(233 days)
Not Found
No
The device description and performance studies focus on a homogeneous enzyme immunoassay for drug detection, which is a traditional chemical analysis method. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in medical devices.
No.
This device is an in vitro diagnostic assay used for screening the presence of ecstasy drugs in human urine. It is not intended for treating or diagnosing any condition.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended for the qualitative or semiquantitative determination of ecstasy drugs in human urine" and provides "a preliminary analytical test result," which are general characteristics of a diagnostic device used for screening or detecting substances indicative of a condition or exposure.
No
The device is a homogeneous enzyme immunoassay, which is a chemical assay requiring reagents and laboratory equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative or semiquantitative determination of ecstasy drugs in human urine." This involves testing a biological sample (urine) outside of the body to gain information about a person's health status (presence of drugs).
- Device Description: The description reinforces that it's a "homogeneous enzyme immunoassay intended for the qualitative or semiquantitative determination of ecstasy drugs in human urine."
- Care Setting: It is intended for use in "clinical laboratories only," which is a typical setting for IVD testing.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The DRI™ Ecstasy Plus Assay is a homogeneous enzyme immunoassay intended for the qualitative or semiquantitative determination of ecstasy drugs in human urine. The assay provides a simple and rapid analytical screening procedure for detecting ecstasy drugs at a cutoff level of 500 ng/mL. The product is intended for use in clinical laboratories only.
This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography with tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Product codes (comma separated list FDA assigned to the subject device)
DKZ
Device Description
DRI Ecstasy Plus Assay is a homogeneous enzyme immunoassay intended for the qualitative or semiquantitative determination of ecstasy drugs in human urine. The assay provides a simple and rapid analytical screening procedure for detecting ecstasy drugs at a cutoff level of 500 ng/mL.
DRI Ecstasy Plus Assay is a class assay. Ecstasy drugs represent a group of ring substituted methylenedioxy analogues of amphetamine including 3, 4 methylenedioxyamphetamine (MDA), 3, 4 - methylenedioxymethamphetamine (MDMA) and 3, 4 - methylenedioxyethylamphetamine (MDEA). They are central nervous system (CNS) stimulants popularly abused for their psychotropic effects and are listed by the U.S. Drug Enforcement Administration as Schedule | (no accepted medical application with great abuse potential). At low dose, both MDMA and MDA produce euphoria, increased self-awareness, and an increased sense of trust. At higher doses, they are thought to be hallucinoqenic. Toxic effects are similar to those of other CNS stimulants and include anxiety, depression, tachycardia, elevated blood pressure, cardiac arrhythmias, pupil dilation, and sleep disorders.
The length of time following drug use for which a positive result may occur is dependent upon several factors including the frequency and amount of drug, metabolic rate, excretion rate, drug half-life and the drug user's age, weight, activity and diet. Within the body, MDMA is known to metabolize to MDA by N-demethylation. Urinary excretion accounts for 65% of the dose as parent drug and 7% as MDA within 3 days. Urinary MDMA concentrations following a 1.5 mg/kg oral dose may exceed 17 mg/L. Other urinary metabolites include mono- and dihydroxy-derivatives of MDMA and MDA, resulting from fission of the methylene bridge, which are eliminated as conjugates. The human metabolism of MDA has not been studied. Urine concentrations in fatal cases of up to 160 mg/L have been recorded and are indicative of excretion of substantial portions of unchanged drugs.
Therefore, DRI Ecstasy Plus Assay is a first-line device, which may be used by medical personnel, along with clinical observations, as an aid to diagnosis of ecstasy abuse.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical laboratories only.
Trained professionals
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)
Precision: In Qualitative, assay within run is ≤ 2% CV and total run precision is ≤ 5.0 % CV. In Semi-Quantitative, assay within run is ≤ 5% CV and total run precision is ≤ 7.5 % CV.
Method Comparison: Negative sample agreement is 100% in both Qualitative and Semi-Quantitative modes. Positive sample agreement is 100% in both Qualitative and Semi-Quantitative modes. Overall sample agreement is 100% for DRI Ecstasy Plus assay in both Qualitative and Semi-Quantitative mode.
Specificity: Structurally related compounds that produced a positive result above the cut-off calibrator were reported at lowest concentrations. Structurally related compounds that produced a negative result below the cut-off calibrator were reported at the highest concentrations. Structurally unrelated compounds shall produce a negative result below the 500 ng/mL MDMA sample in both Qualitative and Semi-quantitative modes at the concentrations tested. In both Qualitative and Semi-quantitative modes, assay produced a negative result below the 500 ng/mL MDMA cutoff when structurally unrelated compounds were spiked into negative pool urine at the tested concentrations.
