DRI Ecstasy Urine Calibrators are human urine-based and ready to use. They are prepared by spiking negative urine matrix with known quantities of 3,4-methylenedioxymethamphetamine (MDMA). The DRI Ecstasy 500 ng/mL Calibrator is used as the qualitative cutoff reference for distinguishing "positive" from "negative" samples.

The DRI Ecstasy Calibrators available are as follows"

250 ng/mL Calibrator 500 ng/mL Calibrator 750 ng/mL Calibrator 1000 ng/mL Calibrator

AI/ML Overview

The provided text describes the DRI Ecstasy Urine Calibrators and its clearance via a 510(k) submission. It briefly mentions "traditional laboratory studies" for performance characteristics but lacks the detailed information required to fill out many of the requested fields definitively.

Here's an analysis based on the provided text, with N/A for information not present:

1. A table of acceptance criteria and the reported device performance

The document states that "The DRI Ecstasy Urine Calibrators were evaluated via a series of traditional laboratory studies. These studies included the performance characteristics of precision, stability, and accuracy." However, it does not provide specific acceptance criteria or the reported performance values for these characteristics.

Acceptance Criteria	Reported Device Performance
N/A	N/A
(Specific quantitative thresholds for precision, stability, and accuracy are not provided in the document.)	(Actual numerical results for precision, stability, and accuracy are not provided in the document.)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for any test sets or the provenance of the data. It only generally refers to "traditional laboratory studies."

Sample Size (Test Set): N/A
Data Provenance: N/A (implied to be internal laboratory studies, likely U.S.-based given the manufacturer's location, but not explicitly stated).
Retrospective or Prospective: N/A

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As this device is a calibrator for an immunoassay, the "ground truth" would almost certainly be established by the known concentrations of 3,4-methylenedioxymethamphetamine (MDMA) spiked into the negative urine matrix during the manufacturing process of the calibrators. This does not involve human experts in the same way as, for example, image interpretation.

Number of Experts: N/A (Ground truth established by manufacturing specifications/spiking)
Qualifications of Experts: N/A

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as ground truth is based on known concentrations, not expert interpretation requiring adjudication.

Adjudication Method: N/A

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is a calibrator device for an immunoassay, not an AI-powered diagnostic device. Therefore, MRMC studies are not relevant.

MRMC Study: No
Effect Size: N/A

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is a calibrator device, not an algorithm. Therefore, standalone algorithm performance is not applicable.

Standalone Study: No

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the calibrators is the known, spiked concentrations of 3,4-methylenedioxymethamphetamine (MDMA) in the negative urine matrix.

Type of Ground Truth: Known analytical concentrations / manufacturing specifications (spiked concentrations).

8. The sample size for the training set

This is a calibrator device, not a machine learning algorithm that requires a "training set" in the conventional sense. The "development" or "manufacturing" process would involve analytical chemistry and quality control, not machine learning model training.

Sample Size (Training Set): N/A

9. How the ground truth for the training set was established

Again, as a calibrator, the concept of a "training set" with established ground truth for an algorithm is not applicable. The known concentrations of MDMA for the calibrators are established during their production.

How Ground Truth for Training Set was Established: N/A (Ground truth is the known spiked concentration of MDMA during manufacturing).

Summary

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KO12109

AUG 2 7 2001

Image /page/0/Picture/2 description: The image shows the logo for "microgenics". The logo features a circular design on the left, composed of small, petal-like shapes arranged in a spiral pattern. To the right of the circular design is the word "microgenics" in a bold, sans-serif font. A horizontal line underlines the word, adding emphasis to the brand name.

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: K01

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

Submitter:	Microgenics Corporation46360 Fremont BoulevardFremont, CA 94538phone: (510) 979-5150fax: (510) 979-5455
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Sherric Rinne Contact: Regulatory Specialist

July 3, 2001 Summary date:

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

Name (trade):	DRI ECSTASY URINE CALIBRATORS®
Name (usual):	Ecstasy Urine Calibrators

Calibrator, Drug Specific; 21 CFR 862.3200, Class II, DJL (91) Classification:

Identification of Legally Marketed Predicate Device(s) (21 CFR 807.92 (a)(3))

DRI Ecstasy Urine Calibrators are substantially equivalent to DRI Multi-Drug Calibrators (Microgenics Corporation, Fremont, CA), cleared under premarket notification K983159

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

The DRI Ecstasy Calibrators available are as follows"

250 ng/mL Calibrator 500 ng/mL Calibrator 750 ng/mL Calibrator 1000 ng/mL Calibrator

Intended Use (21 CFR 807,92 (a)(5))

The DRI Ecstasy urine Calibrators are intended for the calibration of the DRI Ecstasy Immunoassay

Microgenics Corporation

48360 Fremont Boulevard, Fremont, CA 94538 USA O Tel: (510) 979-5000 O Fax: (510) 979-5002 Technical Service/Customer Service (800) 232-3342

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Similarities to the Predicate(s) (21 CFR 807,92 (a)(6))

The DRI Ecstasy Urine Calibrators are similar in intended use, matrix, and performance to the DRI Multi-Drug Urine Calibrators.

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

The DRI Ecstasy Urine Calibrators were evaluated via a series of traditional laboratory studies. These studies included the performance characteristics of precision, stability, and accuracy.

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.

The DRI Ecstasy urine calibrators were evaluated via a series of traditional laboratory studies. These studies included the performance characteristics of precision, stability, and accuracy.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design of an eagle with its wings spread, represented by three curved lines. The eagle design is black, and the text is also in black.

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 94538

Re: K012109

Trade/Device Name: DRI® Ecstasy Urine Calibrators Regulation Number: 21 CFR 862.3200 Regulatory Class: II Product Code: DLJ 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 predicate 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, please contact the Office of Compliance at (301) 594-4639. 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 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/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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): __ KO12 109 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: DRI® Ecstasy Urine Calibrators

Indications for Use:

The DRI® Ecstasy Urine Calibrators are intended for the calibration of the DRI Ecstasy Immunoassay.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-the-Counter Use	__
(Per 21 CFR 801.109)

	Kesia Alexander for Sean Cupit (Division Sign-Off)
--	--------------------------------------------------------------------------------------------------

Division of Clinical Laboratory Devices

Microgenics Corporation	510(k) Number	K012109	Page 13 of 18
DRI Ecstasy Urine Calibrators

Regulation Number and Section

§ 862.3200 Clinical toxicology calibrator.

(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). 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.