(324 days)
Not Found
No
The device description and performance studies indicate a standard lateral flow immunoassay based on competitive binding, with no mention of AI or ML technologies.
No.
The device is an in vitro diagnostic immunoassay for qualitative detection of phencyclidine, not a therapeutic device.
Yes
The device is explicitly stated as being "For in vitro diagnostic use" in the "Intended Use / Indications for Use" section.
No
The device description clearly outlines a physical lateral flow immunoassay device that utilizes colored-latex particles and monoclonal antibodies to detect Phencyclidine in urine. This involves physical components and chemical reactions, not solely software.
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."
- Intended Use: The device is intended for the "qualitative detection for Phencyclidine in human urine," which is a biological specimen. This is a key characteristic of an in vitro diagnostic test.
- Purpose: The purpose is to provide a preliminary result for the presence of a substance in a biological sample, which is the core function of an IVD.
- Care Setting and User: It is intended for use in "professional laboratories by healthcare professionals," which aligns with the typical use of IVDs.
N/A
Intended Use / Indications 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.
Product codes
LCM
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.
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 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.
Summary of Performance Studies
Accuracy study: 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.
Key Results:
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.
Key Metrics
Positive Agreement: 96.6% (88.3 to 99.1%)
Negative Agreement: 95.6% (85.2 to 98.8%)
Total Agreement: 96.1% (90.4 to 98.5%*)
- 95% Confidence intervals
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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:
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.
1
Product 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.
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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