The RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 Device is a lateral flow competitive immunoassay intended for the qualitative detection of Methamphetamine in human urine at a cut-off concentration of 1000 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For in vitro diagnostic use.

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. Tests for methamphetamine cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with tests for methamphetamine and cause false positive results.

Device Description

The RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 Device is an immunoassay based on the principle of competitive binding. Methamphetamine which may be present in the urine specimen competes against its respective drug conjugate for binding sites on the specific antibody. The assay is a colored-latex particle, monoclonal antibody-based rapid test for the qualitative detection of Methamphetamine at a cut-off of 1000 ng/mL. The test utilizes the QuantRx patented, one step positive read, competitive immunoassay technology.

In the absence of the drug in the urine or if the amount of drug is below cut-off level, the visible test line zone (T) will show a clean negative (no signal on the test band). Drug positive specimens show a blue line in the visible test line zone (T). As an internal procedural control, a red control line appears in the control region (C) to verify that sufficient volume of sample was added and proper flow was obtained. The control line should always appear regardless of the presence of the drug if the assay has been performed properly.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a predefined numerical target for sensitivity and specificity. Instead, the study aims to demonstrate substantial equivalence to a predicate device (ACON mAMP One Step Methamphetamine Test Strip & Test Device, K011672). The performance metrics presented are the direct results of this comparative study. Therefore, the "acceptance criteria" can be inferred to be a level of agreement with the reference method and comparable performance to the predicate device.

Performance Metric	Reported Device Performance (RapidSense™ vs. GC/MS)
Positive Agreement	75.0% (33/44) [95% CI: 60.6% to 85.4%]
Negative Agreement	100% (40/40) [95% CI: 91.2% to 100.0%]
Total Agreement	86.9% (73/84) [95% CI: 78.1% to 92.5%]
Comparative Performance	Showed "similar performance" to the predicate device when compared to GC/MS.

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

Sample Size: 84 specimens
Data Provenance: The specimens were "previously collected from subjects presenting for drug testing by an external laboratory." This indicates the data is retrospective and likely originated from a clinical setting where drug testing is performed. The specific country of origin is not explicitly stated but is implied to be within the scope of the "external laboratory."

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

The ground truth was established by Gas chromatography/mass spectrometry (GC/MS), which is an analytical chemical method. Therefore, the "experts" in this context would be the specialized laboratory personnel or analytical chemists who performed and interpreted the GC/MS analysis. The document does not specify the number of individuals involved in performing the GC/MS or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

There was no human "adjudication method" in the sense of multiple human readers independently assessing the results and then resolving discrepancies. The device's results were directly compared against the GC/MS results, which served as the definitive ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study focused on the standalone performance of the RapidSense™ device against a gold standard (GC/MS) and a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 device itself is a qualitative immunoassay that provides a visual end point. The reported results (positive, negative, total agreement) are based on the direct interpretation of the device's output, without human-in-the-loop assistance for the device's reading itself. (Human technicians would apply the sample and read the results, but it's the device's intrinsic performance being measured).

7. The Type of Ground Truth Used

The type of ground truth used was analytical/confirmatory method data, specifically Gas chromatography/mass spectrometry (GC/MS). GC/MS is widely considered the gold standard for confirming drug presence and concentration.

8. The Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. This is typical for immunoassay devices, where the "training" (development and optimization) of the assay components and format is usually an internal process that occurs before formal validation studies. The reported study focuses on the validation of the finalized device.

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

As no training set information is provided, there is no detail on how ground truth for any potential training set was established.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for QuantRx Biomedical Corporation. The logo features a stylized letter "Q" above the company name. The letter "Q" is designed with a curved line forming the body and a horizontal line extending from the right side. Below the "Q" is the word "QuantRx" in a bold, sans-serif font, with the registered trademark symbol to the right. Underneath "QuantRx" is the text "BIOMEDICAL CORPORATION" in a smaller, sans-serif font.

K080455

DEC 3 1 2008

510(k) Summary

Manufacturer: QuantRx Biomedical Corporation 5920 NE 112th Ave Portland, OR 97220

Contact Person: Ms. Natalie J. Kennel Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 Phone: (858) 705-0350 Fax: (858) 764-9739 email: NKennel@njkconsulting.com

Date Prepared: Dec. 23, 2008

DEVICE INFORMATION

Trade/Proprietary Name; RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 device Common Name: Methamphetamine assay 21 CFR 862.3610 Class II Product Code: LAF

Intended Use:

The RapidSense™ Drugs of Abuse Methamphetamine (MFT) 1000 Device is a lateral flow competitive immunoassay intended for the qualitative detection of Methamphetamine in human urine at a cut-off concentration of 1000 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For in vitro diagnostic use.

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Product Description:

Predicate Device:

ACON mAMP One Step Methamphetamine Test Strip & Test Device 510(k) Number K011672

Comparison to Predicate Device

Both the RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 device and the ACON mAMP One Step Methamphetamine Test Device, cleared under K011672 have the indications for use and same cut-off of 1000 ng/mL. Both assays are lateral flow competitive immunoassays which provide a visual qualitative end point. Both assays are intended as a screening method that provides a preliminary test result.

The RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 device differs from the ACON mAMP One Step Methamphetamine Test Device in that the RapidSense™ device is a positive read test and the ACON device is a negative read test.

Summary of Safety and Effectiveness Data:

Accuracy:

The RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 Device was compared to the reference method of Gas chromatography/mass spectrometry (GC/MS) on 84 specimens previously collected from subjects presenting for drug testing by an external laboratory. Methamphetamine was quantified by GC/MS with a cut-off of 1000 ng/mL as well as compared to the predicate device.

The results of the study were as follows:

RapidSense TM Drugs of Abuse Methamphetamine (MET) 1000 Device compared to GC/MS.

Positive Agreement: 33/44 = 75.0% (60.6 to 85.4%*)

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Negative Agreement: 40/40 =100% (91.2 to 100.0%) Total Agreement: 73/84 = 86.9% (78.1 to 92.5%) * 95% Confidence intervals

The results of the predicate device to GCMS showed similar performance.

Conclusion:

These studies demonstrate the substantial equivalence of the RapidSense™ Drugs of Abuse Methamphetamine (1000) device to the ACON mAMP One Step Methamphetamine Test Device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Quantrx Biomedical Corporation c/o Natalic J Kennel NJK & Associates 13721 Via Tres Vista San Diego, CA 92129

DEC 3 1 2008

Rc: K080455

Trade/Device Name: Rapidsense drugs of abuse methamphetamine (met) 1000 device, model 900-0050 Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Codes: LAF Dated: December 23, 2008 Received: December 24, 2008

Dear Ms. Kennel:

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, isting of devices, good manufacturing practice, labeling, and prohibitions against misburanding 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Degister.

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 Parts 801 and 809); and good manufacturing practic f requirements as set forth in the quality systems (QS) regulation (21 CFR Party 200).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): K080455

Device Name: RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 Device

Indication For Use:

The RapidSense™ Drugs of Abuse Methamphetamine (MET) 1000 Device is a lateral flow competitive immunoassay intended for the qualitative detection of methamphetamine in human urine at a cut-off concentration of 1000 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For in vitro diagnostic use.

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. Tests for methamphetamine cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may iote ferge with tests for methamphetamine and cause false positive results.

Prescription Use X

And/Or

Over the Counter Use

(21 CFR Part 801 Subpart D) Subpart C)

(21 CFR Part 801

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 4080455

Regulation Number and Section

§ 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).