(290 days)
Not Found
No
The device description details a homogeneous enzyme immunoassay system based on recombinant DNA technology and spectrophotometric measurement. There is no mention of AI or ML in the intended use, device description, performance studies, or key metrics. The technology described is a standard biochemical assay.
No
The device is an in vitro diagnostic device intended for the qualitative determination of Cannabinoids in human oral fluid, used for preliminary analytical testing. It does not provide therapy or treatment.
Yes
The intended use explicitly states, "This in vitro diagnostic device is intended for clinical laboratory use only," and the purpose is for the "qualitative determination of Cannabinoids in human oral fluid." These phrases indicate that the device is used to diagnose or detect the presence of a substance in the body.
No
The device description clearly outlines a chemical assay system involving reagents, a collection system with physical components (pad, handle, tube), and a spectrophotometric measurement. This is a hardware-based in vitro diagnostic device, 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."
- Purpose: The device is intended for the qualitative determination of Cannabinoids 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 is a clinical laboratory, which is where IVD tests are typically performed.
- Calibration: The mention of calibrators (CEDIA THC OFT Calibrators) further indicates it's an IVD, as calibrators are used to ensure the accuracy of diagnostic tests.
- Confirmatory Methods: The statement that the assay provides a "preliminary analytical test result" and requires a "more specific alternative method to obtain a confirmed analytical result" is common for screening IVD tests.
- Predicate Device: The mention of a predicate device (K002375; STC Cannabinoids Intercept® MICRO-PLATE EIA) which is also an IVD, supports the classification of this device as an IVD.
All these factors strongly indicate that the CEDIA® Cannabinoids OFT Assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CEDIA® Cannabinoids OFT Assay is intended for use in the qualitative determination of Cannabinoids 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 1-Δ THC and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA THC OFT Calibrators are intended for use in the calibration of I-Δ THC when used with the CEDIA Cannabinoids OFT Assay. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Cannabinoids 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)
LDJ, DLJ
Device Description
Microgenics CEDIA® Cannabinoids OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-aalactosidase, 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.
In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment (enzyme donor) of 0-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragment free to form active enzyme. If the analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the re-association of inactive B-qalactosidase fragments. and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of analyte present in the sample.
The Oral-Eze™ Saliva Collection System consists of Oral-Eze™ saliva collector and collection tube with preservative buffer. Oral-Eze™ saliva collector consists of an absorbent pad attached to a plastic handle. The saliva collector is provided with a volume adequacy indicator. The plastic handle has a round window where blue color will appear when sufficient volume of oral fluid is collected. Samples are collected by placing the collector pad and plastic shield between lower cheek and gum with the plastic shield facing the cheek. Oral fluid collection is done when blue color appears in the window of the handle. The pad is ejected in to the collection tube by placing thumb on the ridges on the handle and pushing the thumb forward. The collection tube is capped and sent to the laboratory for processing and testing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral fluid (from mouth/oral cavity)
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.
Interference: 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.
Qualitative Method Comparison: The overall concordance between the CEDIA® Cannabinoids OFT Assay and GC/MS is 98.8%.
Conclusion: As summarized, the CEDIA® Cannabinoids OFT Assay is substantially equivalent to the OTI Cannabinoids 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The comparison of sample results by the CEDIA® Cannabinoids OFT Assay to GC/MS showed 97.6% sensitivity and 100.0% 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
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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
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: K101744
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 e-Mail: Lisa.Charter@ThermoFisher.com
Date Prepared
May 15, 2010
Requlatory Declarations
| Common / Usual Name | CEDIA® Cannabinoids OFT Assay
CEDIA® THC OFT Calibrators |
|---------------------------|---------------------------------------------------------------------------|
| Trade/ Proprietary Name | Thermo CEDIA® Cannabinoids OFT Assay
Thermo CEDIA® THC OFT Calibrators |
| Classification Regulation | 21 CFR 862.3870
21 CFR 862.3200 |
| Device Class | Class II |
| Device Regulation Panel | Toxicology |
| Product Code | LDJ, DLJ |
Intended use
The CEDIA® Cannabinoids OFT Assay is intended for use in the qualitative determination of Cannabinoids 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 1-Δ THC and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA THC OFT Calibrators are intended for use in the calibration of I-Δ THC when used with the CEDIA Cannabinoids OFT Assay. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Cannabinoids 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® Cannabinoids OFT Assay is for prescription professional use only in clinical chemistry laboratories. It is not for use in Point of Care settings.
1
Legally marketed device to which equivalency is claimed
CEDIA® Cannabinoids OFT Assay is substantially equivalent to the previously cleared STC Cannabinoids Intercept® MICRO-PLATE EIA, K002375 (At present OTI, OraSure Technologies Inc.)
DESCRIPTION OF DEVICE
CEDIA® Cannabinoids OFT Assay
Microgenics CEDIA® Cannabinoids OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-aalactosidase, 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.
In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment (enzyme donor) of 0-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragment free to form active enzyme. If the analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the re-association of inactive B-qalactosidase fragments. and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of analyte present in the sample.
