The CEDIA® Phencyclidine (PCP) OFT Assay is intended for use in the qualitative determination of phencyclidine in human oral fluid at a cutoff concentration of 3 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against PCP and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Phencyclidine (PCP) OFT Assay provides only a preliminary analytical test result. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result particularly when preliminary positive results are used.

Device Description

Microgenics CEDIA® PCP OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzyme that, in the assay format, cleave a substrate, generating a color change that can be measured spectrophotometrically.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the CEDIA® Phencyclidine (PCP) OFT Assay:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria (e.g., "sensitivity must be >95%"). Instead, it describes performance in qualitative terms. However, based on the stated "Method Comparison" results, we can infer the implicit acceptance criteria that the device should demonstrate high concordance, sensitivity, and specificity with a confirmed method.

Acceptance Criteria (Inferred from study results)	Reported Device Performance (CEDIA® PCP OFT Assay)
Accurate recovery of samples below cutoff (negative)	All samples below cutoff read as negative.
Accurate recovery of samples above cutoff (positive)	All samples above cutoff read as positive.
Accurate recovery of low control (negative)	Low control read as negative.
Accurate recovery of high control (positive)	High control read as positive.
No significant interference from endogenous/exogenous substances	No significant interference observed.
No significant cross-reactivity with unrelated compounds	No significant cross-reactivity observed.
High overall concordance with GC/MS or LC-MS/MS	100.0 % concordance with GC/MS.
High sensitivity compared to GC/MS or LC-MS/MS	100.0 % sensitivity to GC/MS.
High specificity compared to GC/MS or LC-MS/MS	100.0 % specificity to GC/MS.

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

The document does not explicitly state the sample size used for the test set in the "Method Comparison" study that determined 100% concordance, sensitivity, and specificity. It also does not specify the country of origin for the data or whether it was retrospective or prospective.

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

The document does not mention the use of human experts to establish ground truth for the test set. Instead, the ground truth was established by confirmatory analytical methods (GC/MS).

4. Adjudication Method for the Test Set:

Not applicable. The ground truth was established through analytical methods (GC/MS), not through expert review requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant.

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

Yes, the studies presented are standalone performance evaluations of the assay itself. The "Method Comparison" directly compares the device's output to the gold standard (GC/MS) without human interpretation as an intermediate step.

7. The Type of Ground Truth Used:

The ground truth used for the "Method Comparison" study was Gas Chromatography/Mass Spectrometry (GC/MS). The document also mentions Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) as an alternative preferred confirmatory method.

8. The Sample Size for the Training Set:

The document does not explicitly state the sample size used for any training set. This is typical for an immunoassay, as it's not a machine learning model that undergoes explicit "training" on a dataset in the same way. The assay's performance is established through analytical validation studies on samples.

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

Not applicable in the context of "training set" for a machine learning model. For the assay's development and validation, the ground truth for samples used in analytical studies (e.g., precision, cutoff characterization, interference, specificity) would have been established through controlled spiking of known concentrations or independent confirmatory methods such as GC/MS for validation of spiked samples. The document implies that the assay was calibrated against PCP.

Summary

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510K SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is: K101746

APR - 8 2011

Company/Contact person

Lisa Charter Manager, Regulatory Affairs Thermo Fisher Scientific, Clinical Diagnostic Division 46360 Fremont Blvd Fremont, CA 94538 Phone: (510) 979-5142 Facsimile: (510) 979-5422 Email: Lisa.Charter@ThermoFisher.com

Date Prepared

March 10, 2011

Regulatory Declarations

Common / Usual Name	CEDIA® Phencyclidine (PCP) OFT Assay
Trade/ Proprietary Name	Thermo Scientific CEDIA® Phencyclidine (PCP) OFT Assay
Classification Regulation	21 CFR 862.3100
Device Class	Class II
Device Regulation Panel	Toxicology
Product Code	LCM

Intended use

Conditions for use

The CEDIA® Phencyclidine (PCP) OFT Assay is for prescription professional use only in clinical chemistry laboratories. It is not for use in Point of Care settings.

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Comparison of Technological Characteristics

CEDIA® Phencyclidine (PCP) OFT Assay is substantially equivalent to the previously
cleared STC PCP Intercept® MICRO-PLATE EIA, K000399 (At present OTI, OraSure Technologies Inc.)

