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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the DRI® Ecstasy Enzyme Immunoassay, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of predefined thresholds that the device must meet to be approved. Instead, it presents the performance characteristics of the device without directly comparing them to a pre-stated pass/fail benchmark within the document. However, we can infer the reported performance that was deemed acceptable for substantial equivalence.

Performance Characteristic	Reported Device Performance (DRI Ecstasy Enzyme Immunoassay)
Sensitivity	LOD of 22 ng/mL
Precision	Dose %CVs for both total and within-run testing were < 2.5%
Linearity	Linear between 375 and 625 ng/mL
Accuracy	100% Agreement (Total) against GC/MS reference method
Specificity	Not affected by common endogenous substances, variations in urinary pH levels, structurally unrelated pharmaceutical compounds, or potentially cross-reacting compounds.

Comparison to Predicate Device (CEDIA DAU Amphetamines/Ecstasy Assay):

Performance Characteristic	Predicate Device Performance (K010496)	New Device Performance (DRI Ecstasy Enzyme Immunoassay)
Accuracy	95% Agreement against GC/MS reference method (159 true positives, 18 true negatives)	100% Agreement against GC/MS reference method (92 true positives, 18 true negatives)
Total Imprecision	Percent dose CVs across 6 levels of amphetamines concentrations were between 7.8% and 9.2%.	Percent dose CVs across 3 levels of ecstasy concentrations were <2.5%.

2. Sample Size Used for the Test Set and Data Provenance

The document provides limited detail on specific sample sizes for all tests.

Accuracy Test Set:
- New Device: 92 true positives, 18 true negatives. This indicates a total of 110 samples were used in the accuracy study for the DRI Ecstasy Enzyme Immunoassay.
- Predicate Device (for comparison): 159 true positives, 18 true negatives. This indicates a total of 177 samples were used in the accuracy study for the predicate device.
Other tests (sensitivity, linearity, specificity, precision): The specific sample sizes are not explicitly stated.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It refers to them as "traditional laboratory studies."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The ground truth for the test set was established using Gas Chromatography/Mass Spectrometry (GC/MS).
The document does not mention the use of human experts or their qualifications for establishing the ground truth; GC/MS is described as the "preferred confirmatory method" and the reference standard.

4. Adjudication Method

Since the ground truth was established by GC/MS (a definitive laboratory method), there was no mention of an adjudication method involving human readers for the test set. The GC/MS results served as the objective reference.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this document. This device is an in-vitro diagnostic assay, not an imaging or diagnostic AI tool that would typically involve human readers interpreting results with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the performance data presented (sensitivity, precision, linearity, accuracy, specificity) represents the standalone performance of the DRI Ecstasy Enzyme Immunoassay itself. It evaluates the assay's ability to detect ecstasy drugs in urine based on its chemical reactions and spectrophotometric measurements, without human interpretation other than reading the instrument's output. The document explicitly states that the assay "provides only a preliminary analytical test result" and "a more specific alternate chemical method must be used in order to obtain a confirmed analytical result" (GC/MS). This reinforces that the assay's performance is being assessed as an initial screening tool, independent of human interpretive steps for confirmation.

7. Type of Ground Truth Used

The type of ground truth used was GC/MS (Gas Chromatography/Mass Spectrometry), which is a highly reliable and definitive analytical method for confirming the presence and concentration of substances like drugs.

8. Sample Size for the Training Set

The document does not provide any information about a "training set" or its sample size. This is typical for traditional enzyme immunoassays, where the assay itself is developed and optimized through chemical and biochemical engineering, rather than machine learning models that require distinct training sets.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for this type of device, no information is provided on how its ground truth would have been established. The device development process would have involved internal validation and optimization against known standards and samples, but these are not referred to as a "training set" in the context of this submission.

Summary

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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 Corporation46360 Fremont BoulevardFremont, CA 94538phone: (510) 979-5150fax: (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))