Principle of Oral-Eze™ Saliva Collection System
The Oral-Eze™ Saliva Collection System consists of Oral-Eze™ saliva collector and collection tube with preservative buffer. Oral-Eze™ saliva collector consists of an absorbent pad attached to a plastic handle. The saliva collector is provided with a volume adequacy indicator. The plastic handle has a round window where blue color will appear when sufficient volume of oral fluid is collected. Samples are collected by placing the collector pad and plastic shield between lower cheek and gum with the plastic shield facing the cheek. Oral fluid collection is done when blue color appears in the window of the handle. The pad is ejected in to the collection tube by placing thumb on the ridges on the handle and pushing the thumb forward. The collection tube is capped and sent to the laboratory for processing and testing.
2
Comparison of Technological Characteristics
CEDIA® Cannabinoids OFT Assay is compared below to the previously cleared STC
Cannabinoids Intercept® MICRO-PLATE EIA, K002375 (At present OTI, OraSure Technologies Inc.)
| Comparison | Subject Device
CEDIA® Cannabinoids OFT Assay | Predicate Device
OTI Cannabinoids Intercept® MICRO-PLATE EIA
K002375 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CEDIA® Cannabinoids OFT Assay is intended for use in the
qualitative determination of
Cannabinoids 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 l-Δ9 THC and performed on
the MGC 240. This in vitro
diagnostic device is intended for
clinical laboratory use only. | The OTI Cannabinoids Intercept®
MICRO-PLATE EIA is intended for
use by clinical laboratories in the
qualitative determination of
cannabinoids in oral fluid collected
with the Intercept® Drugs of Abuse
(DOA) Oral Specimen Collection
Device. For In Vitro Diagnostic Use. |
| | The CEDIA THC OFT Calibrators
are intended for use in the
calibration of I-Δ9 THC when used
with the CEDIA Cannabinoids OFT
Assay. This in vitro diagnostic
device is intended for clinical
laboratory use only. | The OTI Cannabinoids 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. |
| | The CEDIA Cannabinoids 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. | |
| Test
Principle | Microgenics CEDIA® Cannabinoids
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 | The OTI Cannabinoids Intercept®
MICRO-PLATE EIA is a competitive
immunoassay for the detection of
cannabinoids 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 |
| | 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.
In the assay, analyte in the sample
competes with analyte conjugated to
one inactive fragment (enzyme
donor) of β-galactosidase for
antibody binding site. If analyte is
present in the sample, it binds to
antibody, leaving the inactive
enzyme fragment free to form active
enzyme. If the analyte is not present
in the sample, antibody binds to
analyte conjugated on the inactive
fragment, inhibiting the re-
association of inactive β-
galactosidase fragments, and no
active enzyme is formed. The
amount of active enzyme formed
and resultant absorbance change
are directly proportional to the
amount of analyte present in the
sample. | In an EIA well containing an oral
fluid specimen positive for
cannabinoids, there is a competition
between the drug and the enzyme
labeled hapten to bind the antibody
fixed on the EIA well. EIA wells are
then washed, substrate is added,
and color is produced. The
absorbance measured for each well
at 450 nm is inversely proportional
to the amount of cannabinoids
present in the specimen or
calibrator/control. |
| Sample
Matrix | Oral Fluid | Oral Fluid |
| Calibrator
levels | 0, 1.0, 10.0 ng/mL | 0, 1.0 ng/mL |
| Cutoff level | 3.0 ng/mL in neat oral fluid | 1.0 ng/mL |
| Unassayed
Control
levels | 0.5, 1.5 ng/mL | 0.5, 2.0 ng/mL |
3
.
.
4
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.
Interference
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.
Qualitative Method Comparison
The overall concordance between the CEDIA® Cannabinoids OFT Assay and GC/MS is 98.8%. The comparison of sample results by the CEDIA® Cannabinoids OFT Assay to GC/MS showed 97.6% sensitivity and 100.0% specificity.
Conclusion
As summarized, the CEDIA® Cannabinoids OFT Assay is substantially equivalent to the OTI Cannabinoids 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.
5
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of a bird, possibly an eagle, with its wings spread. The bird is composed of several curved lines, giving it a modern and abstract appearance.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
APR 0 8 2011
Microgenics Corp. c/o Lisa Charter 46360 Fremont Blvd. Fremont, CA 94538
Re: K101744
Trade Name: Thermo Scientific CEDIA Cannabinoids OFT Assay and Thermo Scientific CEDIA THC OFT Calibrators Regulation Number: 21 CFR 862.3870 Regulatory Class: Class II Product Codes: LDJ, DLJ 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).
6
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 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 ne (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
7
Indications for Use
510(k) Number (if known): K101744
Device Name: CEDIA® Cannabinoids OFT Assay CEDIA® THC OFT Calibrators
Indications for Use:
The CEDIA® Cannabinoids OFT Assay is intended for use in the qualitative determination of Cannabinoids in human oral fluid at a cutoff concentration of 3 no/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against I-A THC and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA THC OFT Calibrators are intended for use in the calibration of I-A THC when used with the CEDIA Cannabinoids OFT Assay. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Cannabinoids 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 Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101744