(358 days)
Not Found
No
The device description and performance studies indicate a standard lateral flow immunoassay, with no mention of AI or ML technologies.
No
The device is an in vitro diagnostic immunoassay for qualitative detection of a cocaine metabolite in urine, not a device used for therapy.
Yes
The "Intended Use / Indications for Use" section states: "For In Vitro Diagnostic Use." This directly indicates it is a diagnostic device, specifically for the qualitative detection of a cocaine metabolite in human urine.
No
The device description clearly describes a physical lateral flow immunoassay device that detects substances in urine. It is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use."
- Nature of the Test: The device is a lateral flow immunoassay intended for the qualitative detection of a substance (cocaine metabolite) in a human specimen (urine). This is a classic example of an in vitro diagnostic test, as it analyzes a sample taken from the body outside of the body itself.
- Intended User and Setting: The device is intended for use in "professional laboratories by healthcare professionals," which is a typical setting for IVD use.
N/A
Intended Use / Indications for 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.
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.
Product codes
DIO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional laboratories by healthcare professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies
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.
Results:
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.
These studies demonstrate the substantial equivalence of the RapidSense™ Drugs of Abuse Cocaine (300) device to the ACON COC One Step Cocaine Test Device.
Key Metrics
Positive Agreement: 91.1%
Negative Agreement: 95.2%
Total Agreement: 93.1%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
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.
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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:
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.
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:
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 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