(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 any other section of the summary. The mechanism of action is purely biochemical and optical.
No
This device is an in vitro diagnostic device intended for qualitative determination of amphetamine in human oral fluid, indicating it is for diagnostic purposes, not therapeutic intervention.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "This in vitro diagnostic device is intended for clinical laboratory use only." The purpose of the device is to determine the presence of amphetamine, which is a diagnostic function.
No
The device is an in vitro diagnostic assay that involves chemical reactions and uses a physical collection system (Oral-Eze™ Saliva Collection System) and a spectrophotometer (MGC 240) for measurement. It is not solely software.
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 qualitative determination of amphetamine in human oral fluid using an immunoassay. This is a laboratory test performed on a biological sample to provide information about a person's health status (in this case, the presence of a drug).
- Intended Use: The intended use is for clinical laboratory use, which is a common setting for IVDs.
- Regulatory Context: The mention of a predicate device (K051579) indicates that this device is likely undergoing or has undergone regulatory review as an IVD.
Therefore, based on the provided text, the CEDIA® Amphetamine OFT Assay is clearly identified as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CEDIA® Amphetamine OFT Assay is intended for use in the qualitative determination of amphetamine in human oral fluid at a cutoff concentration of 150 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze ™ Saliva Collection System. The assay is calibrated against d-amphetamine and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Amphetamine 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 Liguid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to anv drug of abuse test result particularly when preliminary positive results are used.
Product codes (comma separated list FDA assigned to the subject device)
DKZ
Device Description
The CEDIA® Amphetamine OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ßgalactosidase, 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 assay format, cleaves 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 of ß-qalactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-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 drug present in the sample.
The Oral-Eze™ Saliva Collection System consists of Oral-Eze™ saliva 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 (human)
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. clinical laboratory use only.
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.
Amphetamine Method Comparison: The overall concordance between the CEDIA® Amphetamine OFT Assay and GC/MS is 100.0%. The comparison of sample results by the CEDIA® Amphetamine 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): 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
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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: K101745
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
February 14, 2011
Requlatory Declarations
| Common / Usual Name | CEDIA® Amphetamine OFT Assay |
|---|---|
| Trade/ Proprietary Name | Thermo CEDIA® Amphetamine OFT Assay |
| Classification Regulation | 21 CFR 862.3100 |
| Device Class | Class II |
| Device Regulation Panel | Toxicology |
| Product Code | DKZ |
Intended use
The CEDIA® Amphetamine OFT Assay is intended for use in the qualitative determination of amphetamine in human oral fluid at a cutoff concentration of 150 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze ™ Saliva Collection System. The assay is calibrated against d-amphetamine and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Amphetamine 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 Liguid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to anv drug of abuse test result particularly when preliminary positive results are used.
1
Conditions for use
The CEDIA® Amphetamine OFT Assay is for prescription professional use only in clinical chemistry laboratories. It is not for use in Point of Care settings.
Legally marketed device to which equivalency is claimed
CEDIA® Amphetamine OFT Assay is substantially equivalent to the previously cleared Immunalysis Amphetamine ELISA for Oral Fluids (K051579).
DESCRIPTION OF DEVICE
Principle of the CEDIA® Amphetamine OFT Assay
The CEDIA® Amphetamine OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ßgalactosidase, 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 assay format, cleaves 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 of ß-qalactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-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 drug present in the sample.
Principle of Oral-Eze™ Saliva Collection System
The Oral-Eze™ Saliva Collection System consists of Oral-Eze™ saliva 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® Amphetamine OFT Assay is substantially equivalent to the previously cleared Immunalysis Amphetamine ELISA for Oral Fluids (K051579).
| Comparison | Proposed Device
CEDIA® Amphetamine OFT Assay | Predicate Device
Immunalysis Amphetamine ELISA
for Oral Fluids, K051579 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The CEDIA® Amphetamine OFT
Assay is intended for use in the
qualitative determination of
amphetamine in human oral fluid at
a cutoff concentration of 150 ng/mL
in neat oral fluid. The specimen
must be collected exclusively with
the Oral-Eze™ Saliva Collection
System. The assay is calibrated
against d-amphetamine and
performed on the MGC 240. This in
vitro diagnostic device is intended
for clinical laboratory use only.
