(73 days)
Not Found
Not Found
No
The provided text describes a standard immunoassay for drug detection, listing target substances and cut-off concentrations. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The "Not Found" entries for sections like "Mentions AI, DNN, or ML", "Description of the training set", and "Summary of Performance Studies" further indicate the absence of AI/ML components.
No
This device is for the qualitative detection of various substances to assist in screening drug of abuse samples, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as an "Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and medionein, phonoyoneans, on assist in screening of drug of abuse samples." This indicates its use in detecting substances in a sample, which is a diagnostic function.
No
The device is an immunoassay, which is a laboratory test that uses antibodies to detect and measure specific substances. This inherently involves physical reagents and a testing process, not just software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Immunoassay for the qualitative detection of methamphetamine, opiates. cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and medionein, phonoyoneans, on assist in screening of drug of abuse samples." This describes a test performed in vitro (outside the body) on biological samples (likely urine or other bodily fluids for drug screening) to provide diagnostic information.
- Method: The term "Immunoassay" indicates a laboratory technique used to detect and measure substances in a sample, which is a common method for IVD tests.
- Purpose: The purpose is to "assist in screening of drug of abuse samples," which is a diagnostic application.
The other sections being "Not Found" don't negate the clear indication from the "Intended Use / Indications for Use" section that this is an IVD.
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 medionein, phonoyoneans, on assist in screening of drug of abuse samples. The detecting cut-off concentrations are as follows:
| MET | D-Methamphetamine | 1000 ng/mL |
|---|---|---|
| OPI | Morphine | 300 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| THC | 11-nor-Δ 9-9-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 |
Product codes (comma separated list FDA assigned to the subject device)
LAG,DJG,DIO,DKE,LCM,DIS,DKN,DJR,LFI,DKZ
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: X
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.
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
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
DEC 1 8 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jemo Kang, Ph.D., M.B.A. Director Princeton BioMeditech Corporation P.O. Box 7139 Princeton, NJ 08543-7139
Re: K983201
Trade Name: AccuSign® DOA 10, AccuSign DOA Panel, AccuSign MET/OPI/ COC/THC/PCP/BZO/BAR/MTD/TCA/AMP Regulatory Class: II Product Code: LAG,DJG,DIO,DKE,LCM,DIS,DKN,DJR,LFI and DKZ Dated: October 5, 1998 Received: October 6, 1998
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. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act). or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice. and 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.
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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
K9835 510(k) Number (if known): __
ice Name:__AccuSign®DOA 10 (MET/QPI/COC/THC/PCP/BZO/BARMTD/TCA/AMP)
Indications For Use:
Immunoassay for the qualitative detection of methamphetamine, opiates. cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and medionein, phonoyoneans, on assist in screening of drug of abuse samples. The detecting cut-off concentrations are as follows:
| MET | D-Methamphetamine | 1000 ng/mL |
|---|---|---|
| OPI | Morphine | 300 ng/mL |
| COC | Benzoylecgonine | 300 ng/mL |
| THC | 11-nor-Δ 9-9-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 |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANN)THER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
| (Division Sign-Off) Division of Clinical Laboratory Devices | |
|---|---|
| 510(k) Number | ____________________ |
| Professional Use: | X |
| Prescription Use: | X |
| (Per 21 CFR 801.109) |
OR
| Over The Counter Use: | ____________________ |
|---|---|
| ----------------------- | ---------------------- |
(Optional Format 1-2-96)