(301 days)
Not Found
No
The device description and performance studies indicate a traditional immunoassay method, and there is no mention of AI or ML terms or concepts.
No.
The device is for the qualitative detection of drugs-of-abuse in human urine, providing only a preliminary test result, and does not treat or prevent any condition.
Yes
Explanation: The device is a rapid, chromatographic immunoassay for the qualitative detection of drugs-of-abuse in human urine, which is a diagnostic function. The "Intended Use / Indications for Use" section explicitly states its purpose for detecting substances to diagnose drug abuse.
No
The device description clearly states it is a "rapid, chromatographic immunoassay," which is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative detection of drugs-of-abuse in human urine." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide information about a person's health status (presence of drugs).
- Device Description: The description reinforces the intended use by stating it's a "rapid, chromatographic immunoassay for the qualitative detection of drugs-of-abuse in human urine." Immunoassays are a common type of IVD technology.
- Anatomical Site: The anatomical site is "human urine," which is a biological specimen analyzed in vitro.
- Performance Studies: The performance studies compare the device's results to "GC/MS or HPLC results," which are standard confirmatory methods for drug testing performed in a laboratory setting (in vitro).
- Predicate Devices: The listed predicate devices are all described as "One Step" tests for detecting specific substances in urine, which are also IVDs.
The fact that it's for "Professional Use Only" and provides a "preliminary test result" that requires confirmation does not negate its classification as an IVD. It is still a test performed on a biological sample outside the body to aid in diagnosis or monitoring.
N/A
Intended Use / Indications for Use
The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine. The tests may be run singly or in combinations of up to six drugs simultaneously. The cut-off concentrations for these drugs are as follows: Nortriptyline 1,000ng/mL, Secobarbital 300ng/mL, MDMA 500ng/mL, Oxazepam 300ng/mL, Methadone 300ng/mL, Oxycodone 100ng/mL. For Professional Use Only.
Product codes (comma separated list FDA assigned to the subject device)
DJR, LFG, DIS, LAF, JXM, DJG
Device Description
The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
A clinical evaluation compared test results between the First Sign Drugs of Abuse Tests and GC/MS or HPLC results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical evaluation compared test results between the First Sign Drugs of Abuse Tests and GC/MS or HPLC results.
Nortriptyline: Positive Agreement 97.5%, Negative Agreement >99%, Overall Agreement 98.7%
Secobarbital: Positive Agreement 97.4%, Negative Agreement 97.6%, Overall Agreement 97.5%
MDMA: Positive Agreement 92.5%, Negative Agreement >99%, Overall Agreement 96.2%
Oxazepam: Positive Agreement 95.7%, Negative Agreement >99%, Overall Agreement 97.5%
Methadone: Positive Agreement 93.7%, Negative Agreement 97.9%, Overall Agreement 96.2%
Oxycodone: Positive Agreement 95%, Negative Agreement >99%, Overall Agreement 97.5%
Clinical studies demonstrate the substantial equivalence between the First Sign Drugs of Abuse Tests [Nortriptyline, Secobarbital, MDMA, Oxazepam, Methadone, and Oxycodone] and commercially available FDA-cleared drugs of abuse tests. The studies also demonstrated that the First Sign tests are safe and effective in detecting drugs of abuse at or above their stated cut-off concentrations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Nortriptyline: Positive Agreement 97.5%, Negative Agreement >99%
Secobarbital: Positive Agreement 97.4%, Negative Agreement 97.6%
MDMA: Positive Agreement 92.5%, Negative Agreement >99%
Oxazepam: Positive Agreement 95.7%, Negative Agreement >99%
Methadone: Positive Agreement 93.7%, Negative Agreement 97.9%
Oxycodone: Positive Agreement 95%, Negative Agreement >99%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K012300, K043507, K050593, K012595, K021526, K022589
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).