Interference: In Qualitative mode, the rates of the low control samples spiked with interfering substances and pH adjusted were negative, and the rates of the high control samples spiked with interference substances and pH adjusted were positive. In Qualitative mode, the rates of the low control level samples were negative, and the rates of the high control level samples were positive. In Semi-quantitative mode, the recovery of the low control level sample spiked with interfering substances and pH adjusted were within 80 - 120% of the nominal value of 375 ng/mL, and recovery of the high control level sample spiked with interfering substances and pH adjusted were within 80 - 120% of the nominal value of 625 ng/mL ng/mL.
Stability: The results from the open-vial condition (in-use) demonstrated that three lots of DRI Ecstasy Plus Reagent Kit, 500 mL kit met the acceptance criteria. The results demonstrate that the product is stable over the shelf life once opened and stored tightly capped at 2-8°C. These results support the claim that the DRI Ecstasy Plus Reagent Kit, 500mL kits are stable for 36 months when stored unopened at 2-8°C.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Information on %CV and agreement for method comparison provided.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
Microgenics Corporation Amrit Takhar Regulatory Affairs Specialist III 46500 Kato Road Fremont, California 94538
Re: K240670
Trade/Device Name: DRI™ Ecstasy Plus Assay Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ Dated: October 4, 2024 Received: October 4, 2024
Dear Amrit Takhar:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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
1
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Joseph A. Joseph A. Kotarek =S Kotarek -S Date: 2024.10.30 09:41:12 -04'00" Joseph Kotarek, Ph.D. Branch Chief for Toxicology Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K240670
Device Name DRI™ Ecstasy Plus Assay
Indications for Use (Describe)
The DRI™ Ecstasy Plus Assay is a homogeneous enzyme immunoassay intended for the qualitative or semiquantitative determination of ecstasy drugs in human urine. The assay provides a simple and rapid analytical screening procedure for detecting ecstasy drugs at a cutoff level of 500 ng/mL. The product is intended for use in clinical laboratories only.
This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/GC/MS) or Liquid chromatography with tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510K Summary K240670
l. Device Information
| Contact Details | |
|---|---|
| Sponsor: | Microgenics Corporation Thermo Fisher |
| Scientific 46500 Kato Road | |
| Fremont, CA 94538 | |
| Phone: 510-979-5000 | |
| FAX: 510-979-5002 | |
| Correspondent Contact Information: | Amrit Takhar |
| Regulatory Affairs Specialist III, | |
| Regulatory Affairs | |
| Email: Amrit.Takhar@thermofisher.com | |
| Phone: 510- 771-5935 | |
| FAX: 510-979-5002 | |
| Device Name | |
| Device Trade Name: | DRI TM Ecstasy Plus Assay |
| Common Name: | Amphetamine Test System |
| Classification Name: | Enzyme Immunoassay, Amphetamine |
| Regulation Number: | 862.3100 |
| Product Code: | DKZ |
| Legally Marketed Predicate Device | |
| Predicate Premarket Notification Number: | K012110 |
| Predicate Trade Name: | DRI Ecstasy Enzyme Immunoassay |
| Predicate Common Name: | Amphetamine Test System |
| Predicate Classification Name: | Enzyme Immunoassay, Amphetamine |
| Predicate Regulation Number: | 862.3100 |
| Predicate Product Code: | DKZ |
II. Date Summary Prepared
March 8, 2024
lll. Description of Device
DRI Ecstasy Plus Assay is a homogeneous enzyme immunoassay intended for the qualitative or semiquantitative determination of ecstasy drugs in human urine. The assay provides a simple and rapid analytical screening procedure for detecting ecstasy drugs at a cutoff level of 500 ng/mL.
DRI Ecstasy Plus Assay is a class assay. Ecstasy drugs represent a group of ring substituted methylenedioxy analogues of amphetamine including 3, 4 methylenedioxyamphetamine (MDA), 3, 4 - methylenedioxymethamphetamine (MDMA) and 3, 4 - methylenedioxyethylamphetamine (MDEA). They are central nervous system
4
(CNS) stimulants popularly abused for their psychotropic effects and are listed by the U.S. Drug Enforcement Administration as Schedule | (no accepted medical application with great abuse potential). At low dose, both MDMA and MDA produce euphoria, increased self-awareness, and an increased sense of trust. At higher doses, they are thought to be hallucinoqenic. Toxic effects are similar to those of other CNS stimulants and include anxiety, depression, tachycardia, elevated blood pressure, cardiac arrhythmias, pupil dilation, and sleep disorders.
