(20 days)
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.
The Redi-Screen is an immunochromatographic based one step in vitro test.
Here's a breakdown of the acceptance criteria and the study information for the Redi-Screen device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold for the device's performance compared to a gold standard. Instead, it describes comparison studies that show the device's agreement with predicate devices. The "acceptance criteria" here implicitly refers to showing substantial equivalence.
| Analyte | Stated Cut-off Level | Predicate Device Agreement (% Range) |
|---|---|---|
| THC | 50 ng/mL | >96% to >99% |
| PCP | 25 ng/mL | >96% to >99% |
| Opiates | 300 ng/mL | >96% to >99% |
| Cocaine | 300 ng/mL | >96% to >99% |
| Methamphetamine | 1,000 ng/mL | >96% to >99% |
Note: The agreement percentage is a range provided for "all aspects" of the comparison studies against commercially available EIA DOA tests, not specific to each analyte.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document only mentions "comparison studies" and "precision studies."
- Data Provenance: Not explicitly stated. Given it's a submission to the FDA for a device intended for clinical laboratories, it's likely the data was collected in a controlled laboratory setting, but the country of origin is not specified, nor whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. This device is an in-vitro diagnostic (IVD) for drug screening. Ground truth for such devices is typically established through analytical methods like GC/MS, not expert consensus on interpretations.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this isn't a device that requires human expert adjudication for establishing ground truth. The confirmation method is "alternate methodology, preferably GC/MS."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This is an in-vitro diagnostic device and does not involve human readers interpreting results in the way an imaging AI would. Therefore, an MRMC study is not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, essentially. The Redi-Screen is a standalone immunochromatographic test. Its performance is evaluated intrinsically through comparison studies, precision studies, specificity, and validation of cut-offs. It provides "only a preliminary analytical result," indicating it operates independently to provide that result, which then requires external confirmation (GC/MS).
7. The Type of Ground Truth Used:
The primary "ground truth" or reference method for comparison is:
- "Commercially available EIA DOA tests"
- For confirmation of results, "alternate methodology preferably, GC/MS" (Gas Chromatography/Mass Spectrometry), which is considered a gold standard for drug detection.
8. The Sample Size for the Training Set:
Not applicable. The Redi-Screen is an immunochromatographic assay, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its "training" is inherent in the design and optimization of its biochemical components (antibodies, reagents) during manufacturing and development.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there isn't a "training set" in the context of an AI algorithm. The performance of the biochemical reagents and device design is validated against known concentrations of analytes and cross-reacting substances, using methods like GC/MS to prepare and verify those samples.
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:
L993100
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: September 16, 1999
- Redwood Biotech Inc. 2. Submitted by: 3573 Westwind Blvd. Santa Rosa, CA 95403 TEL 707-577-7959 FAX 707-577-0365 Contact: Robert Mount
Redi-Test Screen 3. Device Name:
-
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 performance testing for both tests were similar in all aspects including; comparison studies which ranged between >96% and > 99%
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agreement when compared to commercially available EIA DOA tests, precision studies, which both demonstrated a high degree of reproducibility, specificity which indicated no cross reaction with several unrelated drug compounds, and validation of drug cut offs which were within ±25% of the cut off for both tests.
Conclusion:
The Redi-Screen is substantially equivalent in all performance characteristics to the individual Redi-Test THC, Opiates PCP, Cocaine and Methamphetamine.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads. The eagle is facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 6 1999
Redwood Biotech Inc. c/o Ms. Janis Freestone Advantage Diagnostics Corporation 2440 Leghorn Street Mountain View, California 94043
Re: K993100 Trade Name: Redi-Screen Regulatory Class: II Product Code: DJC, LDJ, DIO, DJG, Dated: September 15, 1999 Received: September 16, 1999
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 OS 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.
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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/cdrlvdsma/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
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Attachment 2
510k Number:
Device Name: Redi-Screen
Indications for Use:
The Redi-Screen is a qualitative, one step, immunochromatographic competitive assay The Redi-Screen human urine for 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.
Jean Cooger
(Division Sign-Off)
Division of Clinical Laborator Devices
510(k) Number K993100.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over the counter use _
§ 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).