(51 days)
Not Found
No
The summary describes a standard enzyme immunoassay for detecting a specific metabolite in urine and does not mention any AI or ML components or capabilities.
No.
This device is an in vitro diagnostic assay used to detect the presence of 6-Acetylmorphine in human urine, which provides a preliminary analytical test result for screening purposes, not for direct treatment or therapy.
Yes
Explanation: The device is an in vitro diagnostic assay intended for the qualitative and/or semi-quantitative determination of a heroin metabolite in human urine, providing a preliminary analytical test result for diagnostic purposes.
No
The device is an in vitro diagnostic assay consisting of buffers and lyophilized reagents, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use Only."
- Purpose: The device is intended for the "in vitro qualitative and/or semi-quantitative determination of the presence of heroin metabolite (6-AM) in human urine." This involves testing a sample (urine) outside of the body to diagnose or provide information about a medical condition or substance presence.
- Target Sample: It analyzes "human urine," which is a biological specimen.
- Setting: It is intended for use in "laboratories" by "trained professionals," which is a typical setting for IVD devices.
N/A
Intended Use / Indications for Use
The CEDIA Heroin Metabolite (6-Acetylmorphine, or 6-AM) Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and/or semi-quantitative determination of the presence of heroin metabolite (6-AM) in human urine at a cut-off concentration of 10 ng/mL. The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect 6-Acetylmorphine in human urine. The assay is designed for use with a number of clinical chemistry analyzers. This product is intended to be used by trained professionals only.
The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) or Liquid chromatography/ mass spectrometry (LC-MS/MS) is the preferred confirmatory method.
Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.
Product codes (comma separated list FDA assigned to the subject device)
DJG
Device Description
The assay consists of buffers (1 and 2) and Ivophilized reagents (1a and 2a). The components include mouse monoclonal antibodies to 6-Acetylmorphine, recombinant microbial enzyme donor (ED) – 6-Acetylmorphine conjugate: enzyme acceptor (EA), chlorophenol red 3-D-galactopyranoside; stabilizers and preservatives. Calibrators and controls are sold separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratories / trained professionals only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance
- Precision: Study performed in accordance with CLSI Guideline EP05-A3. Two runs per day, twice a day, for 20 days (total n=80). Samples were spiked with 6-Acetylmorphine into drug free urine at various concentrations relative to the cutoff (0% to +100%) and tested in qualitative and semi-quantitative modes.
- Qualitative Results: At 10 ng/mL (100% of cutoff), 56 Negative and 24 Positive results out of 80. All samples at +25% cutoff and above were 80 Positive. All samples at -25% cutoff and below were 80 Negative.
- Semi-Quantitative Results: At 10 ng/mL (100% of cutoff), 42 Negative and 38 Positive results out of 80. All samples at +25% cutoff and above were 80 Positive. All samples at -25% cutoff and below were 80 Negative.
- Spike Recovery: Performed for 20 replicates. Tested spiked samples containing 6-Acetylmorphine at cutoff calibrator and control levels. Found all 20 replicates for 7.5 ng/mL were Negative, and all 20 replicates for 12.5 ng/mL were Positive.
- Analytical Recovery and Linearity: Studied linearity in accordance with CLSI Guideline EP06-A. Drug-free urine spiked to 20 ng/mL and diluted to generate 10 intermediate levels. Each sample run in replicates of five in semi-quantitative mode. Recoveries ranged from 97.0% to 113.0%.
- Method Comparison and Accuracy: Study performed in accordance with CLSI Guideline EP09-A3.
- Sample Size: One hundred unaltered patient samples.
- Comparison: Compared to LC-MS/MS.
- Overall Concordance: 99%.
- Qualitative Results: Agreement among Positives: 50/50 = 100%. Agreement among Negative: 49/50 = 98%. One discordant sample (Positive by assay, 9.61 ng/mL by LC-MS/MS) attributed to cross-reactivity with morphine.
- Semi-Quantitative Results: Agreement among Positives: 50/50 = 100%. Agreement among Negative: 49/50 = 98%. One discordant sample (Positive by assay, 9.61 ng/mL by LC-MS/MS) attributed to cross-reactivity with morphine.
- Specificity (Cross-reactivity):
- 6-Acetylmorphine showed 100% cross-reactivity at 10 ng/mL.
- Heroin showed 6% cross-reactivity at 160 ng/mL.
