(33 days)
Not Found
No
The summary describes a qualitative drug screening device for urine, with no mention of AI, ML, image processing, or any computational analysis beyond a simple chemical reaction interpretation.
No
The device is a rapid drug screen for detecting substances in human urine, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as a "rapid drug screen" for the "determination of Cocaine, Triavelier, Opiates, Marijuana, PCF, Barontales, Donzoulasspance, Barry, Tricyclics, Methampletamine and Ecstasy in human urine." This indicates it is used to identify the presence of substances in a biological sample, which is a diagnostic function.
No
The 510(k) summary describes a device for drug screening in human urine, which strongly suggests a physical test kit or analyzer is involved, not just software. The lack of any mention of software or digital components further supports this conclusion.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "determination of Cocaine, Triavelier, Opiates, Marijuana, PCF, Barontales, Donzoulasspance, Barry, Tricyclics, Methampletamine and Ecstasy in human urine." This involves testing a sample taken from the human body (urine) outside of the body to gain information about a person's health or condition (presence of drugs).
- Anatomical Site: The anatomical site is listed as "human urine," which is a biological sample.
- Qualitative Results: The device provides "only qualitative results," which is a common characteristic of many IVD tests.
These factors align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
The ABM Rapid Drug Screen™ is for the determination of Cocaine, Tricyclics, Methamphetamine and Opiates, Marijuana, PCP, Barbiturates, Benzodiazepines, by visual interpretation of qualitative results and is intended for professional use only.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIO, LDJ, DJG, DIS, JXM, DJC, LCM, LFI
Device Description
Not Found
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 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 862.3100 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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 wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle's perimeter.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
American Bio Medica Corporation c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915
510(k) Number: K012159 Re: Trade/Device Name: Rapid Drug Screen™ Trade/Device Name: Rapid Drug Screen
Regulation Number: 862.3100, 862.3250, 862.3650, 862.3170, 862.3170,
Regulation Number: 862.3100, 862.3210 862.3610, 862.3910
JUL 2 5 2001
Regulatory Class: II Regulatory Class: 11
Product Code: DKZ, DIO, LDJ, DJG, DIS, JXM, DJC, LCM, LFI Dated: July 13, 2001 Received: July 17, 2001
Dear Ms. White:
We have reviewed your Section 510(k) notification of intent to market the devices merketed in We have reviewed your Section 510(x) notificantially equivalent to devices marketed in
above and we have determined the device is substantially of the Modicel Davice above and we nave determined the device is the enactment date of the Medical Device interstate commerce pror to May 20, 1978, the encordance with the provisions of the dayine, subject to Amendments, of to devices man have been receifice, market the device, subject to
Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, of the Ast include Federal Food, Drug, and Cosmone Free (110).
the general controls provisions of the Act. The general controls provisions proctine proctine argentiae, lobaling the general controls provisions of the Act. "The general vood manufacturing practice, labeling, requirembitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III) If your device is classified (sec above) and cuch additional controls. Existing major regulations
(Premarket Approval), it may be subject to such additions, Title 21, Parts (Premarket Approval), it may be subject to suen actively Regulations, Title 21, Parts 800 to 895.
affecting your device can be found in the Code of Federal Regulations, Title affecting your device can be found in the Ossumes compliance with the Cood Manufacturing A substantially equivalent actemination assummation (21 CFR Part 820) and that, through Practice Iol Medical Devices: "Sentral (Children) (FDA) will verify such periodic GMP Inspections, the I ood and Drog Namestion may result in regulatory action. In
assumptions. Failure to comply with the GMP regulation may result wise in the Fed assumptions. Fallure to comply with the GMT regulation your device in the Federal addition, FDA may publish further announcemarket notification submission does not affect
Register. Please note: this response to your premarket notification and the Register. Please note: this response to your printered 542 of the Act for devices under the any obligation you might have under becauses or other Federal laws or regulations.
1
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) prematket This letter will allow you to begin marketing your device to a legally marketed
notification. The FDA finding of substantial equivalee of your device to notification. The FDA finding of substantial equivalence of 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 If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitto diagnostic devices), please contact the Office of additionally 809.10 for in vitto dagnostic nevestions on the promotion and advice, and device, and (301) 594-4588. Additionally, for questions on une promote the regulation
please contact the Office of Compliance at (311) 594-4639. Also, please note the regulation please contact the Office of Compliance at (301) - 1037 - 1201 (FR 807.97). Other general
entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Oth entitled, "Misbranding by reference of prematics (professor the Division of Small
information on your responsibilities under the Act may be obtained from the Division of Smal information on your responsibilities under (800) 638-2041 or (301) 443-6597 or at its
Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at Manufacturers Assistance at its ton tres collections and mamain.html".
internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Office of Dovices and Radiological Health
Enclosure
2
Special 510k Rapid Drug Screen Original 510 (k) number: K002447 American BioMedica Corporation
Page 9 of 14
510(k) Number: Kora 159 Device Name: Rapid Drug Screen™
Indication for Use: The ABM Rapid Drug Screen™ is for the determination of Cocaine,
Triavelier, The ABM Rapid Drug Screen Trievelies, Mothemphetamine and Indication for Use: The ADM Rapid Driven Tricyclics, Methampletamine and Opiates, Marijuana, PCF, Barontales, Donzoulasspance, Barry, Qualitative results and is intended for professional use only.
Fred Lacy
(Division Sign-Off) (Division Sigil-On)
Division of Clinical Laboratory Deviews K012159 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
..............................................................................................................................................................................
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over The Counter Use (Optional Format 1-2-96)