(273 days)
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No
The device description and performance studies indicate a standard lateral flow immunoassay, with no mention of AI or ML technology.
No
This device is a diagnostic screening test for drugs of abuse; it does not provide therapy or treatment.
Yes
The device is intended for the detection of drug analytes in urine, providing a preliminary qualitative test result for drugs of abuse. This function aligns with the definition of a diagnostic device, as it aims to identify the presence of substances that can indicate a particular condition or state.
No
The device is described as a "lateral flow immunoassay," which is a physical test strip, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "detection of drug analytes in urine." This involves testing a sample taken from the human body (urine) outside of the body (in vitro).
- Device Description: The description as a "lateral flow immunoassay for the detection of drugs of abuse" further confirms that it's a test performed on a biological sample.
- Performance Studies: The performance studies involve testing "control urines" and comparing results to other tests and GC/MS, which are all methods for analyzing biological samples.
- Intended User / Care Setting: While it's for "professional use only," this is common for many IVDs used in clinical or laboratory settings.
The core function of the device is to analyze a biological sample (urine) to provide information about a person's health status (presence of drugs of abuse), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
First Sign™ Drugs of Abuse Screening Test are one-step lateral flow immunoassays intended for the detection of drug analytes in urine. First Sign™ Drug of Abuse Screening Test are intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels:
| Compound | Abbreviation | Level |
|---|---|---|
| Amphetamine (d-amphetamine sulfate) | AMP | 1000 ng/ml |
| Methamphetamine ((+)methamphetamine HC1) | METH | 1000 ng/ml |
| Opiates 2000 (morphine-3-P-D glucuronide) | OPI | 2000 ng/ml |
| Opiates 300 (morphine-3-P-D glucuronide) | OPI | 300 ng/ml |
| Cocaine (Benzoylecgonine) | COC | 300 ng/ml |
| Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) | THC | 50 ng/ml |
| Phencyclidine (phencyclidine HC1) | PCP | 25 ng/ml |
First Sign™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.
Product codes
DKZ, DJC, DJG, DIO, DKE, LCM
Device Description
A lateral flow immunoassay for the detection of drugs of abuse.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
For professional use only.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Product performance was compared Acon Rapid Assays manufactured by Acon Laboratories rapid tests manufactured by Acon Rapid Assays. 60 Positive and 60 negative samples were tested against each drug. All results were confirmed by GC/MS.
The First Sign™ Drugs of Abuse Screening Test was compared to a FDA substantially equivalent approved device. First Sign™ demonstrated performance of >97% for all drugs when performance was compared to a legally marketed device and GC/MS.
Reproducibility was evaluated using control urines containing drug concentrations above and below the stated cut-off. Negative controls were also tested. The results confirmed the reproducibility of the First Sign™ Drugs of Abuse Screening Test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
First Sign™ demonstrated performance of >97% for all drugs when performance was compared to a legally marketed device and GC/MS.
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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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MAY 1 9 2004
Page 33 of 38
510 (K) SUMMARY
Date of Summary: 8-18-03
Product Name:
First Sign Drug of Abuse Assays Sponsor: WHPM 9440 Telstar Ave. Unit I : 上 El Monte, CA 91731
Correspondent:
Fran White MDC Associates 163 Cabot Street Beverly, MA 01915 Substantially Equivalent Devices:
Product: Acon Rapid Drug Screens Manufactured by: Acon Laboratories
PRODUCT DESCRIPTION:
A lateral flow immunoassay for the detection of drugs of abuse.
INTENDED USE:
First Sign™ Drugs of Abuse Screening Test are one-step lateral flow immunoassays intended for the detection of drug analytes in urine. First Sign™ Drug of Abuse Screening Test are intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels:
| Compound | Abbreviation | Level |
|---|---|---|
| Amphetamine (d-amphetamine sulfate) | AMP | 1000 ng/ml |
| Methamphetamine ((+)methamphetamine HC1) | METH | 1000 ng/ml |
| Opiates 2000 (morphine-3-P-D glucuronide) | OPI | 2000 ng/ml |
| Opiates 300 (morphine-3-P-D glucuronide) | OPI | 300 ng/ml |
| Cocaine (Benzoylecgonine) | COC | 300 ng/ml |
| Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) | THC | 50 ng/ml |
| Phencyclidine (phencyclidine HC1) | PCP | 25 ng/ml |
First Sign™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the
1
510k Submission WHPM, Inc.
preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.
PERFORMANCE CHARACTERISTICS:
First Sign™ drugs of abuse screening test detects drugs in human urine at the levels indicated.
First Sign™ is substantial equivalent to Acon Rapid One Step Immunoassay Tests manufactured Acon Laboratories.
Product performance was compared Acon Rapid Assays manufactured by Acon Laboratories rapid tests manufactured by Acon Rapid Assays. 60 Positive and 60 negative samples were tested against each drug. All results were confirmed by GC/MS.
The First Sign™ Drugs of Abuse Screening Test was compared to a FDA substantially equivalent approved device. First Sign™ demonstrated performance of >97% for all drugs when performance was compared to a legally marketed device and GC/MS.
Reproducibility was evaluated using control urines containing drug concentrations above and below the stated cut-off. Negative controls were also tested. The results confirmed the reproducibility of the First Sign™ Drugs of Abuse Screening Test.
CONCLUSION:
First Sign™ Drug of Abuse Screening Test is substantially equivalent to Acon Laboratories drug of Abuse Screening Test.
:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
MAY 1 9 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
W.H.P.M., Inc. Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915
Re: K032575
Trade/Device Name: First Sign Drug of Abuse Screening Test Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DJC, DJG, DIO, DKE, LCM Dated: February 23, 2004 Received: February 24, 2004
Dear Ms. White:
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).
3
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, 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.
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
510(k) Number: K03 2515 Device Name: First Sign Drug of Abuse Screening Test
Indication for Use:
First Sign™ Drugs of Abuse Screening Test are one-step lateral flow immunoassays intended for the detection of drug analytes in urine. First Sign™ Drug of Abuse Screening Test are intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels:
| Compound | Abbreviation | Level |
|---|---|---|
| Amphetamine (d-amphetamine sulfate) | AMP | 1000 ng/ml |
| Methamphetamine ((+)methamphetamine HC1) | METH | 1000 ng/ml |
| Opiates 2000 (morphine-3-P-D glucuronide) | OPI | 2000 ng/ml |
| Opiates 300 (morphine-3-P-D glucuronide) | OPI | 300 ng/ml |
| Cocaine (Benzoylecgonine) | COC | 300 ng/ml |
| Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) | THC | 50 ng/ml |
| Phencyclidine (phencyclidine HC1) | PCP | 25 ng/ml |
First Sign™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.
. . . ...
.. . . . . . .
For professional use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over The Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | |
| (Division Sign-Off) | ||
| Division of Clinical Laboratory Devices | ||
| 510(k) Number | K032575 |