- Various other opiates and structurally related compounds showed negligible cross-reactivity (
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 22, 2017
Microgenics Corporation Minoti Patel Manager, Regulatory Affairs 46500 Kato Road Fremont, California 94538
Re: K173183
Trade/Device Name: CEDIA Heroin Metabolite (6-AM) Assay Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: September 28, 2017 Received: October 2, 2017
Dear Minoti Patel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stayce Beck -A
For: Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173183
Device Name CEDIA Heroin Metabolite (6-AM) Assay
Indications for Use (Describe)
CEDIA Heroin Metabolite (6-AM) Assay:
The CEDIA Heroin Metabolite (6-Acetylmorphine, or 6-AM) Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and/or semi-quantitative determination of the presence of heroin metabolite (6-AM) in human urine at a cut-off concentration of 10 ng/mL. The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect 6-Acetylmorphine in human urine. The assay is designed for use with a number of clinical chemistry analyzers. This product is intended to be used by trained professionals only.
The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) or Liquid chromatography/ mass spectrometry (LC-MS/MS) is the preferred confirmatory method.
Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K173183
510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of Safe Medical Device Act of 1990 and 21 CFR 807.92.
A. Device Information
| Category | Comments |
|---|---|
| Sponsor: | Microgenics Corporation |
| Thermo Fisher Scientific | |
| 46500 Kato Road | |
| Fremont, CA 94538 | |
| Phone: 510-979-5000 | |
| FAX: 510-979-5002 | |
| Correspondent Contact | |
| Information: | Minoti Patel, RAC |
| Manager, Regulatory Affairs | |
| Email: Minoti.patel@thermofisher.com | |
| Phone: 510-979-5000 | |
| FAX: 510-979-5002 | |
| Device Common Name: | 6-Acetylmorphine Immunoassay Test System |
| Trade or Proprietary Name | CEDIA Heroin Metabolite (6-AM) Assay |
| Candidate Device Product | |
| Code, Classification, | |
| Classification,Name & Panel | DJG, Class II, 21 CFR 862.3650 – Opiate test |
| system, 91 – Toxicology |
Predicate Device Information:
| Predicate Device: | CEDIA DAU 6-AcetylmorphineAssay |
|---|---|
| Predicate Device Manufacturer: | Microgenics Corporation |
| Predicate Device Premarket | |
| Notification #: | K001178 |
B. Date Summary Prepared
November 21, 2017
4
C. Description of Device
The assay consists of buffers (1 and 2) and Ivophilized reagents (1a and 2a). The components include mouse monoclonal antibodies to 6-Acetylmorphine, recombinant microbial enzyme donor (ED) – 6-Acetylmorphine conjugate: enzyme acceptor (EA), chlorophenol red 3-D-galactopyranoside; stabilizers and preservatives. Calibrators and controls are sold separately.
D. Intended Use
CEDIA Heroin Metabolite (6-AM) Assay
The CEDIA Heroin Metabolite (6-Acetylmorphine, or 6-AM) Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and/or semi-quantitative determination of the presence of heroin metabolite (6-AM) in human urine at a cut-off concentration of 10 ng/mL. The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect 6-Acetylmorphine in human urine. The assay is designed for use with a number of clinical chemistry analyzers. This product is intended to be used by trained professionals only.
The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures.
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 (GC/MS) or Liquid chromatography/ mass spectrometry (LC-MS/MS) is the preferred confirmatory method.
Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.
| Characteristic | Predicate Device:
CEDIA DAU 6-Acetylmorphine
Assay (K001178) | Candidate Device:
CEDIA Heroin Metabolite
(6-AM) Assay |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Intended Use | A homogeneous enzyme
immunoassay for the in vitro
qualitative or semi-quantitative
determination of 6-
Acetylmorphine in human urine at
a cut-off concentration of 10
ng/mL | Same |
| Operating | CEDIA | Same |
E. Comparison to Predicate Device
5
| Characteristic | Predicate Device:
CEDIA DAU 6-Acetylmorphine
Assay (K001178) | Candidate Device:
CEDIA Heroin Metabolite
(6-AM) Assay |
|---------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Principle
(Technology) | | |
| Measured Analyte | Heroin and 6-Acetylmorphine | Same |
| Test Matrix | Urine | Same |
| Cutoff Levels | 10 ng/mL | Same |
| Methodology | Homogeneous Enzyme
Immunoassay | Same |
| Reagents Form | EA and ED: liquid ready-to-use. | EA and ED: Lyophilized
(Reconstitution Required)
EARB and EDRB liquid
ready-to-use. |
| Antibody | Mouse Monoclonal antibody | Same |
| Storage | 2-8°C until expiration date. | Same |
| Principal
Operator | Trained professionals | Same |
F. Test Principle
The CEDIA Heroin Metabolite Assay uses recombinant DNA technology to produce a homogeneous enzyme immunoassay system. This assay is based on the bacterial enzyme ß-galactosidase, which has been genetically engineered into two inactive fragments. These fragments, termed Enzyme Acceptor (EA) and Enzyme Donor (ED) spontaneously re-associate to form a fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically.
