K Number
K012110
Device Name
DRI ECSTASY ENZYME IMMUNOASSAY
Manufacturer
Date Cleared
2001-08-27

(52 days)

Product Code
Regulation Number
862.3100
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 500 ng/mL. 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.
Device Description
The DRI Ecstasy Assay is a liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies, which can detect ecstasy drugs in urine with minimal cross-reactivity to various amphetamine compounds. The assay is based on competition between a drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme, and free drug from the urine sample for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the specific antibody binds the drug labeled with G6PDH causing a decrease in enzyme activity. This phenomenon creates a direct relationship between drug concentration in urine and enzyme activity. The enzyme G6PDH activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.
More Information

Not Found

No
The device description and performance studies describe a standard enzyme immunoassay based on chemical reactions and spectrophotometric measurement, with no mention of AI or ML algorithms.

No.

The device is an in vitro diagnostic (IVD) immunoassay designed for the qualitative or semiquantitative determination of ecstasy drugs in human urine. It is used for screening purposes to detect drugs of abuse and provides analytical test results, not direct therapeutic treatment or diagnosis of a condition in a patient.

Yes.
The device is intended for the qualitative or semiquantitative determination of ecstasy drugs in human urine, which is a diagnostic purpose.

No

The device description clearly outlines a homogeneous enzyme immunoassay that involves chemical reactions and spectrophotometric measurements, indicating it is a laboratory-based assay kit with physical components, not software only.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states the determination of ecstasy drugs in human urine. This is a biological sample taken from the human body.
  • Method: The device uses a homogeneous enzyme immunoassay, which is a laboratory test performed in vitro (outside the body).
  • Purpose: The purpose is to provide a preliminary analytical test result for detecting ecstasy drugs, which is a diagnostic purpose related to drug use.

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 drug screening isn't always directly diagnosing a disease, it falls under the broader scope of determining a state of health or condition (drug use). The fact that it analyzes a human biological sample in vitro for a specific substance strongly indicates it is an IVD.

N/A

Intended Use / Indications for 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 500 ng/mL.

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.

Product codes

DKZ

Device Description

The DRI Ecstasy Assay is a liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies, which can detect ecstasy drugs in urine with minimal cross-reactivity to various amphetamine compounds. The assay is based on competition between a drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme, and free drug from the urine sample for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the specific antibody binds the drug labeled with G6PDH causing a decrease in enzyme activity. This phenomenon creates a direct relationship between drug concentration in urine and enzyme activity. The enzyme G6PDH activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

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

Not Found

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

The DRI Ecstasy Enzyme Immunoassay was evaluated via a series of traditional laboratory studies. These studies included the performance characteristics of sensitivity, linearity, specificity, precision, and accuracy.
The assay showed good sensitivity with an LOD of 22 ng/mL.
Precision studies indicated good reproducibility of results at the critical points of the measurement range (distinguishing positive from negative interpretations), as dose %CVs for both total and within-run testing were below 2.5%.
The DRI Ecstasy Enzyme Immunoassay is linear between 375 and 625 ng/mL. The assay also shows good separation in the decision-making ranges between 375 and 625 ng/mL.
Accuracy studies showed good performance of the DRI Ecstasy Enzyme Immunoassay as compared to the GC/MS reference method. The %Agreement (Total) is 100%.
Specificity testing demonstrated that the DRI Ecstasy Enzyme Immunoassay is not affected by common endogenous substances, variations in urinary pH levels, structurally unrelated pharmaceutical compounds, or potentially cross-reacting compounds.

Key Metrics

Sensitivity: LOD of 22 ng/mL
Precision: dose %CVs for both total and within-run testing were below 2.5%, Percent dose CVs across 3 levels of ecstasy concentrations were

§ 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).

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AUG 2 7 2001

Image /page/0/Picture/1 description: The image shows the logo for Microgenics. The logo consists of a circular design on the left, resembling a sun or a stylized flower, with numerous small, dark, wedge-shaped elements arranged in concentric circles. To the right of this design is the word "microgenics" in a bold, sans-serif font, with a horizontal line underlining the text.

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K012 UU

Submitter Information (21 CFR 807.92(a)(1))

| Submitter: | Microgenics Corporation
46360 Fremont Boulevard
Fremont, CA 94538
phone: (510) 979-5150
fax: (510)-979-5455 |
|------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sherrie Rinne |

Regulatory Specialist

July 3, 2001 Summary date:

Name of Device and Classification (21 CFR 807.92(a)(2))

DRI® Ecstasy Enzyme Immunoassay Name (trade):

Ecstasy Enzyme Immunoassay Name (usual):

Amphetamines test system, 21 CFR 862.3100, Class II, DKZ (91) Classification:

Identification of Legally Marketed Predicate Device(s) (21 CFR 807,92 (a)(3))

DRI Ecstasy Enzyme Immunoassay is substantially equivalent to CEDIA DAU Amphetamines/Ecstasy Assay (Microgenics Corporation, Fremont, CA), cleared under premarket notification K010496

DRI Ecstasy Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, risk to the patient, and clinical performance.

