REDI-TEST PCP

• K Number: K991698
• Device Name: REDI-TEST PCP
• Manufacturer: REDWOOD BIOTECH, INC.
• Date Cleared: 1999-08-25 ( 99 days)
• Product Code: LCM
• Regulation Number: N/A
• Type: Traditional
• Panel: Toxicology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Redi-Test PCP is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of phencyclidine at a cut off concentration of 25ng/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 PCP is an immunochromatograpic based one step in vitro test.

AI/ML Overview

The provided text describes the Redi-Test PCP device, its intended use, and a comparison study performed for its 510(k) submission. However, it does not explicitly state "acceptance criteria" as a predefined numerical threshold for performance. Instead, the study aims to demonstrate substantial equivalence to an existing predicate device. The performance is assessed by comparing the new device's results to the predicate device's results.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied by Substantial Equivalence Claim)	Reported Device Performance
Correlation	>99% correlation with predicate device	>99% correlation
Sensitivity	Similar to predicate device (DRI Phencyclidine EIA)	Similar to predicate device
Specificity	Similar to predicate device (DRI Phencyclidine EIA)	Similar to predicate device
Accuracy	Similar to predicate device (DRI Phencyclidine EIA)	Similar to predicate device
Precision	Similar to predicate device (DRI Phencyclidine EIA)	Similar to predicate device
Cut-off	25 ng/mL (to match predicate device)	25 ng/mL

Explanation of Implied Acceptance Criteria: The document explicitly states, "The PCP Enzyme Immunoassay and the Redi-Test PCP are substantially equivalent in performance characteristics. The correlation of the two tests was >99%." This implies that the acceptance criterion for the study was to achieve a correlation of >99% and demonstrate similar performance across other key metrics (sensitivity, specificity, accuracy, precision) when compared to the predicate device. For diagnostic devices, demonstrating substantial equivalence to a legally marketed predicate device is a common regulatory pathway.

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

• Sample Size: 100 specimens (50 negative and 50 positive, covering the entire assay range).
• Data Provenance: Not explicitly stated. It is not mentioned if the data was retrospective or prospective, nor the country of origin.

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

• This information is not provided in the text. The "ground truth" for this study was the results obtained from the predicate device, the DRI Phencyclidine Enzyme Immunoassay. The study's goal was to show similarity to this established method, not to establish a new ground truth using experts.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. Since the "ground truth" was the predicate device's results, there was no expert adjudication process for the test set itself in the way it might be applied for, e.g., image interpretation based on multiple expert opinions. The comparison was directly between the Redi-Test PCP and the predicate device's readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This study is a device-to-device comparison, assessing the performance of the new device against a predicate device, not the improvement of human readers with or without AI assistance.

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

• Yes, a standalone performance study was done. The Redi-Test PCP is an in vitro diagnostic (IVD) device that provides a direct result. The comparison was of the device's output (positive/negative for phencyclidine at a specific cut-off) against the output of the predicate device. There is no "human-in-the-loop" component for interpretation described beyond the technician performing the test and reading the result.

7. The Type of Ground Truth Used

• The "ground truth" for comparison was the results obtained from the predicate device, the DRI Phencyclidine Enzyme Immunoassay. The document indicates that both assays require confirmation by an alternate methodology, preferably GC/MS, for definitive results. This suggests that while the predicate device serves as the comparative standard for this submission, the ultimate "true ground truth" for patient management would be GC/MS.

8. The Sample Size for the Training Set

• This information is not provided and is likely not relevant for this type of immunoassay device. Immunoassays typically do not have a "training set" in the machine learning sense. Their performance is inherent to their chemical and biological design. The "testing" referred to is for validation, not for training a model.

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

• This information is not applicable as there is no "training set" for an immunochromatographic device in the context of this submission.

Summary

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AUG 25

510(k) Summarv

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:________________________________________________________________________________________________________________________________________________

1. Date of summary:

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

4. Device Classification: Class II, Panel 91 Toxicology

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

6. Intended Use: The Redi-Test PCP is a qualitative, one step immunochromatographic competitive assay used to screen human urine for the presence of the phencyclidine at a cut off concentration of 25 ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an altemate methodology preferably. GC/MS.

7. Substantial Equivalence: The Redi-Test PCP was found substantially equivalent to the DRI, Phencyclidine Enzyme Immunoassay. Both products are immunoassays and use specific antibodies to detect phencyclidine. Both assays are preliminary screens for human urine and require confirmation with altemate methods such as GC/MS. The sensitivity of the tests are similar, the DRI and Redi-Test both detect phencyclidine at a cut off concentration of 25 no/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 PCP Enzyme Immunoassay and the Redi-Test PCP are substantially equivalent in performance characteristics. The correlation of the two tests was >99%.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 25 1999

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

Re: K991698

Trade Name: Redi-Test PCP Regulatory Class: II Product Code: LCM Dated: August 17, 1999 Received: August 18, 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 (OS) 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 [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 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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510k Number:

Device Name: Redi-Test PCP

Indications for Use:

The Redi-Test PCP is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of phencyclidine at a cut off concentration of 25ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.

P. Berhaut (for J. Cooper, ovm)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991698

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Regulation Number and Section

N/A