The Emit® II Plus Phencyclidine Assay is a homogeneous enzyme immunoassay with a 25 ng/mL cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of phencyclidine in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

The Emit® II Plus Phencyclidine Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Device Description

The Emit® II Plus Phencyclidine Assay is a homogenous enzyme assay intended for use in qualititative and semiquantitative analysis of phencyclidine in human urine. The Emit® II Plus Phencyclidine Assay and has been found to be equivalent to the predicate device: Emit® II Phencyclidine Assay with regard to intended use, assay sample, and overall performance characteristics.

AI/ML Overview

Here's an analysis of the provided text regarding the Emit® II Plus Phencyclidine Assay, focusing on acceptance criteria and the supporting study:

The provided document describes a 510(k) submission for the Emit® II Plus Phencyclidine Assay, establishing its substantial equivalence to a predicate device (Emit® II Phencyclidine Assay). The studies presented are primarily for demonstrating this equivalence.

Acceptance Criteria and Reported Device Performance

The document describes several performance characteristics rather than explicit acceptance criteria with pre-defined thresholds for each. However, we can infer the implied acceptance criteria from the reported results and the comparison to the predicate device.

Performance Characteristic	Stated Acceptance Criteria (Inferred)	Reported Device Performance (Emit® II Plus)
Qualitative Analysis	Excellent correlation to the predicate device (Emit® II Phencyclidine Assay).	99% agreement with the predicate device using a 25 ng/mL cutoff. One discordant sample (15 ng/mL PCP by GC/MS) was positive by Emit® II Plus and negative by Emit® II.
Spiked Sample Recovery (Qualitative)	Consistently distinguish negative vs. positive: < 25% of cutoff should be negative; > 25% of cutoff should be positive.	Spiked levels < 25% of 25 ng/mL cutoff (0 - 18.75 ng/mL) were consistently distinguished as negative. Spiked levels > 25% of 25 ng/mL cutoff (31.25 - 300 ng/mL) were consistently distinguished as positive.
Spiked Sample Recovery (Semiquantitative)	Quantitated results within 10% of nominal concentration for a specified range.	Quantitated within 10% of nominal concentration between 8.0 ng/mL and 90 ng/mL.
Precision (Qualitative - Within-run)	Acceptable within-run precision for controls and cutoff (rates).	%CV for controls and cutoff (rates) at 0.5%.
Precision (Qualitative - Total)	Acceptable total precision for controls and cutoff (rates).	%CVs for controls and cutoff (rates) ranged from 0.5 to 0.6%.
Precision (Semiquantitative - Within-run)	Acceptable within-run precision for controls and cutoff (concentrations).	%CV for controls and cutoff (concentrations) ranged from 1.79 to 2.44%.
Precision (Semiquantitative - Total)	Acceptable total precision for controls and cutoff (concentrations).	%CV ranged from 2.18 to 2.60%.
Correlation with GC/MS	Good relationship between semiquantitative analyses and GC/MS values. (This is a more general statement of acceptance rather than a specific numeric criterion).	Demonstrated a "good relationship" between semiquantitative analyses and GC/MS values for all positive samples and a portion of negative samples (n=20).

Study Details

This document describes a performance study conducted to demonstrate substantial equivalence, not a standalone clinical validation study in the traditional sense, especially concerning an AI/ML device.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: 100 specimens for comparative analysis (49 positive, 50 negative by both Emit® II Plus and Emit® II).
- Data Provenance: Not explicitly stated (e.g., country of origin, demographics). The study appears to be laboratory-based internal testing, likely retrospective using collected urine samples. It is implied the samples are human urine.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the context of this device. The ground truth for drug-of-abuse testing is established by confirmatory methods (like GC/MS) and reference assays (the predicate Emit® II assay), not by human expert opinion.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. When there was a discrepancy between the Emit® II Plus and the predicate Emit® II assay, Gas Chromatography/Mass Spectrometry (GC/MS) was used as the confirmatory (adjudication) method. For example, one discordant sample was confirmed by GC/MS to have 15 ng/mL of PCP.
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:
- No. This is not an AI/ML device, nor does it involve human readers interpreting images or data. It is an in vitro diagnostic (IVD) assay that provides quantitative and qualitative results directly.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in the sense that it's an automated assay. The Emit® II Plus Phencyclidine Assay is a homogeneous enzyme immunoassay designed for use with chemistry analyzers, meaning it provides results without direct human interpretation of a visual output where human error in reading is a factor. The "performance" refers to the assay's output itself, which is then interpreted by a human user (e.g., laboratory technician, physician) in the context of the patient. However, it's not "algorithm-only" in the AI/ML sense. It's a chemical assay.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For positive confirmation: Gas Chromatography/Mass Spectrometry (GC/MS) was used as the reference (confirmatory) method.
- For comparison/equivalence: The predicate device, Emit® II Phencyclidine Assay, served as the comparative method.
- For "known" samples: Spiked samples with known concentrations of phencyclidine were used.
The sample size for the training set:
- This information is not provided as this is not an AI/ML device that undergoes a 'training' phase in the conventional sense. The development of such an assay involves reagent formulation and optimization, not machine learning model training on a dataset.
How the ground truth for the training set was established:
- Not applicable. As stated above, this is not an AI/ML device. The "ground truth" during development would be established through careful analytical chemistry and formulation to ensure the assay reagents react as expected with known concentrations of phencyclidine and its metabolites.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. Manufacturer and Contact Information:

