(107 days)
This device is a one-step intended to provide qualitative rapid detection of methylenedioxymethamphetamine (MDMA, or Ecstasy, XTC) in human urine at a cut-off concentration of 500ng/ml. It is for health care professional use only.
This test 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.
A one-step lateral flow chromatographic immunoassay. The test strip in the device includes 1) a conjugate pad containing colloidal gold coupled with mouse anti-MDMA antibody; 2) nitrocellulose membrane containing a test line (T line) coated with MEMA-BSA and a control line (C line) coated with Goat anti mouse antibody.
Here's a summary of the acceptance criteria and the study details for the Instant-View™ MDMA (Ecstasy, XTC) Urine Test, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy (Overall Agreement) | 97.5% agreement with MDMA GC/MS data. |
| Accuracy (Agreement at levels below 75% of cutoff and above cutoff) | 100% agreement with MDMA GC/MS data. |
| Reproducibility | 97.5% agreement across four evaluation sites. |
| Specificity (Non-cross-reactivity with other compounds at 100 µg/ml) | Most structurally related compounds showed no cross-reactivity or interference. |
| Specificity (Cross-reactivity with structurally related amphetamines) | Methylenedioxyampphetamine (MDA) at 2000 ng/ml and Methylenedioxyethylamphetamine (MDEA) at 1000 ng/ml showed cross-reactivity. |
| Cut-off Concentration | Qualitative detection at a cut-off of 500 ng/ml. |
Study Details
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1. Sample size used for the test set and the data provenance:
- Sample Size: 80 clinical urine specimens.
- Data Provenance: Retrospective, with no specific country of origin mentioned beyond "clinical urine specimens."
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2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) data, which is an analytical method, not directly dependent on expert interpretation in the same way as, for example, reading a medical image.
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3. Adjudication method for the test set:
- None stated directly for test set results. The comparison was against objective GC/MS data. Discrepancies were noted but no human adjudication process for those discrepancies is described.
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4. 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:
- No. This device is a rapid diagnostic immunoassay, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not applicable.
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5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, for the accuracy study. The device itself produced results that were then compared to the GC/MS ground truth. While it's a qualitative test, the performance metrics (agreement percentage) reflect the device's standalone capability.
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6. The type of ground truth used:
- Pathology/Outcomes Data: The ground truth was established using Gas Chromatography/Mass Spectrometry (GC/MS) data. This is a highly accurate and commonly accepted confirmatory method for drug testing, often considered the gold standard.
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7. The sample size for the training set:
- Not explicitly stated. The document describes "accuracy studies" and "reproducibility studies" but does not differentiate a specific "training set" for the device, as it is a lateral flow immunoassay that operates based on a fixed chemical design, not a machine learning algorithm.
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8. How the ground truth for the training set was established:
- Not applicable for a training set as the device is a chemical immunoassay, not an algorithm that undergoes a training phase with labeled data in the conventional sense of AI. The performance validation was against GC/MS data on clinical specimens.
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NOV 1 3 2002
510(k) Summary of Safety and Effectiveness as Required by 21 CFR 807.92
| Submitter andmanufacture | Name: Alfa Scientific Designs, Inc.Address: 12330 Stowe DrivePoway, CA 92064Contact Person: Naishu Wang, MD, Ph.D.Telephone: (858) 513-3888 x 308Fax: (858) 513-8388E-mail: wnss@alfascientific.com |
|---|---|
| Device Name | Trade Name: Instant-View™ MDMA (Ecstasy, XTC) Urine TestCommon Name: Immunoassay, MDMA Urine TestClassification: Amphetamine Test System (21 CFR 862.3100)Class II |
| Date of SummaryPreparation | October 28, 2002 |
| Predicate Device | Microgenics A-Sure™ Ecstasy Drug Screen Test made byApplied Biotech, Inc. K011133 |
| Device Description | A one-step lateral flow chromatographic immunoassay. Thetest strip in the device includes 1) a conjugate pad containingcolloidal gold coupled with mouse anti-MDMA antibody; 2)nitrocellulose membrane containing a test line (T line) coatedwith MEMA-BSA and a control line (C line) coated with Goatanti mouse antibody. |
| Similarity to thePredicate Device | • Both are one-step later-flow chromatographic immunoassay.• Both are used for qualitative detection of MDMA (Ecstasy, XTC) at a cutoff of 500 ng/ml.• Both are based on the similar mechanism• Both use a C line as built-in control to indicate that anappropriate volume of sample is applied and the deviceperforms properly.• Both provide a preliminary result and a positive result needsto be confirmed with a more solid reference method. |
| Intended Use | This device is a one-step immunoassay intended to providequalitative detection of methylenedioxymeth-amphetamine (MDMA, also Ecstasy, or XTC) in human urineat a cutoff concentration of 500ng/ml. It is for health careprofessional use only. |
| Accuracy studies | Eighty clinical urine specimens with MDMA GC/MS data wasevaluated with the Instant-View™ MDMA (Ecstasy, XTC) UrineTest. The results from the Instant-View™ MDMA (Ecstasy, XTC)Urine Test agreed 100% with the MDMA GC/MS data of theclinical specimens at the level below 75% of the cutoff andabove the cutoff. Two (2) discrepancies were observed on thespecimens with the MDMA GC/MS data between the cutofflevel and the level of 75% cutoff.The overall agreement is 97.5%. |
| Reproducibilitystudies | The reproducibility of this device was studied outside of Alfa atthree Physician's Office Laboratories (POL) and one referencelaboratory. Evaluations were performed by personnel withdiverse educational backgrounds and working experiences. Theresults from the four evaluation sites agreed 97.5%, indicatinga high reproducibility of this device. |
| Specificity studies | Two of the structurally related compounds showed crossreactivity with this device: methylenedioxyampphetamine(MDA) at 2000 ng/ml and methylenedioxyethylamphetamine(MDEA) at 1000 ng/ml. Other structurally related compoundstested did not show cross reactivity or interference with thisdevice at the concentration of 100 µg/ml. |
| Conclusion | The results of accuracy, reproducibility, and specificity studiesdemonstrate that the Instant-View™ MDMA (Ecstasy, XTC)Urine Test is substantially equivalent to the legally marketedtest. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus with three intertwined snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo in a circular fashion.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 3 2002
Naishu Wang, M.D., Ph.D. . President Alfa Scientific Designs, Inc. 12330 Stowe Drive Poway, CA 92064
Re: K022501
Trade/Device Name: Instant-View™ MDMA (Ecstasy, XTC) Urine Test Regulation Number: 21 CFR 862.3610 Regulation Name: Methanphetamine test system Regulatory Class: Class II Product Code: DJC Dated: October 28, 2002 Received: October 31, 2002
Dear Dr. Wang:
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, 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 (PMA), 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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 i 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 Butman
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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510 (K) NUMBER (IF KNOWN) :
DEVICE NAME : Instant-View" MDMA (Ecstasy, XTC) Urine Test
INDICATIONS FOR USE:
This device is a one-step intended to provide qualitative rapid detection of methylenedioxymethamphetamine (MDMA, or Ecstasy, XTC) in human urine at a cut-off concentration of 500ng/ml. It is for health care professional use only.
This test 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED . )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022501
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).