G. Summary of Supporting Data
1. Analytical Performance:
Performance was evaluated at the manufacturer's site on Beckman Coulter AU 680 Analyzer.
a) Precision
Precision studies were performed in accordance with CLSI Guideline EP05-A3. The study was performed for two runs per day, twice a day, for 20 days (total n=80). Samples were prepared by spiking 6-Acetylmorphine methanol stock solution into drug free urine at the cutoff, 25%, 50%, 75% & 100% above and below the cutoff and tested in both qualitative and semi-quantitative modes. The results are summarized in the tables below.
6
| % of Cutoff | Spiked Conc.
(ng/mL) | GC/MS
(ng/mL) | Within Run (n=80) | |
|-------------|-------------------------|------------------|---------------------------|-----------------------------|
| | | | Number of
determinants | Immunoassay
Results |
| -100% | 0 | N/A | 80 | 80 Negative |
| -75% | 2.5 | 2.67 | 80 | 80 Negative |
| -50% | 5 | 5.17 | 80 | 80 Negative |
| -25% | 7.5 | 7.82 | 80 | 80 Negative |
| 100% | 10 | 10.2 | 80 | 56 Negative/
24 Positive |
| +25% | 12.5 | 12.8 | 80 | 80 Positive |
| +50% | 15 | 15.2 | 80 | 80 Positive |
| +75% | 17.5 | 18.0 | 80 | 80 Positive |
| +100% | 20 | 21.5 | 80 | 80 Positive |
Qualitative Results:
Semi-Quantitative Results:
| % of Cutoff | Spiked
Conc.
(ng/mL) | GC/MS
(ng/mL) | Within Run (n=80) | |
|-------------|----------------------------|------------------|---------------------------|-----------------------------|
| | | | Number of
determinants | Immunoassay
Results |
| -100% | 0 | N/A | 80 | 80 Negative |
| -75% | 2.5 | 2.67 | 80 | 80 Negative |
| -50% | 5 | 5.17 | 80 | 80 Negative |
| -25% | 7.5 | 7.82 | 80 | 80 Negative |
| 100% | 10 | 10.2 | 80 | 42 Negative/
38 Positive |
| +25% | 12.5 | 12.8 | 80 | 80 Positive |
| +50% | 15 | 15.2 | 80 | 80 Positive |
| +75% | 17.5 | 18.0 | 80 | 80 Positive |
| +100% | 20 | 21.5 | 80 | 80 Positive |
b) Spike Recovery
The study was performed for 20 replicates using reagents, calibrators and controls. This study was carried out by testing spiked samples containing 6-Acetylmorphine at the cutoff calibrator and controls levels. The spiked samples were prepared by spiking 6-Acetylmorphine into drug free negative urine. Samples were tested in both Qualitative and Semi-Quantitative mode. The qualitative and semi-quantitative results are summarized in the table below.
7
| Replicate | 7.5 ng/mL
(n=20) | 10 ng/mL
(n=20)
(Rate mA/min) | 12.5 ng/mL
(n=20) |
|-----------------|---------------------|-------------------------------------|----------------------|
| 1 | Negative | 515 | Positive |
| 2 | Negative | 513 | Positive |
| 3 | Negative | 515 | Positive |
| 4 | Negative | 515 | Positive |
| 5 | Negative | 516 | Positive |
| 6 | Negative | 513 | Positive |
| 7 | Negative | 512 | Positive |
| 8 | Negative | 519 | Positive |
| 9 | Negative | 515 | Positive |
| 10 | Negative | 517 | Positive |
| 11 | Negative | 517 | Positive |
| 12 | Negative | 518 | Positive |
| 13 | Negative | 518 | Positive |
| 14 | Negative | 517 | Positive |
| 15 | Negative | 515 | Positive |
| 16 | Negative | 516 | Positive |
| 17 | Negative | 520 | Positive |
| 18 | Negative | 515 | Positive |
| 19 | Negative | 516 | Positive |
| 20 | Negative | 518 | Positive |
| Overlap | No | No | No |
| Relative to C/O | All 20 below C/O | N/A | All 20 above C/O |
c) Analytical Recovery and Linearity
Linearity studies were performed in accordance with CLSI Guideline EP06-A. To demonstrate the linearity of the entire assay range, drug free urine was spiked to the high calibrator level (20ng/mL) by using 6-AM methanol solution and diluted with drug free urine to generate 10 intermediate levels.
