(105 days)
"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.
"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).
I am sorry, but the provided text does not contain the detailed study information needed to answer your request regarding acceptance criteria and device performance. The document is an FDA 510(k) clearance letter for a device called "Rapid Drug Screen 8-Panel Low Volume II." It describes the device's indications for use and lists the cutoff concentrations for detectable substances but does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or the number/qualifications of experts.
- Information on adjudication methods, MRMC studies, or standalone performance.
- Details about the type of ground truth used or how ground truth was established for training sets.
Essentially, this document is a regulatory approval notice, not a scientific study report.
{0}------------------------------------------------
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.
{1}------------------------------------------------
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
{2}------------------------------------------------
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) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
§ 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).