The RapidSense™ Drugs of Abuse Cocaine (COC) 300 Device is a lateral flow competitive immunoassay intended for the qualitative detection for the cocaine metabolite, benzoylecgonine, in human urine at a cut-off concentration of 300 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 cocaine metabolite specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method.

Device Description

The RapidSense™ Drugs of Abuse Cocaine (COC) 300 Device is an immunoassay based on the principle of competitive binding. The cocaine metabolite, benzoylecgonine, 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 the cocaine metabolite at a cut-off of 300 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 an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

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

Acceptance Criteria (Implied)	Reported Device Performance (RapidSense™ vs. GC/MS)
Sufficient positive agreement with GC/MS	91.1% (41/45) (95% CI: 79.3% - 96.5%)
Sufficient negative agreement with GC/MS	95.2% (40/42) (95% CI: 84.2% - 98.7%)
Sufficient total agreement with GC/MS	93.1% (81/87) (95% CI: 85.8% - 96.8%)
Similar performance to predicate device	Reported as "similar performance"

Note: The document doesn't explicitly state numerical acceptance criteria thresholds. Instead, it presents the performance and concludes that these results "demonstrate the substantial equivalence." The implied acceptance criteria are that the device's performance should be high enough to be considered substantially equivalent to a legally marketed predicate device and to the recognized reference method (GC/MS).

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: 85 specimens
Data Provenance: "previously collected from subjects presenting for drug testing by an external laboratory." This indicates the data is retrospective. The country of origin is not explicitly stated, but the submission is to the US FDA, suggesting it's likely from the US or a region with comparable clinical practices.

3. 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 document. The ground truth for the test set (accuracy study) was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical chemical method, not human expert consensus.

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

This information is not applicable/provided. The ground truth for the test set was established by GC/MS, an objective chemical analysis, not human interpretation requiring 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:

This is not applicable. This device is an in-vitro diagnostic (IVD) device (a laboratory test), not an imaging or interpretation device that would involve human readers or AI assistance in the way an MRMC study typically assesses. The device provides a qualitative "positive" or "negative" result.

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

Yes, the accuracy study comparing the RapidSense™ device to GC/MS is a standalone performance study. The device itself, without human interpretation of complex images or data, provides the result directly from the urine sample. Human professionals simply read the yes/no result from the device.

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

The ground truth used for the accuracy study was Gas Chromatography/Mass Spectrometry (GC/MS). This is considered a gold standard analytical method for confirming the presence and concentration of drugs and their metabolites in biological samples.

8. The sample size for the training set:

This information is not provided in the document. As an immunoassay, the "training set" concept (as understood for machine learning algorithms) doesn't directly apply in the same way. The device's performance relies on its physical and chemical design, manufacturing, and calibration, rather than an algorithm trained on a dataset.

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

This information is not provided and is not directly applicable in the sense of a machine learning training set. The "ground truth" for the development and calibration of such an immunoassay would typically involve testing known positive and negative samples, as well as samples spiked with known concentrations of the analyte, to optimize the assay's sensitivity and specificity around the specified cut-off. This process isn't detailed in the 510(k) summary.

Summary

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510(k) Summary K080436

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Contact Person:

Manufacturer:

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@nikconsulting.com
QuantRx Biomedical Corporation

5920 NE 112th Ave Portland, OR 97220

Feb. 6, 2009 Date Prepared:

DEVICE INFORMATION

Trade/Proprietary Name:

RapidSense™ Drugs of Abuse Cocaine (COC) 300 device Common Name: Cocaine & Cocaine metabolites Enzyme Immunoassay 21 CFR 862.3250 Class II Product Code: DIO

Intended Use:

The RapidSense™ Drugs of Abuse Cocaine (COC) 300 Device is a lateral flow competitive immunoassay intended for the qualitative detection for cocaine metabolite, Benzoylecgonine, in human urine at a cut-off concentration of 300 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For In Vitro Diagnostic Use.

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Positive Agreement: 41/45 = 91.1% (79.3 to 96.5%) Negative Agreement: 40/42 = 95.2% (84.2 to 98.7%) Total Agreement: 81/87= 93.1% (85.8 to 96.8%) 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 Cocaine (300) device to the ACON COC One Step Cocaine Test Device.

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Product Description:

Predicate Device:

ACON COC One Step Test Strip & Test Device 510(k) Number K010841

Comparison to Predicate Device

Both the RapidSense™ Drugs of Abuse Cocaine (COC) 300 device and the ACON COC One Step Cocaine Test Device, cleared under K010841 have the indications for use and same cut-off of 300 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 Cocaine (COC) 300 device differs from the ACON COC One Step Cocaine 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 Cocaine (COC) 300 Device was compared to the reference method of Gas chromatography/mass spectrometry (GC/MS) on 85 specimens previously collected from subjects presenting for drug testing by an external laboratory. The cocaine metabolite, benzoylecgonine, was quantified by GC/MS with a cut-off of 300 ng/mL as well as compared to the predicate device.

The results of the study were as follows:

RapidSense ™ Drugs of Abuse Cocaine (COC) 300 Device compared to GC/MS.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 an abstract image of an eagle with three stripes representing its wings.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

FEB 1 1 2009

Re: K080436

Trade/Device Name: RapidSense™ Drugs of Abuse Cocaine (COC) 300 Device Regulation Number: 21 CFR 862.3250

Regulation Name: Cocaine and cocaine metabolite test system. Regulatory Class: Class II

Product Code: DIO Dated: February 06, 2009 Received: February 09, 2009

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 (OS) regulation (21 CFR Part 820).

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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, 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 (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 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.

Coy C. Ht.

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): K080436

Device Name: RapidSense™ Drugs of Abuse Cocaine (COC) 300 Device

Indication For 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.

Prescription Use X (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)

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

And/Or

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

Vicki May

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K080436

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).