Description of Device (21 CFR 807.92 (a)(4))

The DRI Ecstasy Assay is a liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies, which can detect ecstasy drugs in urine with minimal cross-reactivity to various amphetamine compounds. The assay is based on competition between a drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme, and free drug from the urine sample for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the specific antibody binds the drug labeled with G6PDH causing a decrease in enzyme activity. This phenomenon creates a direct relationship between drug concentration in urine and enzyme activity. The enzyme G6PDH activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

Microgenics Corporation

1

Intended Use (21 CFR 807.92 (a)(5))

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 500 ng/mL.

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.

Similarities to the Predicate(s) (21 CFR 807.92 (a)(6))

A summary table of the similarities and difference between DRI Ecstasy Enzyme Immunoassay and the predicate device follows.

Comparison Table:

| Device Name | CEDIA DAU
Amphetamines/Ecstasy Assay
(K010496) | DRI Ecstasy Enzyme Immunoassay
(new device) |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The CEDIA DAU Amphetamines / Ecstasy
Assay is a homogeneous enzyme
immunoassay for the in vitro qualitative or
semiquantitative assay of amphetamines in
human urine on automated clinical chemistry
analyzers. Measurements are used as an aid in
the detection of amphetamines use or
overdose. For use in clinical laboratories only.

CEDIA Amphetamines/Ecstasy is uniquely
designed to recognize samples that contain
any of the Ecstasy Drugs, a group of ring
substituted methylenedioxy analogues of
amphetamine including 3,4-
methylenedioxyamphetamine (MDA), 3,4-
methylenedioxymethamphetamine (MDMA)
and 3,4-methylenedioxyethylamphetamine
(MDEA).

This assay is intended for use on automated
clinical analyzers. 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) is the preferred confirmatory
method. Other chemical confirmation methods
are available. Clinical consideration and
professional judgement should be applied to
any drug of abuse test result, particularly when | 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 500 ng/mL.

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. |
| Device Name | CEDIA DAU
Amphetamines/Ecstasy Assay
(K010496) | DRI Ecstasy Enzyme Immunoassay
(new device) |
| Indications
for Use
(cont.) | preliminary positive results are used.
The CEDIA Amphetamines/ Ecstasy Assay
provides a choice of two cutoff levels: 500 and
1000 ng/mL The assay is appropriate for
testing under the Substance Abuse and Mental
health Services Administration (SAMHSA,
formerly NIDA) guidelines, which currently
recommends a cutoff of 1000 ng/mL | |
| Method
Principle | The assay uses recombinant DNA technology
to produce a unique homogeneous enzyme
immunoassay system. It is based on the
bacterial enzyme β-galactosidase, which has
been genetically engineered into two inactive
fragments. These fragments spontaneously
reassociate to form a fully active enzyme that,
in the assay format, cleaves a substrate,
generating a color change that can be
measured spectrophotometrically. | The assay uses specific antibodies,
which can detect ecstasy drugs in urine
with minimal cross-reactivity to
various amphetamine compounds. The
assay is based on competition between
a drug labeled with glucose-6-
phosphate dehydrogenase (G6PDH)
enzyme, and free drug from the urine
sample for a fixed amount of specific
antibody binding sites. In the absence
of free drug from the sample, the
specific antibody binds the drug
labeled with G6PDH causing a
decrease in enzyme activity. This
phenomenon creates a direct
relationship between drug
concentration in urine and enzyme
activity. The enzyme G6PDH activity
is determined spectrophotometrically at
340 nm by measuring its ability to
convert nicotinamide adenine
dinucleotide (NAD) to NADH. |
| Components | - Enzyme Acceptor Reagent

  • Enzyme Acceptor Buffer
  • Enzyme Donor Reagent
  • Enzyme Donor Buffer | - Antibody/Substrate Reagent
  • Enzyme Conjugate Reagent |
    | Risk to
    patient | In vitro device, positive results must be
    confirmed by GC/MS, or other method. | In vitro device, positive results must be
    confirmed by GC/MS, or other method. |
    | Clinical
    Performance | Accuracy: %Agreement against a GC/MS
    reference method was 95% (159 true positives,
    18 true negatives); | Accuracy: %Agreement against a
    GC/MS reference method was 100%
    (92 true positives, 18 true negatives); |
    | | Total Imprecision: Percent dose CVs across 6
    levels of amphetamines concentrations were
    between 7.8% and 9.2%. | Total Imprecision: Percent dose CVs
    across 3 levels of ecstasy
    concentrations were Trade/Device Name: DRI® Ecstasy Enzyme Immunoassy Regulation Number: 21 CFR 862.3100 Regulatory Class: II Product Code: DKZ Dated: July 3 2001 Received: July 6, 2001

Dear Ms. Rinne:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nouticate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (201) 59 m 1500 - 1000 - 1000 - 1000 - 1000 - 4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mornation on Jun 1000 consumer Assistance at its toll-free number (800) 638-2041 or 1401) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

6

STATEMENT OF INTENDED USE

510(K) Number (if known): _KO12110

Device Name: DRI® Ecstasy Enzyme Immunoassay

Indications for 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 500 ng/mL.

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 judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE AS NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use >> (Per 21 CFR 801.109) OR

Over-the-Counter Use

Kesia Alexander for Jean Cooper
(Division Sign-Off)

Laboratory Devices 510(k) Number

Microgenics Corporation DRI Ecstasy Enzyme Immunoassay Page 13 of 32