0
K052/97
JUN - 9 2006
510(k) Summary
Date of Summary: 30 May, 2005
Product Name
First Sign™ Drug of Abuse Urine Screening Tests
Sponsor and Manufacturer
WHPM, Inc. 9662 Telstar Avenue El Monte, CA 91731
WHPM, Bioresearch and Technology Co. Ltd. 806 Taihong Mansion, No 44 Chongwai Street Chongwai District Beijing, China 100062
Product will be manufactured in both locations and distributed through the California site.
Correspondent
Fran White, President MDC Associates, LLC 163 Cabot Street Beverly, MA 01915
Substantial Equivalency
The First Sign™ Drug of Abuse Urine Screening Test is substantially equivalent to other tests currently on the market.
| First Sign Test Analyte | Predicate Device Name | Predicate Device 510(k) # |
|---|---|---|
| Oxazepam | ACON BZO One Step Benzodiazepine Test Strip | K012300 |
| Oxycodone | ACON OXY One Step Oxycodone Test Strip | K043507 |
| Secobarbital | ACON BAR One Step Barbiturates Test Strip | K050593 |
| Methadone | ACON MTD One Step Methadone test Strip | K012595 |
| Nortriptyline | ACON TCA One Step Tricyclic Antidepressants | K021526 |
| MDMA | ACON MDMA One Step Ecstasy Test Strip | K022589 |
Product Description
The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine.
Indications for Use
The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine. The tests may be run singly or in combinations of up to six drugs simultaneously. The cut-off concentrations for these drugs are as follows: Nortriptyline 1,000ng/mL, Secobarbital 300ng/mL, MDMA 500ng/mL, Oxazepam 300ng/mL, Methadone 300ng/mL, Oxycodone 100ng/mL. For Professional Use Only.
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Performance Characteristics
A clinical evaluation compared test results between the First Sign Drugs of Abuse Tests and GC/MS or HPLC results. The results are summarized below.
| First Sign Test | Positive Agreement | Negative Agreement | Overall Agreement |
|---|---|---|---|
| Nortriptyline | 97.5% | >99% | 98.7% |
| Secobarbital | 97.4% | 97.6% | 97.5% |
| MDMA | 92.5% | >99% | 96.2% |
| Oxazepam | 95.7% | >99% | 97.5% |
| Methadone | 93.7% | 97.9% | 96.2% |
| Oxycodone | 95% | >99% | 97.5% |
Conclusion
Clinical studies demonstrate the substantial equivalence between the First Sign Drugs of Abuse Tests [Nortriptyline, Secobarbital, MDMA, Oxazepam, Methadone, and Oxycodone] and commercially available FDA-cleared drugs of abuse tests. The studies also demonstrated that the First Sign tests are safe and effective in detecting drugs of abuse at or above their stated cut-off concentrations.
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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 stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 9 2006
WHPM, Inc c/o Ms. Fran White President MDC Associates, LLC. 163 Cabot Street Beverly, MA 01915
Re: K052197
Trade/Device Name: First Sign Drug of Abuse Urine Screening Test Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR, LFG, DIS, LAF, JXM, DJG Dated: May 11, 2006 Received: May 12, 2006
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).
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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/industry/support/index.html.
Sincerely yours,
Alberto Gutierrez, Ph.D.
Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K052197
Device Name: First Sign Drug of Abuse Urine Screening Test
Indications For Use:
The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine. The tests may be run singly of in combinations of up to six drugs simultaneously. The cut-off concentrations and specific analytes tested for are listed below.
This assay provides only a preliminary test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment must be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
For Professional Use Only.
| Test Name | Analyte Tested | Cut-off Concentration |
|---|---|---|
| First Sign Nortriptyline | nortriptyline | 1,000ng/mL |
| First Sign Secobarbital | secobarbital | 300ng/mL |
| First Sign MDMA | mdma | 500ng/mL |
| First Sign Oxazepam | oxazepam | 300ng/mL |
| First Sign Oxycodone | oxycodone | 100ng/mL |
| First Sign Methadone | methadone | 300ng/mL |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CORH. Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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