ORAL FLUID PHENCYCLIDINE by Roche Diagnostics

DAT Oral Fluid Phencyclidine (OFMA) is an in vitro diagnostic test for the qualitative and semiquantitative detection of Phencyclidine in human oral fluid at a cutoff concentration of 6 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by a confirmatory method such as LC/MS/MS.

DAT Oral Fluid Phencyclidine provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. 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 DAT oral fluids assays are based on the kinetic interaction of microparticles in a solution (KIMS) technology. The DAT oral fluids assays are qualitative and semi-quantitative. In the absence of sample drug, soluble drug conjugates bind to antibody-bound microparticles, causing formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. When an oral fluid sample contains the drug in question, this drug competes with the drug derivative conjugate for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.

Multi-analyte calibrator and control solutions are prepared from NIST traceable. commercially available solutions. A stock solution is prepared gravimetrically and verified by LC/MS/MS. The product calibrators are prepared gravimetrically by spiking phencyclidine into a synthetic oral fluid matrix at the following concentrations: 0, 1, 2, 4, 8, and 16 ng/mL. Controls are prepared gravimetrically in a synthetic oral fluid matrix at concentrations ±50% of the cutoff. All calibrator and controls concentrations are verified by LC/MS/MS.

AI/ML Overview

Here's the analysis of the provided text regarding the acceptance criteria and study for the Oral Fluid Phencyclidine Assay (K093989):

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific pass/fail acceptance criteria or a dedicated study section detailing the device's performance against such criteria. It largely focuses on the device's description, intended use, and substantial equivalence to a predicate device.

However, based on the context of an immunoassay for drug detection, the primary performance characteristic would be accuracy (sensitivity and specificity) relative to a confirmatory method like LC/MS/MS. The document mentions that the product calibrators and controls are verified by LC/MS/MS, indicating this as a reference standard.

Given the information provided, we can infer the relevant performance characteristic and its reference.

Characteristic	Acceptance Criteria (Implied/Inferred)	Reported Device Performance (as inferred from context)
Accuracy	Not explicitly stated as a numerical threshold in this document. For an in vitro diagnostic drug assay, typical acceptance criteria would involve a high percentage agreement (e.g., >95%) with a gold standard (like LC/MS/MS) for both positive and negative samples, particularly around the stated cutoff concentration (6 ng/mL for neat oral fluid). This would include demonstrating appropriate sensitivity (detecting true positives) and specificity (correctly identifying true negatives), and potentially precision around the cutoff. The phrase "Substantially Equivalent" implies that its performance is comparable to the predicate device (PCP Intercept® MICRO-PLATE EIA (K000399)).	The document states: - "Multi-analyte calibrator and control solutions are prepared from NIST traceable, commercially available solutions." - "A stock solution is prepared gravimetrically and verified by LC/MS/MS." - "The product calibrators are prepared gravimetrically by spiking phencyclidine into a synthetic oral fluid matrix at the following concentrations: 0, 1, 2, 4, 8, and 16 ng/mL. Controls are prepared gravimetrically in a synthetic oral fluid matrix at concentrations ±50% of the cutoff." - "All calibrator and controls concentrations are verified by LC/MS/MS." These statements indicate that the verification of calibrators and controls uses LC/MS/MS, which serves as the reference for ensuring the assay's ability to detect phencyclidine at specific concentrations, including the 6 ng/mL cutoff. However, the results of a comprehensive study (e.g., sensitivity, specificity, agreement rate with LC/MS/MS on actual patient samples) are not reported in this summary.
Cutoff	Accurate detection at the specified cutoff concentration of 6 ng/mL.	The device is designed for "detection of Phencyclidine in human oral fluid at a cutoff concentration of 6 ng/mL in neat oral fluid." Calibrators are spiked at concentrations including 4 ng/mL and 8 ng/mL, surrounding the cutoff. Controls are also ±50% of the cutoff. The verification mentioned above indicates the assay is calibrated for this specific cutoff.

Study Information (Based on provided text)

The provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than detailing full study results. Therefore, many of the requested details about the study are not explicitly present in this document.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified, but given the context of in vitro diagnostic development, it would likely involve laboratory-prepared samples (spiked synthetic oral fluid) and potentially clinical samples (though no details are given). The use of NIST traceable materials suggests a controlled laboratory environment for preparation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable/not specified. The ground truth for this type of chemical assay is typically established through a highly accurate reference analytical method, not expert consensus.
- Qualifications of experts: Not applicable.
Adjudication method for the test set:
- Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations (e.g., image reading) where disagreement can occur. For chemical assays, the reference method (LC/MS/MS) provides an objective ground truth.
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 device is an in vitro diagnostic assay for detecting a chemical substance (Phencyclidine) in oral fluid. It does not involve human readers interpreting images or complex data, nor does it incorporate AI assistance in the way clinical diagnostic AI tools do.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The "device" itself (Oral Fluid Phencyclidine Assay) is a standalone biochemical test performed on an automated clinical chemistry analyzer. It functions "without human-in-the-loop performance" for the analytical measurement, although human operators are required for sample collection and loading. The results are quantitative/semi-quantitative outputs based on the chemical reaction. The document does not detail a separate "standalone study" from its general performance evaluation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Highly accurate analytical method: The ground truth for phencyclidine concentrations in oral fluid is established by LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry). This is explicitly mentioned for verifying calibrators and controls, and also as the "preferred confirmatory method" for positive assay results.
The sample size for the training set:
- Not specified. This document describes a chemical assay, not a machine learning algorithm that requires a "training set" in the typical sense. The "training" for such a device involves calibration using carefully prepared calibrators at known concentrations. The concentrations of these calibrators are listed (0, 1, 2, 4, 8, and 16 ng/mL).
How the ground truth for the training set was established:
- As noted above, for chemical assays, there isn't a "training set" in the machine learning context. The equivalent would be the calibrator and control preparation.
- The ground truth for the calibrators and controls was established gravimetrically (by precise weighing) by spiking phencyclidine into a synthetic oral fluid matrix, and then verified by LC/MS/MS. This ensures the known, accurate concentrations of the drug in these solutions.

Summary

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K093989

510(k) Summary: Oral Fluid Phencyclidine Assay

Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
SubmitterName, Address,Contact	Roche Diagnostics9115 Hague Rd.Indianapolis, IN 46250317-521-3742	JAN 25 2011
	Contact Person: Michelle NeffDate Prepared: January 27, 2011
Device Name	Proprietary name: Oral Fluid Phencyclidine Assay
	Common name: Phencyclidine test system
	Classification name: Enzyme Immunoassay, Phencyclidine
	Product Code: LCM
DeviceDescription	The DAT oral fluids assays are based on the kinetic interaction of microparticles in a solution (KIMS) technology. The DAT oral fluids assays are qualitative and semi-quantitative. In the absence of sample drug, soluble drug conjugates bind to antibody-bound microparticles, causing formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. When an oral fluid sample contains the drug in question, this drug competes with the drug derivative conjugate for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.
	Multi-analyte calibrator and control solutions are prepared from NIST traceable. commercially available solutions. A stock solution is prepared gravimetrically and verified by LC/MS/MS. The product calibrators are prepared gravimetrically by spiking phencyclidine into a synthetic oral fluid matrix at the following concentrations: 0, 1, 2, 4, 8, and 16 ng/mL. Controls are prepared gravimetrically in a synthetic oral fluid matrix at concentrations ±50% of the cutoff. All calibrator and controls concentrations are verified by LC/MS/MS.

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Intended Use	DAT Oral Fluid Phencyclidine (OFMA) is an in vitro diagnostic test for the qualitative and semiquantitative detection of Phencyclidine in human oral fluid at a cutoff concentration of 6 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by a confirmatory method such as LC/MS/MS.
	DAT Oral Fluid Phencyclidine provides only a preliminary

Intended Use

DAT Oral Fluid Phencyclidine provides only a preliminary

analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Comparison to
Predicate Device

The Oral Fluid Phencyclidine assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, we claim substantial equivalence to the currently marketed PCP Intercept® Micro-Plate EIA assay (K000399).

Feature	Roche Oral Fluid Phencyclidines Assay	Predicate Device: PCP Intercept®MICRO-PLATE EIA (K000399)
Methodology	KIMS, Kinetic interaction of microparticles insolution	Competitive micro-plate immunoassay
Sample Type	Oral Fluid	Oral Fluid
Intended Use	Qualitative and semi-quantitative detection ofPhencyclidine	Qualitative detection of Phencyclidine
Neat Cutoff	6 ng/mL	3 ng/mL
Controls	Synthetic oral fluid matrix:Zero, Negative (.5X), and Positive (1.5X)	Synthetic oral fluid matrix:Negative (.5X) and Positive (1.5X)
Calibrator	Synthetic oral fluid matrix:Zero, .5X, Cutoff, 2X, 4X, and 8X	Synthetic oral fluid matrix:Zero, Cutoff

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Image /page/2/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" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings. The emblem is black, while the text and the circle are a lighter color, possibly white or light gray.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Roche Diagnostics c/o Ms. Michelle Lee Neff 9115 Hague Road Indianapolis, IN, 46250

Re: K093989

Trade Name: DAT Oral Fluid Phencyclidine Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: LCM, DKB. DIF Dated: January 7, 2011 Received: January 24, 2011

JAN 2 5 2011

Dear Ms. Neff:

100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 -

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C.C.

Courmey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K093989

Device Name: DAT Oral Fluid Phencyclidine

Indications for Use:

Prescription Use XX AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K093989

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Indications for Use Form

510(k) Number (if known): K093989

Device Name: DAT Oral Fluid Phencyclidine

Indications for Use:

The Oral Fluid DAT Control Set A is for use as assayed controls with the DAT Oral Fluid assays on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.

The Oral Fluid DAT Qual Cal calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.

The Oral Fluid DAT SQ Cal A calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carl

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K093989

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Regulation Number and Section

N/A