzyme Conjugate Reagent (R2): 1 x 10.1 mL. FDA UDI
Identifiers
- Catalog Number
- 08240035190 FDA UDI
- Primary DI / UDI-DI
- 00850624008001 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850624008EIA6AM023M EUDAMED
- Direct Marketing DI
- 00850624008001 EUDAMED
- 510(k) Number
- K101195 FDA 510(k)
- FDA Product Code
- DJG FDA 510(k)FDA UDI
- EMDN Code
- W0102090116 6-ACETHYLMORPHIUM EUDAMED
- GMDN Term
- 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 862.3650 FDA 510(k)
- Regulation Number
- 862.3650 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
This device is an enzyme immunoassay for the qualitative and semi-quantitative detection of 6-acetylmorphine in human urine, classified as an opiate assay. It provides a preliminary analytical result to aid in clinical toxicology screening, with a cutoff value of 10 ng/mL for urine samples.
The assay is designed for use with automated clinical chemistry analyzers and is intended for prescription-based applications. Supplied as a kit with ready-to-use calibrators and controls, it is not sterile and is intended for single-use. The device is authorized under FDA 510(k) and IVDR regulations, adhering to Class II medical device standards.
Frequently asked questions
What clinical scenario is this device intended to support, and how does it assist clinicians?
This device is an enzyme immunoassay designed for clinical toxicology screening to qualitatively and semi-quantitatively detect 6-acetylmorphine in human urine. It provides a preliminary analytical result to help clinicians identify potential heroin or opioid use, with a cutoff value of 10 ng/mL. Since it is intended for use with automated clinical chemistry analyzers, it streamlines workflows in settings like emergency departments, forensic labs, or addiction treatment centers where rapid screening is critical.
Is this assay suitable for use in non-laboratory settings, and what are its key limitations?
The assay is not sterile and is supplied as a kit for single-use only, requiring use with automated clinical chemistry analyzers. While it is authorized for prescription-based applications, its design assumes laboratory infrastructure. Limitations include its qualitative/semi-quantitative nature (not definitive diagnosis) and reliance on urine samples, which may not reflect acute intoxication. Clinicians should correlate results with patient history and confirmatory testing.
How is the kit supplied, and what components are included to ensure accurate testing?
The kit is supplied as a ready-to-use package containing 6-acetylmorphine calibrators and controls alongside the assay reagents. These calibrators and controls are essential for validating assay performance, ensuring accuracy, and maintaining consistency across batches. The inclusion of pre-prepared controls simplifies setup for laboratories, reducing variability in testing workflows.
What regulatory pathways does this device follow, and how does that affect its use in clinical practice?
This device is authorized under FDA 510(k) clearance and IVDR (In Vitro Diagnostic Regulation) in the EU, adhering to Class II medical device standards. The substantially equivalent (SESE) determination by the FDA indicates it meets performance criteria for existing opiate assays, while IVDR compliance ensures traceability and quality standards. Clinicians can rely on its regulatory backing for clinical toxicology applications, though local compliance requirements (e.g., lab accreditation) may still apply.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 6AM, 6-Acetylmorphine Enzyme Immunoassay - Roche Diagnostics USA, PDF LZI 6-Acetylmorphine (6AM) Enzyme Immunoassay - Lin-Zhi, 6-acetylmorphine Enzyme Immunoassay With 6-acetylmorphine Calibrators ...
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K101195 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
Sources (3)
- FDA 510(k) K101195 24 fields · synced Oct 6, 2026
- FDA UDI 74e14468-b9ca-4d34-8a86-1d3b07a59156 35 fields · synced May 30, 2026
- EUDAMED 75c16a1d-7b29-49b3-b554-dc0e0cec0e9a 61 fields · synced Jul 15, 2026