(223 days)
Not Found
No
The device description and performance studies focus on a homogeneous enzyme immunoassay and standard analytical methods (spectrophotometry, GC/MS). There is no mention of AI, ML, or related concepts in the provided text.
No
A therapeutic device is used to treat or cure a disease or condition. This device is an assay for detecting amphetamine and methamphetamine in human urine, which is a diagnostic tool, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for the "qualitative or semi-quantitative determination of amphetamine and methamphetamine in human urine" and provides a "preliminary analytical test result." This indicates its use in aiding diagnosis or screening for substances in a clinical context, which aligns with the definition of a diagnostic device.
No
The device description clearly states it is a "liquid ready-to-use homogeneous enzyme immunoassay," which is a chemical reagent kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the assay is for the "qualitative or semi-quantitative determination of amphetamine and methamphetamine in human urine." This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Device Description: The description details a "homogeneous enzyme immunoassay" that uses antibodies and measures enzyme activity spectrophotometrically. This is a common method used in in vitro diagnostic tests.
- Performance Studies: The document describes performance studies including precision, method comparison (comparing to GC/MS), and dilution recovery, which are standard evaluations for IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K943993) indicates that this device is being compared to a previously cleared device, which is a process specific to the regulatory pathway for IVD devices. The predicate device name, "CEDIA® DAU Amphetamines Assay," also clearly indicates an in vitro diagnostic assay.
N/A
Intended Use / Indications for Use
The DRI Amphetamines Assay is intended for the qualitative or semi-quantitative determination of amphetamine and methamphetamine in human urine. The assay has cutoff levels of 500 and 1000 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting amphetamine and methamphetamine in urine on automated clinical analyzers. The assay is calibrated with methamphetamine.
This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a con firmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Product codes
DKZ, LAF
Device Description
The DRI Amphetamines Assay is a liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies, which can detect amphetamine and/or methamphetamine in urine with minimal cross-reactivity to various over-the-counter structurally unrelated compounds. The assay is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the drug from the urine sample for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the specific antibody binds the drug labeled with G6PDH and causes a decrease in enzyme activity. In the presence of free drug, the free drug occupies the antibody binding sites, allowing the drug-labeled G6PDH to interact with the substrate, resulting in enzyme activity. This phenomenon creates a direct relationship between drug concentration in urine and the enzyme activity. The enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Precision and Accuracy: Samples spiked with d-amphetamine and d-methamphetamine were tested for precision in qualitative and semi-quantitative assays following a randomized CLSI protocol. The precision study met the design specifications in both the qualitative and semi-quantitative assays. In the qualitative study, all negative samples recovered as negative and all positive samples recovered as positive. In the semi-quantitative study, the within run %CV for was less than or equal to 6.2% and the total run %CV was less than or equal to 6.9%.
Method Comparison: Samples were tested by DRI qualitative and semi-quantitative assay and compared to GC/MS. The method comparison exhibited results greater than 96% total agreement between the DRI methods and GC/MS for both qualitative and semi-quantitative assays. Discordant results were obtained when the assay was used to detect amphetamine and methamphetamine analytes individually. The assay detects the presence of both amphetamine and methamphetamine analytes with 100% cross reactivity to both drugs. Therefore samples tested for one analyte may appear discordant due to the presence of the other analyte. The method comparison results meet the design input specifications.
Dilution Recovery: Samples were tested to demonstrate linearity throughout the assay range. Results showed that recovery was less than ±4% error of the expected value for levels tested from 0 to 2000 ng/ml. The results met the design input specification for levels tested throughout the assay range, and the assay dilutes in a linear fashion.