Comparison	Subject DeviceCEDIA® Phencyclidine (PCP) OFTAssay	Predicate DeviceOTI PCP Intercept® MICRO-PLATEEIAK000399
Intended Use	The CEDIA® Phencyclidine (PCP)OFT Assay is intended for use in thequalitative determination ofphencyclidine in human oral fluid ata cutoff concentration of 3 ng/mL inneat oral fluid. The specimen mustbe collected exclusively with theOral-Eze™ Saliva CollectionSystem. The assay is calibratedagainst PCP and performed on theMGC 240. This in vitro diagnosticdevice is intended for clinicallaboratory use only.The CEDIA Phencyclidine (PCP)OFT Assay provides only apreliminary analytical test result. Amore specific alternative methodmust be used to obtain a confirmedanalytical result. GasChromatography/MassSpectrometry (GC/MS) and LiquidChromatography-Tandem MassSpectrometry (LC-MS/MS) are thepreferred confirmatory methods.Clinical consideration andprofessional judgment should beapplied to any drug of abuse testresult particularly when preliminarypositive results are used.	The OTI PCP Intercept® MICRO-PLATE EIA is intended for use byclinical laboratories in the qualitativedetermination of PCP in oral fluidcollected with the Intercept® Drugsof Abuse (DOA) Oral SpecimenCollection Device. FOR IN VITRODIAGNOSTIC USE.The OTI PCP Intercept® MICRO-PLATE EIA provides only apreliminary analytical test result. Amore specific alternative chemicalmethod should be used in order toobtain a confirmed analytical result.Gas Chromatography/massspectrometry (GC/MS/MS) is thepreferred confirmatory method. Thisis a confirmation method that iscurrently pending SAMHSAacceptance. Clinical considerationand professional judgment shouldbe applied to any drugs of abusetest result, particularly when apreliminary, positive result isobserved.
TestPrinciple	Microgenics CEDIA® PCP OFTAssay uses recombinant DNAtechnology to produce a uniquehomogeneous enzymeimmunoassay system. The assay isbased on the bacterial enzyme β-galactosidase, which has beengenetically engineered into twoinactive fragments. These fragmentsspontaneously re-associate to formfully active enzyme that, in theassay format, cleave a substrate,generating a color change that canbe measuredspectrophotometrically.	The OTI PCP Intercept® MICRO-PLATE EIA is a competitive micro-plate immunoassay for the detectionof PCP in oral fluid collected withthe Intercept® DOA Oral SpecimenCollection Device. Specimen orstandard is added to an EIA well incombination with an enzyme labeledhapten derivative. In an EIA wellcontaining an oral fluid specimenpositive for PCP, there is acompetition between the drug andthe enzyme labeled hapten to bindthe antibody fixed onto the EIA well.EIA wells are then washed.

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SUMMARY OF CLINICAL TESTING

Qualitative Precision

All samples tested recovered accurately. Samples at levels below the cutoff read as negative and samples at levels above the cutoff read as positive.

Qualitative Cutoff Characterization

All samples tested recovered accurately, low control as negative and high control level as positive.

Interferences

Results demonstrated that there was no significant interference from endogenous and exogenous substances in oral fluid at the tested concentrations and in samples adjusted to pH range of 5 to 9.

Specificity and Cross-Reactivity

Cross-reactivity to metabolites and structurally related compounds was tested in the assay. No significant cross-reactivity was observed with other structurally unrelated compounds.

Method Comparison

The overall concordance between the CEDIA® PCP OFT Assay and GC/MS is 100.0 %. The The overall denoordance betwoorhane EDIA® PCP OFT Assay to GC/MS showed 100.0 % sensitivity and 100.0 % specificity.

Conclusion

As summarized, the CEDIA® PCP OFT Assay is substantially equivalent to the OTI PCP Intercept® MICRO-PLATE EIA for oral fluid. Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied.

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Image /page/3/Picture/0 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 a stylized emblem that resembles a bird or abstract human figure, composed of flowing lines.

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

Microgenies Corp. c/o Lisa Charter 46360 Fremont Blvd. Fremont, CA 94538

APR 0 8 2011

Re: K101746

Trade Name: Thermo Scientific CEDIA Phencyclidine (PCP) OFT Assay Regulation Number: 862.3100 Regulatory Class: Unclassified Product Codes: LCM Dated: March 10, 2011 Received: March 14, 2011

Dear Ms. Charter:

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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Page 2 --

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.

Courtney 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

510(k) Number (if known): K101746

Device Name: CEDIA® Phencyclidine (PCP) OFT Assay

Indications for Use:

Prescription Use × (21 CFR Part 801 Subpart D) Over the Counter Use

(21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

And/Or

Carol C. Benson

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

510(k) K101746

Regulation Number and Section

N/A