← Product Code LCM · K080431 # RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 (K080431) _Quantrx Biomedical Corporation · LCM · Jan 8, 2009 · TX · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K080431 ## Device Facts - **Applicant:** Quantrx Biomedical Corporation - **Product Code:** LCM - **Decision Date:** Jan 8, 2009 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** TX ## 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. ## Device Story RapidSense™ PCP 25 is a lateral flow competitive immunoassay for qualitative detection of Phencyclidine in human urine. Device uses colored latex particles and monoclonal antibodies; competitive binding principle. In absence of drug, no signal appears at test line (T); presence of drug at or above 25 ng/mL cut-off produces blue line at test zone (T). Red control line (C) verifies sample volume and flow. Used in professional laboratories by healthcare professionals. Provides preliminary screening results; requires confirmation via GC/MS. Assists clinicians in identifying potential drug use; clinical judgment required for interpretation. ## Clinical Evidence Method comparison study using 103 clinical urine samples (45 negative, 58 positive) compared against GC/MS. Results showed 97% agreement among positives and 96% agreement among negatives. Analytical precision study conducted over 10 days with 3 operators and 3 lots confirmed performance around the 25 ng/mL cutoff. Specificity testing evaluated cross-reactivity and potential interference from common substances, pH, and specific gravity; no interference observed. ## Technological Characteristics Lateral flow immunochromatographic assay. Components: monoclonal mouse anti-PCP antibody, mouse monoclonal anti-protein A antibody, colloidal gold/latex-labeled antigen conjugates. Single-use cassette format. Visually read. No instrumentation required. Stability testing per CEN 13640. ## Predicate Devices - ACON PCP One Step Phencyclidine Test Strip and Test Device (k011730) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. {2}------------------------------------------------ ## 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. {3}------------------------------------------------ ## 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 {4}------------------------------------------------ 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, 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 {5}------------------------------------------------ # 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 Page 2 of 2 --- **Source:** [https://fda.innolitics.com/device/K080431](https://fda.innolitics.com/device/K080431) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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