On-Board Open Vial reagent Stability: Uncapped reagents were stored in an analyzer and all calibrators and controls were tested in qualitative and semi-quantitative assay. Reagents stored on the analyzer are stable for a minimum of 60 days.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92
The assigned 510(k) number is: K093114
COMPANY/CONTACT PERSON
Hewuan Takkele Regulatory Affairs Specialist Microgenics Corporation Thermo Fisher Scientific, Clinical Diagnostics Division 46360 Fremont Blvd. Fremont, CA 94538 (510) 979-5000 x31860 Office (510) 979-5422 Fax Hewuan.Takkele@thermofisher.com
DATE PREPARED
May 10, 2010
DEVICE NAME
| Trade Name: | Thermo Scientific DRI® Amphetamines Assay |
|---|---|
| Common Name: | DRI® Amphetamines Assay |
| Device Classification: | Amphetamine test system, Methamphetamine Test System |
| Regulation number: | 21 CFR 862.3100, 21 CFR 862.3610 |
| Product Code: | DKZ, LAF |
INTENDED USE
The DRI Amphetamines Assay is intended for the qualitative or semi-quantitative determination of amphetamine and methamphetamine in human urine. The assay has cutoff levels of 500 and 1000 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting amphetamine and methamphetamine in urine on automated clinical analyzers. The assay is calibrated with methamphetamine.
This assay provides only a preliminary analytical test result. A more specific alternative 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 consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
SUBSTANTIALLY EQUIVILANT PREDICATE DEVICE
Thermo Scientific DR1° Amphetamines Assay is substantially equivalent to the previously cleared CEDIA® DAU Amphetamines Assay (K943993).
1
SUMMARY AND EXPLANATION OF THE TEST
Amphetamines are synthetic derivatives of ephedrine. The most common amphetamines include d-amphetamine, d-methamphetamine, and d, I-amphetamine. They act as stimulants for the central nervous system. Amphetamine is the most sympathomimetic amine. When amphetamine is ingested, it is either
rapidly deactivated in the liver or excreted unchanged into the urine. Other ephedrine derivatives such as methamphetamine can be metabolized and excreted in urine as amphetamine.
The DRI Amphetamines Assay is a liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies, which can detect amphetamine and/or methamphetamine in urine with minimal cross-reactivity to various over-the-counter structurally unrelated compounds. The assay is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the drug from the urine sample for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the specific antibody binds the drug labeled with G6PDH and causes a decrease in enzyme activity. In the presence of free drug, the free drug occupies the antibody binding sites, allowing the drug-labeled G6PDH to interact with the substrate, resulting in enzyme activity. This phenomenon creates a direct relationship between drug concentration in urine and the enzyme activity. The enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.
| Comparison | CEDIA® Amphetamines Assay (K943993) | Thermo Scientific
DRI® Amphetamines Assay (K093114) |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The CEDIA® Amphetamines assay is an in-vitro
diagnostic medical device intended for the qualitative
and semi quantitative assay of amphetamines in
human urine.
The assay provides only a preliminary analytical test
result. A more specific alternative chemical method
must be used to obtain a confirmed analytical result.
Gas chromatography/mass spectrometry (GC/MS) is
the preferred confirmatory method.1 Clinical
consideration and professional judgment should be
applied to any drug of abuse test result particularly
when preliminary positive results are used. | The DRI Amphetamines Assay is intended for the
qualitative or semi-quantitative determination of
amphetamine and methamphetamine in human
urine. The assay has cutoff levels of 500 and 1000
ng/mL. The assay provides a simple and rapid
analytical screening procedure for detecting
amphetamine and methamphetamine in urine on
automated clinical analyzers. The assay is
calibrated with methamphetamine.
This assay provides only a preliminary analytical
test result. A more specific alternative 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
consideration and professional judgment should be
applied to any drug of abuse test result, particularly
when preliminary positive results are used. |
| Test
Principle | The CEDIA Amphetamines assay uses recombinant
DNA technology (US Patent No. 4708929)
to produce a unique homogeneous enzyme
immunoassay system.7 This assay is based on
the bacterial enzyme β-galactosidase, which has
been genetically engineered into two inactive
fragments. 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, drug in the sample competes with drug
conjugated to one inactive fragment of | The DRI Amphetamines Assay is a liquid ready-to-
use homogeneous enzyme immunoassay. The
assay uses specific antibodies, which can detect
amphetamine and/or methamphetamine in urine
with minimal cross-reactivity to various over-the-
counter structurally unrelated compounds. The
assay is based on the competition of an enzyme
glucose-6-phosphate dehydrogenase (G6PDH)
labeled drug and the drug from the urine sample for
a fixed amount of specific antibody binding sites. In
the absence of free drug from the sample, the
specific antibody binds the drug labeled with |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
2
| | ß-galactosidase for antibody binding site. If drug is
present in the sample, it binds to antibody,
leaving the inactive enzyme fragments free to form
active enzyme. If drug is not present in
the sample, antibody binds to drug conjugated on the
inactive fragment, inhibiting the reassociation of
inactive ß-galactosidase fragments, and no active
enzyme will be formed.
