← Product Code LCM · K101746

# THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY (K101746)

_Microgenics Corp. · LCM · Apr 8, 2011 · CH · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K101746

## Device Facts

- **Applicant:** Microgenics Corp.
- **Product Code:** LCM
- **Decision Date:** Apr 8, 2011
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** CH

## Intended Use

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 3.0 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 MGC240. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA® 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 Story

Assay detects phencyclidine (PCP) in human oral fluid; requires Oral-Eze Saliva Collection System for specimen collection. Operates on MGC240 analyzer. Homogenous enzyme immunoassay (CEDIA) uses recombinant DNA-derived beta-galactosidase fragments; analyte in sample competes with PCP-conjugated enzyme donor for antibody binding sites. Active enzyme formation produces color change proportional to analyte concentration. Used in clinical laboratories; results are preliminary and require confirmation by GC/MS or LC-MS-MS. Assists clinicians in identifying potential drug use; professional judgment required for interpretation.

## Clinical Evidence

Bench testing only. Precision studies (n=50 per concentration) evaluated performance across range of -75% to +200% of cutoff. Method comparison studies (n=40 and n=81) against LC-MS/MS showed 100% agreement for both positive and negative results. Analytical specificity evaluated against structurally related compounds and common medications; no significant interference observed.

## Technological Characteristics

Homogenous enzyme immunoassay (CEDIA). Reagents: lyophilized mouse monoclonal anti-PCP antibody, enzyme acceptor, enzyme donor conjugated to PCP derivative, chlorophenol red-beta-D-galactopyranoside. Instrument: MGC240 analyzer. Matrix: Oral fluid collected via Oral-Eze system (includes preservative buffer, ~1/3 dilution). Stability: 24 months at 2-8°C; 60 days on-board. Qualitative detection.

## Predicate Devices

- STC PCP Intercept Micro-plate EIA, OTI, Orasure Technologies Inc (k000399)

## Submission Summary (Full Text)

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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

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.

#### 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 Device<br>CEDIA® Phencyclidine (PCP) OFT<br>Assay                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | Predicate Device<br>OTI PCP Intercept® MICRO-PLATE<br>EIA<br>K000399                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use      | The CEDIA® Phencyclidine (PCP)<br>OFT Assay is intended for use in the<br>qualitative determination of<br>phencyclidine in human oral fluid at<br>a cutoff concentration of 3 ng/mL in<br>neat oral fluid. The specimen must<br>be collected exclusively with the<br>Oral-Eze™ Saliva Collection<br>System. The assay is calibrated<br>against PCP and performed on the<br>MGC 240. This <i>in vitro</i> diagnostic<br>device is intended for clinical<br>laboratory use only.<br>The CEDIA Phencyclidine (PCP)<br>OFT Assay provides only a<br>preliminary analytical test result. A<br>more specific alternative method<br>must be used to obtain a confirmed<br>analytical result. Gas<br>Chromatography/Mass<br>Spectrometry (GC/MS) and Liquid<br>Chromatography-Tandem Mass<br>Spectrometry (LC-MS/MS) are the<br>preferred confirmatory methods.<br>Clinical consideration and<br>professional judgment should be<br>applied to any drug of abuse test<br>result particularly when preliminary<br>positive results are used. | The OTI PCP Intercept® MICRO-<br>PLATE EIA is intended for use by<br>clinical laboratories in the qualitative<br>determination of PCP in oral fluid<br>collected with the Intercept® Drugs<br>of Abuse (DOA) Oral Specimen<br>Collection Device. FOR <i>IN VITRO</i><br>DIAGNOSTIC USE.<br>The OTI PCP Intercept® MICRO-<br>PLATE EIA provides only a<br>preliminary analytical test result. A<br>more specific alternative chemical<br>method should be used in order to<br>obtain a confirmed analytical result.<br>Gas Chromatography/mass<br>spectrometry (GC/MS/MS) is the<br>preferred confirmatory method. This<br>is a confirmation method that is<br>currently pending SAMHSA<br>acceptance. Clinical consideration<br>and professional judgment should<br>be applied to any drugs of abuse<br>test result, particularly when a<br>preliminary, positive result is<br>observed. |
| Test<br>Principle | Microgenics CEDIA® PCP OFT<br>Assay uses recombinant DNA<br>technology to produce a unique<br>homogeneous enzyme<br>immunoassay system. The assay is<br>based on the bacterial enzyme β-<br>galactosidase, which has been<br>genetically engineered into two<br>inactive fragments. These fragments<br>spontaneously re-associate to form<br>fully active enzyme that, in the<br>assay format, cleave a substrate,<br>generating a color change that can<br>be measured<br>spectrophotometrically.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | The OTI PCP Intercept® MICRO-<br>PLATE EIA is a competitive micro-<br>plate immunoassay for the detection<br>of PCP in oral fluid collected with<br>the Intercept® DOA Oral Specimen<br>Collection Device. Specimen or<br>standard is added to an EIA well in<br>combination with an enzyme labeled<br>hapten derivative. In an EIA well<br>containing an oral fluid specimen<br>positive for PCP, there is a<br>competition between the drug and<br>the enzyme labeled hapten to bind<br>the antibody fixed onto the EIA well.<br>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:

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.

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

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