(65 days)
Not Found
No
The device description details a standard enzyme immunoassay based on chemical reactions and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic assay used for the qualitative and/or semiquantitative analysis of MDMA in human urine, which provides preliminary analytical test results and is not intended for treatment or direct therapy.
Yes
The device is used for the qualitative and/or semi-quantitative analysis of MDMA and related drugs in human urine, providing a preliminary analytical test result. This is a common function of diagnostic devices.
No
The device is a homogeneous enzyme immunoassay, which is a chemical assay kit, not a software-only device. It is intended for use with chemistry analyzers, which are hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states the assay is "intended for use in laboratories for the qualitative and/or semiquantitative analysis of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine." This clearly indicates the device is used to examine specimens derived from the human body (urine) to provide information for diagnostic purposes (detecting the presence of MDMA).
- Device Description: The description details a "homogeneous enzyme immunoassay" that analyzes "specific compounds in human urine." This further confirms the use of the device on human biological samples.
- Performance Studies: The document describes testing the assay with "urine specimens," reinforcing its use with human samples.
- Predicate Devices: The listed predicate devices (DRI® Ecstasy Enzyme Immunoassay, DRI® Ecstasy Urine Calibrators, Emit® Calibrator/Control) are also IVDs, indicating the regulatory classification of similar devices.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this specific assay is for drug detection, which might not always be directly for diagnosing a disease, it falls under the broader scope of IVDs as it provides information about the state of a person's body (presence of a substance) through the analysis of a human specimen.
N/A
Intended Use / Indications for Use
The Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 500 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analysis of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine. Emit® II Plus Assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Ecstasy 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.
The Emit® II Plus Ecstasy Calibrators / Controls are used in the calibration of the Emit® II Plus Ecstasy Assay. These standards may also be used as quality control materials based upon the Ecstasy assay cutoff.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DLJ, DIF
Device Description
Assay
The Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay used for the analysis of specific compounds in human urine. The assay is based on competition between drug in the specimen and drug labeled with recombinant ofucose-6-phosphate dehydrogenase (rG6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme NAD functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.
Calibrator / Control
The Emit® II Plus Ecstasy Calibrators / Controls are liquid, four-level calibrators prepared from MDMA, urine and preservatives.
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
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)
A. 300 ng/mL cutoff
One hundred (100) urine specimens were tested with the Emit® II Plus Ecstasy Assay on the SYVA®-30R Biochemical System. Results were compared to the reference method (GC/MS). The Assay used a cutoff level of 300 nq/mL for MDMA.
Fifty-seven (57) samples were found to be positive by GC/MS (≥200 ng/mL MDMA, MDEA or MDA using UK quidelines) and fifty-five (55) were found to be positive by the Emit® II Plus Ecstasy Assay.
Forty-three (43) samples were found to be negative by GC/MS (
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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
Dade Behring Inc.
510(k) Notification - Emit® II Plus Ecstasy Assay and Emit® II Plus Ecstasy Calibrators / Controls
510(k) Summary Emit® II Plus Ecstasy Assay and Emit® II Plus Ecstasy Calibrators / Controls
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation
Manufacturer:
Dade Behring Inc. 20400 Mariani Ave. Cupertino, CA 95014
| Contact Information: | Dade Behring Inc. |
|---|---|
| P.O. Box 6101 | |
| Newark, DE 19714 | |
| Attn: Yuk-Ting Lewis | |
| Tel: 302-631-7626 |
Date of Preparation:
Nov. 1, 2004
Device Name / Classification 2.
Emit® II Plus Ecstasy Assay: Amphetamine Test System Classification: Class II (862.3100)
Emit® II Plus Ecstasy Calibrators / Controls: Clinical Toxicology Calibrator Classification: Class II (862.3200)
Emit® II Plus Ecstasy Calibrators / Controls: Clinical Toxicology Control Classification: Class I (862.3280)
3. Identification of the Legally Marketed Device
DRI® Ecstasy Enzyme Immunoassay, K012110 DRI® Ecstasy Urine Calibrators, K012109 Emit® Calibrator/Control, K993755.