The amount of active enzyme formed and resultant
absorbance change are proportional to
the amount of drug present in the sample. | G6PDH and causes a decrease in enzyme activity.
In the presence of free drug, the free drug occupies
the antibody binding sites, allowing the drug-
labeled G6PDH to interact with the substrate,
resulting in enzyme activity. This phenomenon
creates a direct relationship between drug
concentration in urine and the enzyme activity. The
enzyme activity is determined
spectrophotometrically at 340 nm by measuring its
ability to convert nicotinamide adenine dinucleotide
(NAD) to NADH. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cutoff | 500 and 1000 ng/mL | 500 and 1000 ng/mL |
| Matrix | Human Urine | Human Urine |
| Reagents | Lyophilized | Liquid Ready-to-Use |
| | Two reagent assay (R1 and R2) | Two reagent assay (R1 and R2) |
| Calibrators | Liquid ready-to-use | Liquid ready-to-use |
| | (0, 500, 1000, 3000, 5000 ng/mL) | (0, 500, 1000, 1500, 2000 ng/mL) |
| Controls | Liquid ready-to-use | Liquid ready-to-use |
| | (375 and 625, 750 and 1250 ng/mL) | (375 and 625, 750 and 1250 ng/mL) |
| Storage
Condition | 2-8°C | 2-8°C |
PERFORMANCE TESTING SUMMARY
Precision and Accuracy
Samples spiked with d-amphetamine and d-methamphetamine were tested for precision in qualitative and semi-quantitative assays following a randomized CLSI protocol. The precision study met the design specifications in both the qualitative and semi-quantitative assays. In the qualitative study, all negative samples recovered as negative and all positive samples recovered as positive. In the semi-quantitative study, the within run %CV for was less than or equal to 6.2% and the total run %CV was less than or equal to 6.9%.
Method Comparison
Samples were tested by DRI qualitative and semi-quantitative assay and compared to GC/MS. The method comparison exhibited results greater than 96% total agreement between the DRI methods and GC/MS for both qualitative and semi-quantitative assays. Discordant results were obtained when the assay was used to detect amphetamine and methamphetamine analytes individually. The assay detects the presence of both amphetamine and methamphetamine analytes with 100% cross reactivity to both drugs. Therefore samples tested for one analyte may appear discordant due to the presence of the other analyte.
The method comparison results meet the design input specifications.
3
Dilution Recovery
Samples were tested to demonstrate linearity throughout the assay range. Results showed that recovery was less than ±4% error of the expected value for levels tested from 0 to 2000 ng/ml.. The results met the design input specification for levels tested throughout the assay range, and the assay dilutes in a linear fashion.
On-Board Open Vial reagent Stability
Uncapped reagents were stored in an analyzer and all calibrators and controls were tested in qualitative and semi-quantitative assay. Reagents stored on the analyzer are stable for a minimum of 60 days.
CONCLUSION
As summarized, the Thermo Scientific DRI® Amphetamines Assay is substantially equivalent to the CEDIA® Amphetamines Assay. Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Microgenics, Inc. C/O Hewuan Takkele 46360 Fremont Blvd. Fremont, CA 94538
Re: K093114
Trade/Device Name: DRI Amphetamines Assay Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, LAF Dated: May 7, 2010 Received: May 10, 2010
MAY 1 2 2010
Dear Ms. Takkele:
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 class II (Special Controls), 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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
5
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. 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
6
Indication for Use
510(k) Number (if known): K093114
Device Name: DRI® Amphetamines Assay
Indication for Use:
The DRI Amphetamines Assay is intended for the qualitative or semi-quantitative determination of amphetamine and methamphetamine in human urine. The assay has cutoff levels of 500 and 1000 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting amphetamine and methamphetamine in urine on automated clinical analyzers. The assay is calibrated with methamphetamine.
This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a con firmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. 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)
Division State Officer
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093114