(290 days)
Not Found
No
The device description and performance studies focus on a homogeneous enzyme immunoassay system based on recombinant DNA technology, with no mention of AI or ML algorithms.
No.
The device is an in vitro diagnostic device intended for qualitative determination of cocaine in human oral fluid, which is used for diagnostic purposes, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section states: "This in vitro diagnostic device is intended for clinical laboratory use only." The device aims to qualitatively determine cocaine in human oral fluid, which is a diagnostic purpose.
No
The device is an in vitro diagnostic assay that uses chemical reactions and an enzyme immunoassay system to detect cocaine in oral fluid. It is performed on a specific instrument (MGC240) and requires a physical collection system (Oral-Eze™). This clearly indicates a hardware component and a chemical/biological process, not a software-only device.
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."
- Intended Use: The device is intended for the qualitative determination of cocaine in human oral fluid, which is a biological specimen. This is a classic application of an in vitro diagnostic test.
- Clinical Laboratory Use: The intended user and care setting are clinical chemistry laboratories, which is where IVD tests are typically performed.
- Performance Studies: The document includes performance studies (Qualitative Precision, Qualitative Cutoff Characterization, Interferences, Specificity and Cross-Reactivity, Method Comparison) and key metrics (Sensitivity, Specificity), which are standard for demonstrating the performance of an IVD.
- Predicate Device: A predicate device (K001197; OTI Cocaine Metabolite Intercept® MICRO-PLATE EIA) is listed, which is a common requirement for demonstrating substantial equivalence for IVD devices seeking regulatory clearance.
Therefore, based on the provided information, the CEDIA® Cocaine OFT Assay is clearly identified and described as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CEDIA® Cocaine OFT Assay is intended for use in the qualitative determination of cocaine in human oral fluid at a cutoff concentration of 15 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against benzoylecgonine and performed on the MGC240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Cocaine 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 (comma separated list FDA assigned to the subject device)
DIO
Device Description
The CEDIA® Cocaine OFT Assay uses recombinant DNA technology (US Patent No. 4708929) 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 i.e., enzyme acceptor (EA) and enzyme donor (ED). These fragments spontaneously reassociate to form fully active enzyme that, in the presence of the substrate, produces a color change that can be measured spectrophotometrically. When the drug is present in the sample, it binds to the antibody, leaving the enzyme fragments free to reassociate and form active enzyme. This results in an increase in absorbance that is proportional to the drug concentration.
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. It is 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® Cocaine OFT Assay and GC/MS is 97.6%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The comparison of sample results by the CEDIA® Cocaine OFT Assay to GC/MS showed 97.6% sensitivity and 97.6% specificity.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
APR - 8 2011 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: K101742
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
January 6, 2011
יות האמר
Regulatory Declarations
| Common / Usual Name | CEDIA® Cocaine OFT Assay |
|---|---|
| Trade/ Proprietary Name | Thermo Scientific CEDIA® Cocaine OFT Assay |
| Classification Regulation | 21 CFR 862.3250 |
| Device Class | Class II |
| Device Regulation Panel | Toxicology |
| Product Code | DIO |
Intended use
The CEDIA® Cocaine OFT Assay is intended for use in the qualitative determination of cocaine in human oral fluid at a cutoff concentration of 15 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against benzoylecgonine and performed on the MGC240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Cocaine 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® Cocaine 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
The CEDIA® Cocaine OFT Assay is substantially equivalent to the OTI Cocaine Metabolite Intercept® MICRO-PLATE EIA. (K001197)
| Comparison | Subject Device
CEDIA® Cocaine OFT Assay | Predicate Device
OTI Cocaine Metabolite Intercept®
MICRO-PLATE EIA
K001197 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CEDIA® Cocaine OFT Assay is
intended for use in the qualitative
determination of cocaine in human
oral fluid at a cutoff concentration of
15 ng/mL in neat oral fluid. The
specimen must be collected
exclusively with the Oral-Eze™
Saliva Collection System. The
assay is calibrated against
benzoylecgonine and performed on
the MGC240. This in vitro diagnostic
device is intended for clinical
laboratory use only.
The CEDIA Cocaine 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 Cocaine Metabolite
Intercept® MICRO-PLATE EIA is
intended for use by clinical
laboratories in the qualitative
determination of cocaine and
cocaine metabolites in oral fluid
collected with the Intercept® Drugs
of Abuse (DOA) Oral Specimen
Collection Device. For In Vitro
Diagnostic Use.
The OTI Cocaine Metabolite
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/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. |
| Principle Of
the Assay | The CEDIA® Cocaine OFT Assay
uses recombinant DNA technology
(US Patent No. 4708929) 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 i.e., enzyme
acceptor (EA) and enzyme donor
(ED). These fragments
spontaneously reassociate to form
fully active enzyme that, in the | The OTI Cocaine Metabolite
Intercept® MICRO-PLATE EIA is a
competitive immunoassay for the
detection of cocaine and cocaine
metabolites in oral fluid collected
with the Intercept® 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 cocaine or
cocaine metabolites, there is a |
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® Cocaine OFT Assay and GC/MS is 97.6%. The comparison of sample results by the CEDIA® Cocaine OFT Assay to GC/MS showed 97.6% sensitivity and 97.6% specificity. - 森林
Conclusion
As summarized, the CEDIA® Cocaine OFT Assay is substantially equivalent to the OTI Cocaine Metabolite Intercept® MICRO-PLATE EIA. Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized depiction of an eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and governmental nature.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Microgenics Corp. c/o Ms. Lisa Charter Manager, Regulatory Affairs 46360 Fremont Blvd Fremont, CA 94538
APR 0 8 2011,
Re: K101742
Trade Name: Thermo Scientific CEDIA Cocaine OFT Assay Regulation Number: 21 CFR 862.3250 Regulation Name: Cocaine and cocaine metabolite test system. Regulatory Class: Class II Product Codes: DIO Dated: April 6, 2011 Received: April 7, 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 Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to paremarket 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 tolli-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,
CJC.
Courthey 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): K101742
Device Name: CEDIA® Cocaine OFT Assay
Indications for Use:
The CEDIA® Cocaine OFT Assay is intended for use in the qualitative determination of cocaine in human oral fluid at a cutoff concentration of 15 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against benzovlecgonine and performed on the MGC240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Cocaine 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) And/Or
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 (OIVD)
Carol C. Benson
Division Sian-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101742