(290 days)
K/DEN number and list them here in a comma separated list exactly as they appear in the text:
Not Found
No
The description focuses on a homogeneous enzyme immunoassay system based on recombinant DNA technology and spectrophotometric measurement. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic (IVD) device used for the qualitative determination of phencyclidine (PCP) in human oral fluid, which identifies the presence of a substance but does not treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic device is intended for clinical laboratory use only." The description of its function as a qualitative determination of phencyclidine in human oral fluid also aligns with the definition of a diagnostic device.
No
The device is an in vitro diagnostic assay that relies on chemical reactions and spectrophotometric measurement, not software processing of data as its primary function. It is a reagent kit used with a specific collection system and analyzer.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This in vitro diagnostic device is intended for clinical laboratory use only."
- Nature of the Test: The device performs a test on a human specimen (oral fluid) in vitro (outside the body) to determine the presence of a substance (phencyclidine). This is the fundamental definition of an in vitro diagnostic.
- Clinical Laboratory Use: The intended use specifies clinical laboratory use, which is a common setting for IVDs.
N/A
Intended Use / 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.
Product codes
LCM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human oral fluid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription professional use only in clinical chemistry laboratories. Not for use in Point of Care settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 overall concordance between the CEDIA® PCP OFT Assay to GC/MS showed 100.0 % sensitivity and 100.0 % specificity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 100.0 %
Specificity: 100.0 %
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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.
1
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
CEDIA® Phencyclidine (PCP) OFT
Assay | Predicate Device
OTI PCP Intercept® MICRO-PLATE
EIA
K000399 |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The OTI PCP Intercept® MICRO-
PLATE EIA is intended for use by
clinical laboratories in the qualitative
determination of PCP in oral fluid
collected with the Intercept® Drugs
of Abuse (DOA) Oral Specimen
Collection Device. FOR IN VITRO
DIAGNOSTIC USE.
The OTI PCP Intercept® MICRO-
PLATE EIA provides only a
preliminary analytical test result. A
more specific alternative chemical
method should be used in order to
obtain a confirmed analytical result.
Gas Chromatography/mass
spectrometry (GC/MS/MS) is the
preferred confirmatory method. This
is a confirmation method that is
currently pending SAMHSA
acceptance. Clinical consideration
and professional judgment should
be applied to any drugs of abuse
test result, particularly when a
preliminary, positive result is
observed. |
| Test
Principle | 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. | The OTI PCP Intercept® MICRO-
PLATE EIA is a competitive micro-
plate immunoassay for the detection
of PCP in oral fluid collected with
the Intercept® DOA Oral Specimen
Collection Device. Specimen or
standard is added to an EIA well in
combination with an enzyme labeled
hapten derivative. In an EIA well
containing an oral fluid specimen
positive for PCP, there is a
competition between the drug and
the enzyme labeled hapten to bind
the antibody fixed onto the EIA well.
EIA wells are then washed. |
2
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.
3
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).
4
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
5
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