REDI-TEST COCAINE

• K Number: K991110
• Device Name: REDI-TEST COCAINE
• Manufacturer: REDWOOD BIOTECH, INC.
• Date Cleared: 1999-07-26 ( 116 days)
• Product Code: DIO
• Regulation Number: 862.3250
• Type: Traditional
• Panel: Toxicology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Redi-Test Cocaine is a qualitative, one step immunochromatographic competitive assay used to screen human urine for the presence of the cocaine metabolite, benzoylecgonine at a cutoff concentration of 300ng/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 Cocaine is an immunochromatograpic based one step in vitro test.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Redi-Test Cocaine device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Correlation with predicate device (DRI Cocaine Enzyme Immunoassay)	99% correlation
Detection of benzoylecgonine at a cutoff of 300ng/mL	The Redi-Test Cocaine detects benzoylecgonine at a cutoff concentration of 300ng/mL
Performance similar to predicate device in terms of sensitivity, specificity, accuracy, and precision.	The tests (Redi-Test Cocaine and DRI Cocaine Enzyme Immunoassay) are similar in sensitivity, specificity, accuracy, and precision.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: 100 specimens (50 negative, 50 positive over the entire assay range).
   • Data Provenance: Not explicitly stated, but implies collected specimens for comparison in a single study. No country of origin is mentioned, nor is it explicitly stated as retrospective or prospective. However, given the nature of a 510(k) submission for a new device, it is likely a prospective comparison study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. The "ground truth" seems to be established by the predicate device's results and confirmed by an alternate methodology (GC/MS).

3. Adjudication method for the test set:

   • Not applicable as the "ground truth" for comparison was the DRI Cocaine Enzyme Immunoassay, and confirmation was to be done by GC/MS. There is no mention of human expert adjudication in the traditional sense.

4. 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 is an in vitro diagnostic (IVD) device for substance detection, not an AI imaging or diagnostic device that involves human readers interpreting results in a comparative effectiveness study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, this was a standalone performance evaluation. The device itself performs the detection (immunochromatographic assay). The study compared the performance of this device against a predicate device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The primary ground truth for comparison was the DRI Cocaine Enzyme Immunoassay (the predicate device). The intended use states that "preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS," indicating that GC/MS is considered the gold standard for confirmation. Therefore, the ground truth is a combination of comparison to a recognized predicate method and a gold standard confirmatory method (GC/MS).

7. The sample size for the training set:

   • Not applicable/Not specified. This is an immunoassay device, not a machine learning algorithm that requires a training set in the typical sense. The device's performance is based on its inherent chemical and immunological properties.

8. How the ground truth for the training set was established:

   • Not applicable. (See #7).

Summary

{0}------------------------------------------------

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:__K 99||||0

1. Date of summary: March 31, 1999

• Redwood Biotech 3573 Westwind Blvd. Santa Rosa, CA 95403 2. Submitted by: TEL [phone] FAX [phone] Contact: Robert Mount
• 3. Device Name: Redi-Test Cocaine

4. Device Classification: Class II, 862.3250, Panel 91 Toxicology

5. Device description: The Redi-Test Cocaine is an immunochromatograpic based one step in vitro test.

6. Intended Use: The Redi-Test Cocaine is a qualitative, one step immunochromatographic competitive assay used to screen human urine for the presence of the cocaine metabolite, benzoylecgonine at a cutoff concentration of 300ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.

7. Substantial Equivalence: The Redi-Test Cocaine was found substantially equivalent to the DRI. Cocaine Enzyme Immunoassay. Both products are immunoassays and use specific antibodies to detect the major metabolite of cocaine, benzoylecgonine. Both assays are preliminary screens for human urine and require confirmation with alternate methods such as GC/MS. The sensitivity of the tests are similar, the DRI and Redi-Test both detect benzoylecgonine at a cut off of 300ng/mL. The tests demonstrated 99% correlation when 100 specimens (50 negative and 50 positive over the entire assay range) were compared. The tests are similar in sensitivity, specificity, accuracy and precision.

Conclusion:

The Cocaine Enzyme Immunoassay and the Redi-Test Cocaine are substantially equivalent in performance characteristics. The correlation of the two tests was 99%,

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is in black and white.

JUL 26 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K991110

Trade Name: Redi-Test Cocaine Regulatory Class: II Product Code: DIO Dated: July 13, 1999 Received: July 14, 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.

{2}------------------------------------------------

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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours.

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

{3}------------------------------------------------

510k Number:

Device Name: Redi-Test Cocaine

Indications for Use:

The Redi-Test Cocaine is a qualitative, one step immunochromatographic The Redi-Test Cocaine is a qualitative, one of the presence of the cocaine
competitive assay used to screen human urine for the presence of the tocal is compellive assay used to screen haman annon of 300ng/mL. The test is
metabolite, benzoylecgonine at a cutoff concentration of 300ng/mind be metabolite, benzoylecgonine at a saton sonalytical result which must be qualitative and proternate methodology preferably GC/MS.

de kirk) Mundber a less less lessing les lesinill on noisivid
leaders de lesinill on noieivid
leaster leading and leasing (a) le (HO-mgi2 noisiviO)

Jan Coope

(Division Sign-Off)

Divis of Clinical Laboratory Devices 510(k) Number_k 991110

પરિદ SCRIPTION

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).