The length of time following drug use for which a positive result may occur is dependent upon several factors including the frequency and amount of drug, metabolic rate, excretion rate, drug half-life and the drug user's age, weight, activity and diet. Within the body, MDMA is known to metabolize to MDA by N-demethylation. Urinary excretion accounts for 65% of the dose as parent drug and 7% as MDA within 3 days. Urinary MDMA concentrations following a 1.5 mg/kg oral dose may exceed 17 mg/L. Other urinary metabolites include mono- and dihydroxy-derivatives of MDMA and MDA, resulting from fission of the methylene bridge, which are eliminated as conjugates. The human metabolism of MDA has not been studied. Urine concentrations in fatal cases of up to 160 mg/L have been recorded and are indicative of excretion of substantial portions of unchanged drugs.
Therefore, DRI Ecstasy Plus Assay is a first-line device, which may be used by medical personnel, along with clinical observations, as an aid to diagnosis of ecstasy abuse.
IV. Intended Use
A. Indications for Use:
See indications for use below.
B. Intended Use:
The DRI™ Ecstasy Plus Assay is a homogeneous enzyme immunoassay intended for the qualitative or semiquantitative determination of ecstasy drugs in human urine. The assay provides a simple and rapid analytical screening procedure for detecting ecstasy drugs at a cutoff level of 500 ng/mL. The product is intended for use in clinical laboratories only.
This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography with tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
V. Comparison to Predicate Device
5
| Characteristics | Predicate Device
DRI Ecstasy Enzyme
Immunoassay (K012110) | Candidate Device
DRI Ecstasy Plus Assay | Comparison |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | See intended use below for
indications use | See intended use below for
indications use | Identical |
| Intended Use | The DRI Ecstasy Enzyme
Immunoassay is a homogeneous
enzyme immunoassay intended
for the qualitative or
semiquantitative determination of
ecstasy drugs in human urine.
The assay provides a simple and
rapid analytical screening
procedure for detecting ecstasy
drugs at a Cutoff level of
500ng/mL. The product is
intended for use in clinical
laboratories only.
This assay provides only a
preliminary analytical test result.
A more specific alternate
chemical method must be used
in order to obtain a confirmed
analytical result. Gas
chromatography/ mass
spectrometry (GC/MS) is the
preferred confirmatory method.
Clinical consideration and
professional judgment should be
applied to any drug of abuse test
result, particularly when
preliminary positive results are
used. | The DRITM Ecstasy Plus Assay
is a homogeneous enzyme
immunoassay intended for the
qualitative or semiquantitative
determination of ecstasy drugs in
human urine. The assay provides
a simple and rapid analytical
screening procedure for
detecting ecstasy drugs at a
cutoff level of 500 ng/mL. The
product is intended for use in
clinical laboratories only.
This assay provides only a
preliminary analytical test result.
A more specific alternative
chemical method must be used
in order to obtain a confirmed
analytical result. Gas
chromatography/mass
spectrometry (GC/MS) or Liquid
chromatography with tandem
mass spectrometry (LC-MS/MS)
is the preferred confirmatory
method. Clinical consideration
and professional judgment
should be applied to any drug of
abuse test result, particularly
when preliminary positive results
are used. | Identical
with
expectation
to additional
confirmatory
method
option
added. This
does not
impact the
intended
use of
device. |
| FDA Product
Code | DKZ | DKZ | Identical |
| Device
Classification
and Name | 21 CFR 862.3100
Amphetamine Test System | 21 CFR 862.3100
Amphetamine Test System | Identical |
| Operating
Principle
(Technology) | DRI | DRI | Identical |
| Analyte | Ecstasy | Ecstasy | Identical |
| Measured
Analyte | 3, 4 -
methylenedioxyamphetamine
(MDA)
3, 4 -
methylenedioxymethamphetamin
e (MDMA) | 3, 4 -
methylenedioxyamphetamine
(MDA)
3, 4 -
methylenedioxymethamphetami
ne (MDMA) | Identical |
| Test Matrix | Human Urine | Human Urine | Identical |
| Characteristics | Predicate Device
DRI Ecstasy Enzyme
Immunoassay (K012110) | Candidate Device
DRI Ecstasy Plus Assay | Comparison |
| Cut-off Levels | 500 ng/mL | 500 ng/mL | Identical |
| Methodology | Homogeneous Enzyme
Immunoassay | Homogeneous Enzyme
Immunoassay | Identical |
| Materials | Antibody/Substrate Reagent
(R1) contains mouse monoclonal
anti-MDMA antibody, glucose-6-
phosphate (G6P), and
nicotinamide adenine
dinucleotide (NAD) in Tris buffer
with sodium azide as a
preservative.
