REDI-TEST METHAMPHETAMINE by REDWOOD BIOTECH, INC.

The Redi-Test Methamphetamine is a qualitative, one step immunochromatographic competitive assay used to screen human urine for the presence of d, methamphetamine at a cutoff concentration of 1000ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.

Device Description

The Redi-Test Methamphelamine is an immunochromatographic based one step in vitro lest.

AI/ML Overview

The provided text describes a 510(k) summary for the "Redi-Test Methamphetamine" device, comparing it to a predicate device, the "DRI Amphetamine Enzyme Immunoassay." The study is a comparative one to demonstrate substantial equivalence, rather than a standalone performance study against a predefined acceptance criterion.

Here's the information broken down:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the desired level of agreement. The study does not explicitly state pre-defined acceptance criteria in terms of sensitivity or specificity independently. Instead, it aims for substantial equivalence, which is demonstrated by a high agreement percentage with the predicate device.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (Redi-Test Methamphetamine vs. DRI Amphetamine EIA)
Overall Agreement	High agreement with predicate device (DRI Amphetamine Enzyme Immunoassay)	94%
Discrepancy Analysis	Discrepancies to be understood and justifiable	5 samples positive by DRI EIA, negative by Redi-Test, GC/MS between 300-800ng/mL. 1 sample negative by DRI EIA, positive by Redi-Test, GC/MS at 1100ng/mL.
Cut-off Sensitivity	Equivalent to predicate device	1000ng/mL (same as DRI EIA)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 102 specimens
- 45 negative for methamphetamine
- 57 positive for methamphetamine
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study involves "specimens" which typically refers to real-world samples, but the collection method (retrospective or prospective) is not defined.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for the discrepancies appears to have been established using an alternate methodology, GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold standard for confirming drug presence and concentration. This does not involve human experts in the sense of adjudication for interpretation, but rather a definitive analytical test.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication" for discrepant samples was performed by an objective analytical method (GC/MS), rather than human expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This study is for an in-vitro diagnostic (IVD) device (a chemical test kit) and does not involve human readers or AI in its diagnostic process.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in a way, the study evaluates the "standalone" performance of the Redi-Test Methamphetamine device by comparing its results directly to another IVD device (DRI Amphetamine Enzyme Immunoassay) and then using GC/MS for validation of discrepant results. It's a "device-only" performance assessment.

7. The Type of Ground Truth Used

For demonstrating substantial equivalence: The predicate device, the "DRI Amphetamine Enzyme Immunoassay," served as a primary reference for comparison.
For resolving discrepancies/validation: GC/MS (Gas Chromatography/Mass Spectrometry) was used as the definitive analytical method to determine the actual methamphetamine levels in discrepant samples.

8. The Sample Size for the Training Set

Not applicable. This is an immunochromatographic test kit, which is a chemical assay, not a machine learning or AI-based device that requires a training set. The device itself is "trained" during its manufacturing and quality control processes.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The performance characteristics are inherent to the chemistry and design of the immunochromatographic assay.

Summary

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JUL 22 1999

K991504

510(k) Summary

I his 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: 991504 1. Date of summary. July 1, 1999

Redwood Biotech 3573 2. Submitted by: Westwind Blvd. Santa Rosa, CA 95403 TEL 707-577-7959 FAX 707-577-0365 Contact: Robert Mount

Redi-Test Methamphetamine 3. Device Name:

Device Classification: Class 11, 862.3610, Panel 91 Toxicology
Device description: The Redi-Test Methamphelamine is an immunochromatographic based one step in vitro lest.
Intended Use: The Redi-Test Methamphetamine Is a qualitative, one step immunochromatographic competitive assay used to screen human urine for the presence of d. melliamphetamine at a cutoff ooncontration of 1000ng/ml The test is qualitative and provides only a proliminary analytical result, which must be confirmed by an alternate methodology preferanty. GC/MS.
Substantial Equivalence: The Redi Test Methamphetamine was found substantially equivalent to the DRI. Amphetamine Enzyme Immunoassay. Both products are immunoassays and use spectic antibodies. The DRI Amphetamine assay detects amphetamine and methamine while the Rodi-Test Mothamphetamine detects methamphetamine. Both assays are proliminary screens and require confirmation will alternate methods such as GC/MS. The cut off sensitivity of both tests is 1000ng/ml. The tests demonstrated 94% agreement when 102 specimens (45 negative and 57 positive) were compared. Five of the six discrepant samples were positive by the DRI Amphetamine EIA, negative by the Redi-Test Methamphetamine and between 300 and 800ng/mL methamphetamine by GC/MS. One sample was negative by the DRI EIA and positive by the Redl-Test this sample had a GC/MS methamphetamine level of 1100ng/mL.

Conclusion:

The DRI Amphetamine Enzyme Immungassay and the Redi-Test Mcthamphetamine are substantially equivalent in performance characteristics. The correlation between the two tests was 94%.

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JUL 2 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Redwood Biotech Inc. Ms. Janis Freestone c/o Advantage Diagnostics Corp. 2440 Leghorn Street Mountain View, California 94043

Re: K991504

Trade Name: Redi-Test Methamphetamine Regulatory Class: II Product Code: LAF Dated: June 21, 1999 Received: June 30, 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 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.

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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 Toutman

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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510k Number:

Device Name: Redi-Test Methamphetamine

Indications for Use:

Sean Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices 504 510(k) Number ...

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over the counter use

Regulation Number and Section

§ 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).