1
4. Device Description
Assav
The Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay used for the analysis of specific compounds in human urine. The assay is based on competition between drug in the specimen and drug labeled with recombinant ofucose-6-phosphate dehydrogenase (rG6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH in the presence of glucose-6-phosphate (G6P), resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme NAD functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.
Calibrator / Control
The Emit® II Plus Ecstasy Calibrators / Controls are liquid, four-level calibrators prepared from MDMA, urine and preservatives.
5. Device Intended Use
Assay
The Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 500 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analysis of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Ecstasy 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.
Calibrator / Control
The Emit® II Plus Ecstasy Calibrators / Controls are used in the calibration of the Emit® II Plus Ecstasy Assay. These standards may also be used as quality control materials based upon the Ecstasy assay cutoff.
2
Dade Behring Inc.
510(k) Notification - Emit® II Plus Ecstasy Assay and Emit® II Plus Ecstasy Calibrators / Controls
6. Medical device to which equivalence is claimed and comparison information
Assay
The Emit® II Plus Ecstasy Assav is substantially equivalent in intended use and methodology to the Microgenics DR1® Ecstasy Enzvme Immunoassay (K012110). Both devices are enzyme immunoassays intended for use in the qualitative and semiquantitative determination of ecstasy drugs in human urine. The Emit® II Plus Ecstasy Assay has two cutoffs: 300 ng/mL and 500 ng/mL, while the DRI® Assay has a single cutoff at 500 ng/mL.
Comparison Information
A. 300 ng/mL cutoff
One hundred (100) urine specimens were tested with the Emit® II Plus Ecstasy Assay on the SYVA®-30R Biochemical System. Results were compared to the reference method (GC/MS). The Assay used a cutoff level of 300 nq/mL for MDMA.
Fifty-seven (57) samples were found to be positive by GC/MS (≥200 ng/mL MDMA, MDEA or MDA using UK quidelines) and fifty-five (55) were found to be positive by the Emit® II Plus Ecstasy Assay.
Forty-three (43) samples were found to be negative by GC/MS ( Trade/Device Name: Emit® II Plus Ecstasy Assay Emit® II Plus Ecstasy Calibrator / Control Level 1 Emit® II Plus Ecstasy Calibrator / Control Level 2 Emit® II Plus Ecstasy Calibrator / Control Level 3 Emit® II Plus Ecstasy Calibrator / Control Level 4 Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DLJ, DIF Dated: November 2, 2004 Received: November 3, 2004
Dear Yuk-Ting Lewis:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
8
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin finaling of substantial equivalence of your device to a legally prematication of the results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, If you desire specific infortion and advertising of your device, please contact the Office of In or questions on the promotion and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the r ou may obtain of Senall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sincerely yours,
Camila B. Pools
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
9
Dade Behring Inc.
510(k) Notification - Emit® II Plus Ecstasy Assay and Emit® II Plus Ecstasy Calibrators / Controls
Indications for Use
510(k) Number (if known):
KO43028 Emit® Il Plus Ecstasy Assay
Device Name:
2017年07月11日 08:00:00 PM 10:00 PM 11:00 PM 11:00 PM 11:00 PM 20:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 11:00 PM 1
Emit® II Plus Ecstasy Calibrator / Control Level 1 Emit® Il Plus Ecstasy Calibrator / Control Level 2 Emit® II Plus Ecstasy Calibrator / Control Level 3 Emit® Il Plus Ecstasy Calibrator / Control Level 4
Indications For Use:
The Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 500 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analysis of methylenedioxymethamphetamine (MDMA) and closely related drugs in human urine. Emit® II Plus Assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Ecstasy 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.
The Emit® II Plus Ecstasy Calibrators / Controls are used in the calibration of the Emit® Il Plus Ecstasy Assay. These standards may also be used as quality control materials based upon the Ecstasy assay cutoff.
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benson
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K043028
00008