Manufacturer:	Syva Company - Dade Behring Inc20400 Mariani Ave.Cupertino, CA 95014
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Paul Rogers Contact Information: Syva Company - Dade Behring Inc. 3403 Yerba Buena Road San Jose, CA 95161-9013 Tel: 408-239-2309

2. Device Classification Name:

"Phencyclidine test system" has been classified as Class II by the Clinical Chemistry and Clinical Toxicology Devices Panel. Reference: Federal Register, Volume 52, Number 84, May 1987

3. Intended Use:

4. Device Description and Characteristics:

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.

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Comparative Analysis

The Emit® II Plus Phencyclidine Assay showed excellent correlation to the Emit ® II Phencyclidine Assay (comparative method) for the qualitative analysis. One hundred specimens were tested. Forty nine (49) samples were positive and Fifty samples were negative by both methods. The percent agreement between the Emit ® II Plus Phencyclidine Assay and the comparative method using the 25 ng/mL cutoff result was 99%. One (1) discordant sample was positive by the Emit® II Plus Phencyclidine 25 Assay and neqative by the Emit® II Phencyclidine assay was shown to have 15 ng/mL of PCP by GC/MS. The GC/MS (reference method) has a limit of quantitation (LOQ) of 2.0 ng/mL.

All positive samples and a portion of negative samples (n=20), as assessed by the Emit® II Plus assay, were analyzed by GC/MS for confirmatory (positive samples) and specificity (negative samples) purposes. The comparative analyses demonstrated a good relationship between the semiquantitative analyses and GC/MS values.

Spiked sample Recovery

The qualitative and semiguantitative attributes were assessed by determining the accuracy of recovery for the analyte in spiked samples by the Emit® II Plus Phencyclidine Assay.

For the qualitative method, known levels of phencyclidine, spiked at levels less than or equal to minus 25% of the 25 ng/mL cutoff (0 - 18.75) and spiked levels greater than or equal to plus 25% of the 25 ng/mL cutoff (31.25 - 300) were consistently distinguished as negative or positive.

The semiquantitative results for known spiked concentrations for the Emit ® II Plus Phencyclidine quantitated within 10% of the nominal concentration between 8.0 ng/mL and 90 na/mL.

Precision

A precision study was performed on the 25 ng/mL cut off level using the Emit® II Plus Phencyclidine Assay in both the qualitative and semi quantitative modes. Acceptable within run and total precision statistics in both the qualitative and the semiquantitative assays were observed.

In the qualitative mode the with-in run precision demonstrated coefficients of variations (%CV) for controls and cutoff (rates) at 0.5 % and the total precision with % CV's for controls and cutoff (rates) ranged from 0.5 to 0.6%.

In the semiquantitative mode the with-in run precision demonstrated coefficient of variation (%CV) for controls and cutoff (concentrations) ranged from 1.79 to 2.44% and total precision %CV ranged from 2.18 to 2.60%.

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5. Substantial Equivalence:

In conclusion, Syva Company- Dade Behring Inc. considers the Emit® II Plus Phencyclidine Assay to be substantially equivalent to the Emit® II Phencyclidine Assay with regard to intended use, assay sample, and overall performance characteristics.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of four human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 7 2000

Mr. Paul L. Rogers, Jr. Senior Manager, Regulatory Affairs Syva Company - Dade Behring Inc. 3403 Yerba Buena Road P.O. Box 49013 San Jose, California 95161-9013

Re: K993983

Trade Name: Emit® II Plus Phencyclidine Assay Regulatory Class: II Product Code: LCM Dated: November 24, 1999 Received: November 24, 1999

Dear Mr. Rogers:

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

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/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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K993983

Device Name: Emit® II Plus Phencyclidine Assay

Indications for Use:

The Emit® II Plus Phencyclidine Assay is a homogeneous drugs-of-abuse enzyme immunoassay with a 25 ng/mL cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of phencyclidine in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.

Dean Coogey

(Division Sigr)
Division of Cical Laboratory Levices
510(k) Numb K993983

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.1

Over-The-Counter Use
(Optional Format 1-2-96)

Device Name: Emit® II Plus Phencyclidine Assay

Regulation Number and Section

N/A