Microgenics Corporation

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

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 DAUAmphetamines/Ecstasy Assay(K010496)	DRI Ecstasy Enzyme Immunoassay(new device)
Indications for Use	The CEDIA DAU Amphetamines / EcstasyAssay is a homogeneous enzymeimmunoassay for the in vitro qualitative orsemiquantitative assay of amphetamines inhuman urine on automated clinical chemistryanalyzers. Measurements are used as an aid inthe detection of amphetamines use oroverdose. For use in clinical laboratories only.CEDIA Amphetamines/Ecstasy is uniquelydesigned to recognize samples that containany of the Ecstasy Drugs, a group of ringsubstituted methylenedioxy analogues ofamphetamine including 3,4-methylenedioxyamphetamine (MDA), 3,4-methylenedioxymethamphetamine (MDMA)and 3,4-methylenedioxyethylamphetamine(MDEA).This assay is intended for use on automatedclinical analyzers. The assay provides only apreliminary analytical test result. A morespecific alternative chemical method must beused to obtain a confirmed analytical result.Gas chromatography / mass spectrometry(GC/MS) is the preferred confirmatorymethod. Other chemical confirmation methodsare available. Clinical consideration andprofessional judgement should be applied toany drug of abuse test result, particularly when	The DRI Ecstasy EnzymeImmunoassay is a homogeneousenzyme immunoassay intended for thequalitative or semiquantitativedetermination of ecstasy drugs inhuman urine. The assay provides asimple and rapid analytical screeningprocedure for detecting ecstasy drugs ata Cutoff level of 500 ng/mL.This assay provides only a preliminaryanalytical test result. A more specificalternate chemical method must beused in order to obtain a confirmedanalytical result. Gaschromatography/mass spectrometry(GC/MS) is the preferred confirmatorymethod. Clinical consideration andprofessional judgment should beapplied to any drug of abuse test result,particularly when preliminary positiveresults are used.
Device Name	CEDIA DAUAmphetamines/Ecstasy Assay(K010496)	DRI Ecstasy Enzyme Immunoassay(new device)
Indicationsfor Use(cont.)	preliminary positive results are used.The CEDIA Amphetamines/ Ecstasy Assayprovides a choice of two cutoff levels: 500 and1000 ng/mL The assay is appropriate fortesting under the Substance Abuse and Mentalhealth Services Administration (SAMHSA,formerly NIDA) guidelines, which currentlyrecommends a cutoff of 1000 ng/mL
MethodPrinciple	The assay uses recombinant DNA technologyto produce a unique homogeneous enzymeimmunoassay system. It is based on thebacterial enzyme β-galactosidase, which hasbeen genetically engineered into two inactivefragments. These fragments spontaneouslyreassociate to form a fully active enzyme that,in the assay format, cleaves a substrate,generating a color change that can bemeasured spectrophotometrically.	The assay uses specific antibodies,which can detect ecstasy drugs in urinewith minimal cross-reactivity tovarious amphetamine compounds. Theassay is based on competition betweena drug labeled with glucose-6-phosphate dehydrogenase (G6PDH)enzyme, and free drug from the urinesample for a fixed amount of specificantibody binding sites. In the absenceof free drug from the sample, thespecific antibody binds the druglabeled with G6PDH causing adecrease in enzyme activity. Thisphenomenon creates a directrelationship between drugconcentration in urine and enzymeactivity. The enzyme G6PDH activityis determined spectrophotometrically at340 nm by measuring its ability toconvert nicotinamide adeninedinucleotide (NAD) to NADH.
Components	- Enzyme Acceptor Reagent- Enzyme Acceptor Buffer- Enzyme Donor Reagent- Enzyme Donor Buffer	- Antibody/Substrate Reagent- Enzyme Conjugate Reagent
Risk topatient	In vitro device, positive results must beconfirmed by GC/MS, or other method.	In vitro device, positive results must beconfirmed by GC/MS, or other method.
ClinicalPerformance	Accuracy: %Agreement against a GC/MSreference method was 95% (159 true positives,18 true negatives);	Accuracy: %Agreement against aGC/MS reference method was 100%(92 true positives, 18 true negatives);
	Total Imprecision: Percent dose CVs across 6levels of amphetamines concentrations werebetween 7.8% and 9.2%.	Total Imprecision: Percent dose CVsacross 3 levels of ecstasyconcentrations were <2.5%.

DRI Ecstasy Enzyme Immunoassay vs CEDIA DAU Amphetamines/Ecstasy Assay

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Brief Discussion of Nonclinical/Clinical Data (21 CFR 807.92(b)(1, 2))

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.

Performance Data - Conclusions (21 CFR 807.92 (b)(3))

The DRI Ecstasy Enzyme Immunoassay has been shown to be substantially equivalent to the predicate device, and safe and effective for its intended use.

Conclusions

The DRI Ecstasy Enzyme Immunoasay 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.

The DRI Ecstasy Enzyme Immunoassay is linear between 375 and 625 ng/mL. The assay shows good separation in the decision-making ranges between 375 and 625 ng/mL.

Accuracy studies showed excellent performance of the DRI Ecstasy Enzyme Immunoassay as compared to the GC/MS reference method. The %Agreement (Total) is 100%.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three wavy lines representing snakes intertwined around a staff.

AUG 2 7 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sherrie Gene Rinne Regulatory Specialist Microgenics Corporation 46360 Fremont Boulevard Fremont, CA 95438

Re: K012110

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

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STATEMENT OF INTENDED USE

510(K) Number (if known): _KO12110

Device Name: DRI® Ecstasy Enzyme Immunoassay

Indications for Use:

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

Regulation Number and Section

§ 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).