Each sample was run in replicates of five in semi-quantitative mode and the average was used to determine percent recovery compared to the expected target value. The percent recovery is summarized in the table below.
| Level | Target
Concentration
(ng/mL) | Observed
Concentration
(ng/mL) | Recovery (%) |
|-------|------------------------------------|--------------------------------------|--------------|
| 1 | 0 | 0.18 | N/A |
| 2 | 2 | 2.26 | 113.0 |
| 3 | 4 | 4.02 | 100.5 |
| 4 | 6 | 6.10 | 101.7 |
| 5 | 8 | 7.86 | 98.3 |
| 6 | 10 | 9.88 | 98.8 |
| 7 | 12 | 11.90 | 99.2 |
| 8 | 14 | 13.72 | 98.0 |
8
| 9 | 16 | 15.52 | 97.0 |
|---|---|---|---|
| 10 | 18 | 18.04 | 100.2 |
| 11 | 20 | 19.64 | 98.2 |
d) Method Comparison and Accuracy
The method comparison study was performed in accordance with CLSI Guideline EP09-A3. One hundred unaltered patient samples were analyzed by the CEDIA Heroin Metabolite (6-Acetylmorphine) Assay in both qualitative and semi-quantitative modes and the results are compared to LC-MS/MS. The overall concordance between LC-MS/MS and CEDIA Heroin Metabolite (6-Acetylmorphine) Assay is 99%. The qualitative and semi-quantitative results are summarized in the tables below.
Qualitative Results
| Candidate
Device
Results | Negative | 15.0
ng/mL) |
|--------------------------------|----------|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Positive | 0 | 0 | 1* | 5 | 45 |
| Negative | 43 | 2 | 4 | 0 | 0 |
- Discordant sample
Agreement among Positives: 50/50 =100% Agreement among Negative: 49/50=98%
Semi-Quantitative Results
| Candidate
Device
Results | Negative | 15.0
ng/mL) |
|--------------------------------|----------|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Positive | 0 | 0 | 1* | 5 | 45 |
| Negative | 43 | 2 | 4 | 0 | 0 |
- Discordant sample
Agreement among Positives: 50/50 =100% Agreement among Negative: 49/50=98%
9
* Discordant Result Summary
| Sample ID | CEDIA 6-AM Urine Assay | LC-MS/MS (ng/mL) | |
|---|---|---|---|
| Qualitative mode | Semi-Quantitative mode | 6-Acetylmorphine | |
| CA170418-025 | Positive | Positive | 9.61 |
Sample showed 13.8 ng/mL in semi-quantitative mode, and is discordant due to cross reactivity to morphine present in the sample at a concentration of 4449 ng/mL as measured by LC-MS/MS
e) Specificity
The cross-reactivity of Heroin Metabolite (6-AM) and its metabolites is evaluated by adding known amounts of each analyte to drug-free negative urine. As indicated by the results in the table below, 6-Acetylmorphine showed 100% cross-reactivity. Heroin showed 6% cross-reactivity.
| Heroin Metabolite (6-AM) and its
metabolites | Tested Concentration
(ng/mL) | Cross-
reactivity
(%) |
|-------------------------------------------------|---------------------------------|-----------------------------|
| 6-Acetylmorphine | 10 | 100 |
| Heroin | 160 | 6 |
Cross Reactivity of Structurally Related or Unrelated Opiate Compounds
| Opiates and Structurally Related
Compounds | Tested Concentration
(ng/mL) | Cross-
reactivity (%) |
|-----------------------------------------------|---------------------------------|--------------------------|
| 6-Acetylcodeine | 100,000 | 0.01 |
| Buprenorphine | 100,000 |