The CEDIA Amphetamine 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 Immunalysis Amphetamine
ELISA test system utilizes an
Enzyme Linked Immunoassay
(ELISA) for the qualitative detection
of Amphetamine in oral fluid
samples collected with the
Quantisal™ oral fluid collection
device using a cutoff of 50 ng/mL of
d-Amphetamine. This in-vitro
diagnostic device is intended for
clinical laboratory use only.
The Immunalysis Amphetamine
ELISA Kit for Oral Fluids provides
only a preliminary analytical rest
result. A more specific alternate
chemical method must be used in
order to obtain a confirmed
analytical result. Gas
chromatography/mass spectrometry
(GC/MS) is the preferred
confirmatory method. Clinical and
Professional judgment should be
applied to any drug of abuse test
result, particularly when preliminary
positive results are used. |
| Test
Principle | The CEDIA® Amphetamine OFT
Assay uses recombinant DNA
technology to produce a unique
homogeneous enzyme
immunoassay system. The assay is
based on the bacterial enzyme ß-
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
assay format cleaves a substrate | Enzyme-labeled drug and drug
present in the sample compete for
limited antibody binding sites.
Binding of the enzyme-labeled drug
inhibits its reaction with the
substrate, thereby influencing the
rate of absorbance change
measured by the instrument. The
rate of absorbance change is
proportional to the concentration of
drug in the sample. Concentrations
of controls and unknowns are
calculated from the standard curve.
Results are read at 450 and 620 |
| | generating a color change that can
be measured
spectrophotometrically.
In the assay, analyte in the sample
competes with analyte conjugated to
one inactive fragment of β-
galactosidase for antibody binding
site. If analyte is present in the
sample, it binds to antibody, leaving
the inactive enzyme fragments free
to form active enzyme. If analyte is
not present in the sample, antibody
binds to analyte conjugated on the
inactive fragment, inhibiting the
reassociation 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 drug present in the
sample. | nm. |
| Sample
Matrix | Oral Fluid | Oral Fluid |
| Cutoff value | 150 ng/mL in neat oral fluid | 200 ng/ml in neat oral fluid
50 ng/ml diluted sample |
| Calibrator
levels | 0, 50, 200 ng/mL | 50 ng/mL |
| Cutoff level | 50 ng/mL | 50 ng/mL |
| Unassayed
Control
levels | 25, 75 ng/mL | 25, 100 ng/mL |
3
SUMMARY OF PERFORMANCE 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.
4
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.
Amphetamine Method Comparison
The overall concordance between the CEDIA® Amphetamine OFT Assay and GC/MS is 100.0%. The comparison of sample results by the CEDIA® Amphetamine OFT Assay to GC/MS showed 100.0% sensitivity and 100.0% specificity.
Conclusion
As summarized, the CEDIA® Amphetamine OFT Assay is substantially equivalent to the Immunalysis Amphetamine ELISA 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.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circular border.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Microgenics Corporation c/o Lisa Charter Manager, Regulatory Affairs 46360 Fremont Blvd. Fremont, CA 94538
APR 0 8 2011
Re: K101745
Trade Name: Thermo Scientific CEDIA Amphetamine OFT Assay Regulation Number: 21 CFR §862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ 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 tollfire mo (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
7
Indications for Use
510(k) Number (if known): K101745
Device Name: Thermo Scientific CEDIA® Amphetamine OFT Assay
Indication for Use:
The CEDIA® Amphetamine OFT Assay is intended for use in the qualitative determination of amphetamine in human oral fluid at a cutoff concentration of 150 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against d-amphetamine and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Amphetamine 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 X (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) K101745