(14 days)
Redi-THC, Redi-PCP, Redi-Cocaine, Redi-Opiates, Redi-Methamphetamine
Not Found
No
The device description and intended use clearly describe a standard immunochromatographic assay, which is a chemical reaction-based test and does not involve AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is described as an "immunochromatographic competitive assay for the qualitative determination of the presence of THC, Phencyclidine, Opiates, Cocaine and Methamphetamine." This is a diagnostic function, not a therapeutic one. It identifies substances, it does not treat or alleviate a medical condition.
Yes
The device is described as a qualitative assay for the determination of the presence of specific substances (THC, Phencyclidine, Opiates, Cocaine, Methamphetamine), which is a diagnostic function to identify the presence or absence of certain markers in a sample.
No
The device description clearly states it is an "immunochromatographic based one step in vitro test," which is a hardware-based assay, not 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 it's for the "qualitative determination of the presence of THC, Phencyclidine, Opiates, Cocaine and Methamphetamine" in a sample. This is a diagnostic purpose.
- Device Description: The device description clearly states it is an "immunochromatographic based one step in vitro test." The term "in vitro" is a key indicator of an IVD.
- Nature of the Test: The test analyzes a sample (presumably urine, though not explicitly stated, it's common for drug screens) outside of the body to provide information about a person's health status (presence of drugs).
The other sections, while important for regulatory review, don't contradict the classification as an IVD. The fact that it's for use in clinical laboratories by healthcare and forensic professionals further supports its role as a diagnostic tool.
N/A
Intended Use / Indications for Use
The Redi-Screen is designed for the qualitative determination of five (5) DOA and their metabolites in human urine specimens. The five DOA include THC, PCP, Opiates, Cocaine and Methamphetamine. The presence of these drugs and their cross-reacting metabolites in human urine can be detected above the following cut off levels: THC 50ng/mL, PCP 25ng/mL, Opiates 300ng/mL, Cocaine 300ng/mL, Methamphetamine 1,000ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS. This test is for use in clinical laboratories by health care and forensic professionals only.
Product codes
LAF, LDJ, LCM, DJG, DIO
Device Description
The Redi-Screen is an immunochromatographic based one step in vitro test.
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
clinical laboratories by health care and forensic professionals
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)
the Redi-THC. Redi-PCP. Redi-Cocaine. Redi-Opiates and Redi-Methamphetamine.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Kooo977
Attachment 4
510(k) Summary
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.
The assigned 510(k) number is:
-
- Date of summary: March 17, 2000
- Redwood Biotech Inc. 3573 Westwind Blvd. Santa Rosa, CA 2. Submitted by: 95403 TEL 707-577-7959 FAX 707-577-0365 Contact: Robert Mount
-
Device Name: Redi-Screen
-
Device Classification: Class II, Panel 91 Toxicology
-
Device description: The Redi-Screen is an immunochromatographic based one step in vitro test.
-
Intended Use: The Redi-Screen is designed for the qualitative determination of five (5) DOA and their metabolites in human urine specimens. The five DOA include THC, PCP, Opiates, Cocaine and Methamphetamine. The presence of these drugs and their cross-reacting metabolites in human urine can be detected above the following cut off levels:
| THC | 50ng/mL |
|---|---|
| PCP | 25ng/mL |
| Opiates | 300ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1,000ng/mL |
The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
This test is for use in clinical laboratories by health care and forensic professionals only.
- Substantial Equivalence: The Redi-Screen was found substantially equivalent to the five single tests for the individual DOA. i.e., the Redi-THC. Redi-PCP. Redi-Cocaine. Redi-Opiates and Redi-Methamphetamine. All products are immunoassays and use specific antibodies to detect various drug compounds. Both predicate and modified tests are preliminary screens for human urine and require confirmation with alternate methods such as GC/MS. The sensitivity for the Redi Screen is equivalent to the single tests.
Conclusion:
The Redi-Screen is substantially equivalent to the individual Redi-Test THC, Opiates PCP, Cocaine and Methamphetamine.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 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 wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
APR 1 0 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Redwood Biotech Inc. c/o Ms. Janis Freestone Charlton Associates 1206 Sesame Drive Sunnyvale, California 94087
K000979 Re:
Trade Name: Redi-Screen Regulatory Class: II Product Code: LAF, LDJ, LCM, DJG, DIO Dated: March 23, 2000 Received: March 27, 2000
Dear Ms. Freestone:
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.
2
Page 2
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" (21CFR 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 Sutman
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
3
Attachment 2
510k Number:
Device Name: Redi-Screen
Indications for Use:
The Redi-Screen is a qualitative, one step, immunochromatographic competitive assay rne Rour Our of a qualified of the presence of THC, Phencyclidine, Opiates, Cocaine and Methamphetamine at the following cut off concentrations;
| THC | 50ng/mL |
|---|---|
| РСР | 25ng/mL |
| Opiates | 300ng/mL |
| Cocaine | 300ng/mL |
| Methamphetamine | 1,000ng/mL |
The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
(Division Sign-Off)
Division of Clinical Labo
510(k) Number: CC 979
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over the counter use_