(20 days)
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Not Found
No
The provided text describes a standard immunoassay for drug screening and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is an immunoassay for the qualitative detection of drugs in urine to assist in the screening of drug samples, not for treatment.
Yes
The device performs an immunoassay for the qualitative detection of various substances in human urine "to assist in the screening of drug of abuse samples," which indicates its role in identifying potential medical conditions or for monitoring states of health, a core function of a diagnostic device.
No
The provided text describes an immunoassay for detecting substances in human urine. This is a laboratory test that involves physical reagents and processes, not solely software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "Immunoassay for the qualitative detection of [various substances] in human urine to assist in the screening of drug samples." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide diagnostic information (screening for the presence of drugs).
- Anatomical Site: The specified anatomical site is "human urine," which is a biological sample.
- Professional Use: The intended user is "Professional Use," which is typical for IVD devices used in clinical or laboratory settings.
The core function of the device is to analyze a biological sample (urine) outside the body to detect specific substances, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and amphetamine in human urine to assist in the screening of druse samples. The detection cut-off concentrations are as follows:
| MET | d-Methamphetamine | 1000 ng/mL |
|---|---|---|
| OPI | Morphine | 2000 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| THC | 11-nor-Δ9-9-carboxylic acid | 50 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
| Benzodiazepine | Oxazepam | 300 ng/mL |
| Barbiturate | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| TCA | Nortriptyline | 1000 ng/mL |
| Amphetamine | d-Amphetamine | 1000 ng/mL |
Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples.
Immunoassay for the qualitative detection of THC, opiates, cocaine, methamphetamine (or amphetamine), phencyclidine and/or their metabolites in human urine to assist in screening of drug of abuse samples.
Immunoassay for the qualitative detection of THC, opiates, cocaine, methamphetamine (or amphetamine), and/or their metabolites in human urine to assist in screening of drug of abuse samples.
Immunoassay for the qualitative detection of THC, opiates, cocaine, and/or their metabolites in human urine to assist in screening of drug of abuse samples.
Immunoassay for the qualitative detection of amphetamine or methamphetamine, opiates, of abuse Immunoassay for the qualitative detection of anyman urine to assist in screening of drugs of abuse metabolites, THC metabolites, and phencyclidine in human urine to assist in niciabonici), 1999-19-19 samples. The detecting cut-off concentrations are as follows:
| THC | 11-nor-Δ9-9-carboxylic acid | 50 ng/mL |
|---|---|---|
| OPI | Morphine | 2000 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| AMP | Amphetamine | 1000 ng/mL |
| MET | D-Methamphetamine | 1000 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
Product codes (comma separated list FDA assigned to the subject device)
DJG
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
human urine
Indicated Patient Age Range
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Intended User / Care Setting
Professional Use
Prescription Use
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)
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.
Not Found
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
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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
AUG 10 1999
Mr. Jemo Kang, Ph.D. Director Princeton BioMeditech Corp. 4242 U.S. RT. 1 Monmouth Junction, New Jersey 08852
Re: K992422
Trade Name: AccuSign® DOA3 AccuSign® DOA4 AccuSign® DOA5 AccuSign® DOA8 AccuSign®DOA10 Regulatory Class: II Product Code: DJG Dated: July 20, 1999 Received: July 21, 1999
Dear Dr. Kang:
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 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). 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. A 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 regulation (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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Image /page/0/Picture/9 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted as a series of curved lines that form a shape resembling a bird or a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
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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/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
2
J(k) Number (if known): ______________________________________________________________________________________________________________________________________________________
Device Name: _ AccuSign® DQA 10 (MET/OPI//COC/THC/PCP/BZQ/BAR/MTD/TCA/AMP) Indications For Use:
Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and amphetamine in human urine to assist in the screening of druse samples. The detection cut-off concentrations are as follows:
| MET | d-Methamphetamine | 1000 ng/mL |
|---|---|---|
| OPI | Morphine | 2000 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| THC | 11-nor-Δ9-9-carboxylic acid | 50 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
| Benzodiazepine | Oxazepam | 300 ng/mL |
| Barbiturate | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| TCA | Nortriptyline | 1000 ng/mL |
| Amphetamine | d-Amphetamine | 1000 ng/mL |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Professional Use:X__________________________________________________________________________________________________________________________________________________________ Prescription Use:_X (Per 21 CFR 801.109)
OR
Over The Counter Use:
3
| Page | 1 |
|---|---|
| ------ | --- |
,10(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Professional Use:X__________________________________________________________________________________________________________________________________________________________ Prescription Use: X 'er 21 CFR 801.109)
OR
Over The Counter Use: _ _ _________
4
-10(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Levice Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Immunoassay for the qualitative detection of THC, opiates, cocaine, methamphetamine (or amphetamine), phencyclidine and/or their metabolites in human urine to assist in screening of drug of abuse samples.
. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Professional Use:X_ Prescription Use:_ X ___ (Per 21 CFR 801.109)
OR
Over The Counter Use: ______________
5
| Page | 1 of 1 |
|---|---|
| ------ | -------- |
'0(k) Number (if known): _ K 9 92422
Device Name:___ AccuSign® DOA 4 (THC/OPI200)COC/MET or AMP)
Indications For Use:
Immunoassay for the qualitative detection of THC, opiates, cocaine, methamphetamine (or amphetamine), and/or their metabolites in human urine to assist in screening of drug of abuse samples.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Professional Use:X__ Prescription Use:_X (Per 21 CFR 801.109)
OR
Over The Counter Use: ________________________________________________________________________________________________________________________________________________________
6
J(k) Number (if known): ______________________________________________________________________________________________________________________________________________________ Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Immunoassay for the qualitative detection of THC, opiates, cocaine, and/or their metabolites in human urine to assist in screening of drug of abuse samples.
Sean Cooper
(Division Sign-Off) Division of Clinical Laboratory Devices K 510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Professional Use:X__________________________________________________________________________________________________________________________________________________________ Prescription Use:_X (Per 21 CFR 801.109)
OR
Over The Counter Use: ________________________________________________________________________________________________________________________________________________________
7
9(k) Number (if known): ______________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Immunoassay for the qualitative detection of amphetamine or methamphetamine, opiates, of abuse Immunoassay for the qualitative detection of anyman urine to assist in screening of drugs of abuse
metabolites, THC metabolites, and phencyclidine in human urine to assist in niciabonici), 1999-19-19
samples. The detecting cut-off concentrations are as follows:
| THC | 11-nor-Δ9-9-carboxylic acid | 50 ng/mL |
|---|---|---|
| OPI | Morphine | 2000 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| AMP | Amphetamine | 1000 ng/mL |
| MET | D-Methamphetamine | 1000 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Professional Use:X___ Prescription Use:_X (Per 21 CFR 801.109)
OR
Over The Counter Use: ________________________________________________________________________________________________________________________________________________________