Enzyme Conjugate Reagent
(R2) contains MDMA labeled
with glucose-6-phosphate
dehydrogenase (G6PDH) in Tris
buffer with sodium azide as a
preservative. | Antibody/Substrate Reagent
(R1) contains mouse
monoclonal anti-MDMA
antibody, glucose-6-phosphate
(G6P), and nicotinamide
adenine dinucleotide (NAD) in
Tris buffer with sodium azide as
a preservative.
Enzyme Conjugate Reagent
(R2) contains MDMA labeled
with glucose-6-phosphate
dehydrogenase (G6PDH) in
Tris buffer with sodium azide as
a preservative. | Identical |
| Reagent Form | Reagents are sold in two sizes,
100 mL and 500 mL kits. | Reagents are sold in one size,
500 mL kit. | Identical |
| Antibody | Mouse Monoclonal Antibodies | Mouse Monoclonal Antibodies | Identical |
| Storage | 2-8°C until expiration date | 2-8°C until expiration date | Identical |
| Principal
Operator | Trained professionals | Trained professionals | Identical |
| Instrument | Hitachi 717 | Abbott Architect C4000 | Different |
| Package Insert | Header and Footer
Additional Material
Precautious and Warning
Specimen Collection and
Preparation
Reference | Header and Footer
Additional Material
Precautious and Warning
Specimen Collection and
Preparation
Reference | Different |
| Product
Labeling | Kit Labeling
Component Labeling | Kit Labeling
Component Labeling | Different |
| Performance
Characteristics | Precision
Accuracy
Specificity (structurally related)
Sensitivity | Precision
Accuracy
Specificity (structurally related) | Different |
6
7
VI. Summary of Performance Testing
A. Precision:
In Qualitative, assay within run is ≤ 2% CV and total run precision is ≤ 5.0 % CV. In Semi-Quantitative, assay within run is ≤ 5% CV and total run precision is ≤ 7.5 % CV
B. Method Comparison:
Negative sample agreement is 100% in both Qualitative and Semi-Quantitative modes. Positive sample agreement is 100% in both Qualitative and Semi-Quantitative modes. Overall sample agreement is 100%for DRI Ecstasy Plus assay in both Qualitative and Semi-Quantitative mode.
C. Specificity:
Structurally related compounds that produced a positive result above the cut-off calibrator were reported at lowest concentrations.
Structurally related compounds that produced a negative result below the cut-off calibrator were reported at the highest concentrations.
Structurally unrelated compounds shall produce a negative result below the 500 ng/mL MDMA sample in both Qualitative and Semi-quantitative modes at the concentrations tested.
In both Qualitative and Semi-quantitative modes, assay produced a negative result below the 500 ng/mL MDMA cutoff when structurally unrelated compounds were spiked into negative pool urine at the tested concentrations.
Interference
In Qualitative mode, the rates of the low control samples spiked with interfering substances and pH adjusted were negative, and the rates of the high control samples spiked with interference substances and pH adjusted were positive.
In Qualitative mode, the rates of the low control level samples were negative, and the rates of the high control level samples were positive.
In Semi-quantitative mode, the recovery of the low control level sample spiked with interfering substances and pH adjusted were within 80 - 120% of the nominal value of 375 ng/mL, and recovery of the high control level sample spiked with interfering substances and pH adjusted were within 80 - 120% of the nominal value of 625 ng/mL ng/mL.
D. Stability:
The results from the open-vial condition (in-use) demonstrated that three lots of DRI Ecstasy Plus Reagent Kit, 500 mL kit met the acceptance criteria. The results demonstrate that the product is stable over the shelf life once opened and stored tightly
8
capped at 2-8°C. These results support the claim that the DRI Ecstasy Plus Reagent Kit, 500mL kits are stable for 36 months when stored unopened at 2-8°C.
VII. Conclusion
The information supports a determination of substantial equivalence between the candidate device DRI Ecstasy Plus and the predicate device DRI Ecstasy Enzyme lmmunoassay (K012110).