The RapidSense™ Drugs of Abuse Phencyclidine (PCP) 25 Device is a lateral flow competitive immunoassay intended for the qualitative detection for Phencyclidine in human urine at a cut-off concentration of 25 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 PCP cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with tests for PCP and cause false positive results.

Device Description

The RapidSense™ Drugs of Abuse Phencyclidine (PCP) 25 Device is an immunoassay based on the principle of competitive binding. Phencyclidine 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 coloredlatex particle, monoclonal antibody-based rapid test for the qualitative detection of Phencyclidine at a cut-off of 25 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

The provided 510(k) summary describes the RapidSense™ Drugs of Abuse Phencyclidine (PCP) 25 Device and a study conducted to demonstrate its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds (e.g., "must achieve >90% sensitivity"). Instead, it presents the device's performance metrics (agreement rates with GC/MS) and implicitly suggests that these results demonstrated "substantial equivalence" to the predicate device and the reference method. For the purpose of this table, I will use the reported agreement rates as the "reported performance" and infer that demonstrating these high levels of agreement was the implicit "acceptance criteria" for substantial equivalence.

Metric	Implicit Acceptance Criteria (Inferred from Study Conclusion)	Reported Device Performance (RapidSense™ vs. GC/MS)
Positive Agreement	High agreement with GC/MS (e.g., >90%)	96.6% (88.3 to 99.1% CI)
Negative Agreement	High agreement with GC/MS (e.g., >90%)	95.6% (85.2 to 98.8% CI)
Total Agreement	High agreement with GC/MS (e.g., >90%)	96.1% (90.4 to 98.5% CI)

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

Sample Size for the Test Set: 80 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 the country of origin is not specified, but given the manufacturer and consultant's addresses are in the US, it's highly likely to be from the United States.

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

The ground truth was established by laboratory analysis using Gas chromatography/mass spectrometry (GC/MS). This is an analytical chemical method, not reliant on expert human interpretation in the same way as, for example, a radiologist reading an image. Therefore, the concept of "number of experts" and "qualifications of those experts" as typically applied to clinical image interpretation or diagnosis by multiple clinicians does not directly apply here. The "experts" would be the trained laboratory personnel operating the GC/MS equipment and interpreting the results according to established protocols. No specific number or qualifications are given in the document, which is typical for objective analytical methods.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense for this type of study. The ground truth was established by GC/MS, which is an objective chemical analysis. The RapidSense™ device results were directly compared to these GC/MS results. There was no mention of multiple readings of the RapidSense™ device that required adjudication.

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

No, an MRMC comparative effectiveness study was not done. This study is for an in vitro diagnostic (IVD) device (a lateral flow immunoassay), not an AI-based diagnostic tool that assists human readers.

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

Yes, this study represents a standalone performance evaluation of the RapidSense™ device. The device itself (a test strip) generates a result (positive or negative read based on a colored line), and this result is directly compared to the GC/MS reference method. While healthcare professionals interpret the visual output, the study focuses on the accuracy of the device's output itself, independent of potential human interpretive errors influencing the device's intrinsic performance.

7. The Type of Ground Truth Used

The ground truth used was Gas chromatography/mass spectrometry (GC/MS) results. This is considered a gold standard analytical method for confirming the presence and concentration of drugs in urine.

8. The Sample Size for the Training Set

The document does not provide information regarding a training set. This is typical for traditional immunoassay devices, which are developed based on chemical and biological principles rather than machine learning models that require distinct training sets. The study described is entirely a performance validation on a "test set" or clinical sample set.

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

As no training set is mentioned or implied for the development of this device, this question is not applicable. The device's mechanism (competitive immunoassay with colored-latex particles) is based on established biochemical principles, not on learned patterns from a training dataset.

Summary

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Lo80431

Image /page/0/Picture/1 description: The image shows the logo for QuantRx Biomedical Corporation. The logo features a stylized "Q" above the company name, with the words "QuantRx" in a bold, sans-serif font. Below the company name, the words "Biomedical Corporation" are written in a smaller font size.

510(k) Summary

JAN - 8 2009

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:

December 9, 2008

DEVICE INFORMATION

Trade/Proprietary Name:

RapidSense™ Drugs of Abuse Phencyclidine (PCP) 25 device Common Name: Phencyclidine assay 21 CFR 862.3100 Class II Product Code: LCM

Intended Use:

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Product Description:

Predicate Device:

ACON PCP One Step Phencyclidine Test Strip & Test Device 510(k) Number K011730

Comparison to Predicate Device

Both the RapidSense™ Drugs of Abuse Phencyclidine (PCP) 25 device and the ACON PCP One Step Phencyclidine Test Device, cleared under K011730 have the indications for use and same cut-off of 25 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 Phencyclidine (PCP) 25 device differs from the ACON PCP One Step Phencyclidine 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 Phencyclidine (PCP) 25 Device was compared to the reference method of Gas chromatography/mass spectrometry (GC/MS) on 80 specimens previously collected from subjects presenting for drug testing by an external laboratory. Phencyclidine was quantified by GC/MS with a cut-off of 25 ng/mL as well as compared to the predicate device.

The results of the study were as follows:

RapidSense ™ Drugs of Abuse Phencyclidine (PCP) 25 Device compared to GC/MS.

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Positive Agreement: 56/58 = 96.6% (88.3 to 99.1%) Negative Agreement: 43/45 = 95.6% (85.2 to 98.8%) Total Agreement: 99/103 = 96.1% (90.4 to 98.5%) 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 Phencyclidine (25) device to the ACON PCP One Step Phencyclidine Test Device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is an eagle emblem.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

QuantRx BioMedical Corporation c/o Ms. Natalie J. Kennel Principal Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129

JAN - 8 2009

Re: K080431

Trade/Device Name: RapidSense™ Drugs of Abuse Phencyclidine (PCP) 25 Device Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Codes: LCM Dated: December 09, 2008 Received: December 11, 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, 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

יין

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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, permite 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 (301) 594-3084. 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 tollit the (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Corg C. He

Courtney C. Harper, Ph.D. Acting Director . Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indication for Use

510(k) Number (if known): K080431

Device Name: RapidSense™ Drugs of Abuse Phencyclidine (PCP) 25 Device

Indication For Use:

The RapidSense™ Drugs of Abuse Phencyclidine (PCP) 25 Device is a lateral flow competitive immunoassay intended for the qualitative detection for phencyclidine in human urine at a cut-off concentration of 25 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 PCP cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with tests for PCP 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) K000431

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Regulation Number and Section

N/A