(105 days)
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No
The device description and intended use describe a standard lateral flow immunoassay, which is a chemical-based test and does not involve AI or ML. There are no mentions of AI, ML, image processing, or data analysis methods that would suggest the use of these technologies.
No
This device is a diagnostic test used to detect the presence of certain drugs in urine; it does not provide any treatment or therapy.
Yes
The device is described as a "Rapid Drug Screen" test used for the "simultaneous detection of eight abused substances in urine." It is intended for use in "professional laboratories and physicians offices in a clinical setting" to provide a "preliminary analytical test result" for determining the need for confirmatory testing. These characteristics align with the definition of a diagnostic device.
No
The device description clearly states it is 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 "simultaneous detection of eight abused substances in urine." Urine is a biological specimen taken from the human body.
- In Vitro: The test is performed in vitro (outside of the living body) on a sample of urine.
- Diagnostic Purpose: While it provides a "preliminary analytical test result," the purpose is to detect the presence of substances that can indicate drug abuse, which is a condition related to health. The results are intended to inform further diagnostic steps (confirmatory testing).
- Clinical Setting: The intended users are "professional laboratories and physicians offices in a clinical setting," which is a typical environment for IVD use.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Detecting the presence of abused substances in urine falls under this definition as it relates to a state of health and can inform treatment or intervention.
N/A
Intended Use / Indications for Use
"Rapid Drug Screen" 8-Panel low volume test is a one-step, lateral flow immunoassay for the simultaneous detection of eight abused substances in urine (each assay occupies a separate channel). "Rapid Drug Screen" 8-Panel low volume test is intended for use in the qualitative detection of the following 8 drugs of abuse in human urine at the following levels:
| d-Amphetamine | 750 ng/ml |
|---|---|
| Barbiturates | 300 ng/ml |
| Benzodiazepines | 300 ng/ml |
| Benzoyl ecognine | 225 ng/ml |
| Cannabinoids (11-nor-9-carboxy-delta-9-THC) | 50 ng/ml |
| Methamphetamine | 1000 ng/ml |
| Opiates (codeine) | 225 ng/ml |
| (morphine-3-glucuronide) | 225 ng/ml |
| Phencyclidine (PCP) | 19 ng/ml |
"Rapid Drug Screen" 8-Panel low volume test is intended for use by professional laboratories and physicians offices in a clinical setting. The assays are easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary analytical test result for use in determining the need for additional or confirmatory testing (i.e., · gas chromatography/mass spectrometry (GC/MS)).
"Rapid Drug Screen" 8-Panel low volume test provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIO, DJG, DIS, LDJ, LCL, JXM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
professional laboratories and physicians offices in a clinical setting.
Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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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Image /page/0/Picture/1 description: The image shows the seal of 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 a stylized design featuring three human profiles, which are connected and appear to be facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 27 1998
John B. Dubeck, Esq. American Bio Medica Corporation C/O Keller and Heckman LLP 1001 G Street, NW, Suite 500W Washington, D.C. 20001
Re : K981705 Rapid Drug Screen 8-Panel Low Volume II Regulatory Class: Product Code: DKZ, DIO, DJG, DIS, LDJ, LCL, JXM Dated: August 19, 1998 Received: August 19, 1998
Dear Mr. Dubeck:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Sitman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
1 of 1
510(k) NUMBER (IF KNOWN) :
"Rapid Drug Screen" 8 Panel low volume test DEVICE NAME:
INDICATIONS FOR USE:
"Rapid Drug Screen" 8-Panel low volume test is a one-step, lateral flow immunoassay for the simultaneous detection of eight abused substances in urine (each assay occupies a separate channel). "Rapid Drug Screen" 8-Panel low volume test is intended for use in the qualitative detection of the following 8 drugs of abuse in human urine at the following levels:
| d-Amphetamine | 750 ng/ml |
|---|---|
| Barbiturates | 300 ng/ml |
| Benzodiazepines | 300 ng/ml |
| Benzoyl ecognine | 225 ng/ml |
| Cannabinoids | |
| (11-nor-9-carboxy-delta-9-THC) | 50 ng/ml |
| Methamphetamine | 1000 ng/ml |
| Opiates (codeine) | 225 ng/ml |
| (morphine-3-glucuronide) | 225 ng/ml |
| Phencyclidine (PCP) | 19 ng/ml |
"Rapid Drug Screen" 8-Panel low volume test is intended for use by professional laboratories and physicians offices in a clinical setting. The assays are easy to perform, but should not be used without proper supervision. This immunoassay is a simplified qualitative screening method that provides only a preliminary analytical test result for use in determining the need for additional or confirmatory testing (i.e., · gas chromatography/mass spectrometry (GC/MS)).
"Rapid Drug Screen" 8-Panel low volume test provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| AH An AWM | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K981705 |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter-Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|