(99 days)
Not Found
No
The device description details a homogeneous enzyme immunoassay based on antibody binding and spectrophotometric measurement. There is no mention of AI, ML, or any computational analysis beyond basic spectrophotometry. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No
The device is an in vitro diagnostic assay used to detect oxycodone in urine, providing preliminary analytical results for screening purposes, not for treating any condition.
Yes
This device is designed for the detection of oxycodone in human urine, providing a preliminary analytical test result which is then used to screen for substances. This function directly 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 and biological reagent-based test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative and semi-quantitative detection of oxycodone in human urine." This involves testing a sample taken from the human body in vitro (outside the body) to provide information about a physiological state (presence of oxycodone).
- Device Description: The description details an "enzyme immunoassay" that uses "specific antibodies" to detect oxycodone in a "urine sample." This is a classic description of an in vitro diagnostic test.
- Sample Type: The device analyzes "human urine," which is a biological specimen.
- Purpose: The purpose is to "detect oxycodone in human urine," which is a diagnostic activity.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DRI® Oxycodone Assay is intended for the qualitative and semi-quantitative detection of oxycodone 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. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
The DRI® Oxycodone Assay is intended to be used for the qualitative and semiquantitative determination of the presence of oxycodone in human urine at cutoffs of 100 and 300 ng/mL. The assay provides a simple and rapid analytical screening procedure to detect oxycodone in human urine.
The DRI® Oxycodone Calibrators are used to calibrate the DRI® Oxycodone Assay in human urine.
The DRI® Oxycodone Controls are used to qualify the DRI® Oxycodone Assay in human urine.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DLJ, LAS
Device Description
The DRI® Oxycodone Assay is supplied as liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect oxycodone and oxymonthone without significant cross-reactivity to other opiate compounds. The assay is based on computition between oxycodone labeled with glucose-6-phosphate dehydrogenase (G6PDH), and oxycodone present in the urine sample for a fixed amount of specific antibody binding and a necess. In the absence of free oxycodone in the sample, the specific antibody binds the drug labeled with G6PDH and causes a decrease in enzyme activity. This phenomenon creates a direct relationship between the drug concentration in urine and enzyme activity. The enzyme activity is deternined spectrophotometrically at 340 nm by measuring the conversion of 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
human urine
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)
Not Found
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
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). 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.
0
MAY 2 7 2004
SECTION II
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K040411
Submitter:
Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538 Telephone: (510)-979-5012 Facsimile: (510) 979-5212
Contact Person:
David Casal, Ph.D. Vice-President, Clinical, Regulatory and Quality Affairs Telephone: (510)-979-5012 Facsimile: (510) 979-5212
Preparation Date:
February 17, 2004
Device Information:
| Device Classification Name: Radioimmunoassay, Oxycodone | |
|---|---|
| Common/Usual Name: | Oxycodone Immunoassay Test System |
| Proprietary Name: | DRI® Oxycodone Assay |
| Regulation Number: | 21 CFR§862.3650 |
| Regulatory Name: | Oxycodone test system |
| Product Code: | DJG |
| Regulatory Class: | Class II |
Predicate Devices:
The DRI® Oxycodone Assay is substantially equivalent to the Rapidone-Oxy Test (K014101) manufactured by American Bio Medica Corp (Columbia, MD) for its general intended use.
1
Device Description:
The DRI® Oxycodone Assay is supplied as liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect oxycodone and oxymonthone without significant cross-reactivity to other opiate compounds. The assay is based on computition between oxycodone labeled with glucose-6-phosphate dehydrogenase (G6PDH), and oxycodone present in the urine sample for a fixed amount of specific antibody binding and a necess. In the absence of free oxycodone in the sample, the specific antibody binds the drug labeled with G6PDH and causes a decrease in enzyme activity. This phenomenon creates a direct relationship between the drug concentration in urine and enzyme activity. The enzyme activity is deternined spectrophotometrically at 340 nm by measuring the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.
Intended Use:
The DRL® Oxycodone Enzyme Immunoassay is intended for the qualitative and semi-quantitative detection of oxycodone 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. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
2
Comparison to Predicate Device(s):
The information provided in this pre-market notification demonstrates that the DRI® Oxycodone Assay is substantially equivalent to the Rapidone-Oxy Test (K014101) manufactured by American Bio Medica Corp (Columbia, MD) for its general intended use.
| Device
| Characteristics | Subject Device | Predicate Device (K014101) |
|---|---|---|
| Intended Use | The DRI®Oxycodone Enzyme | |
| Immunoassay is intended for the | ||
| qualitative and semi-quantitative | ||
| detection of oxycodone in human | ||
| urine. | RapidOne-OXY Test is a one-step, | |
| lateral flow immunoassay for | ||
| detection of oxycodone in urine. | ||
| RapidOne-OXY Test is intended for | ||
| the qualitative detection of oxycodone | ||
| in human urine at 100 ng/mL. | ||
| RapidOne-OXY Test is intended for | ||
| professional use. It is not intended for | ||
| over the counter sales to non- | ||
| professionals. The assay is easy to | ||
| perform, but should not be used | ||
| without proper supervision. This | ||
| immunoassay is a simplified | ||
| qualitative screening method that | ||
| provides only a preliminary result for | ||
| use in determining the need for | ||
| additional confirmatory testing, i.e., | ||
| gas chromatography/mass | ||
| spectrometry (GC/MS). | ||
| 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. | ||
| Clinical and professional judgment | ||
| should be applied to any drug of abuse | ||
| test result, particularly when | ||
| preliminary results are used. | The RapidOne-OXY Test provides | |
| only a preliminary analytical test | ||
| result. A more specific alternative | ||
| chemical method must be used to | ||
| obtain a more 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 results are used. | ||
| Analyte | Oxycodone | Oxycodone |
| Matrix | Urine | Urine |
| Calibrator Form | Liquid | None |
| Calibrator Levels | Five (5) Levels (0, 100, 300, 500 and | |
| 1000 ng/mL) | None | |
| Storage | 2°C to 8°C until expiration date | Room temperature or refrigerated (2 |
| to 8°C). | ||
| Stability | Until expiration date noted on vial | |
| label and Package Insert for Kit and | ||
| reconstituted reagents. | Until expiration date noted on vial | |
| label. |
3
Summary:
The information provided in this pre-market notification demonstrates that the DRI® Oxycodone Assay is substantially equivalent to the Rapidone-Oxy Test (K014101) manufactured by American Bio Medica Corp (Columbia, MD) for its general intended use. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device as confirmed by gas chromatography/mass spectrometry, an independent analytical method. The information supplied in this pre-market notification provides reasonable assurance that the DRT® Oxycodone Assay is safe and effective for its stated intendcd use.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
MAR 1 1 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Microgenics Corporation Thermo Fisher Scientific, Clinical Diagnostic Division c/o Lisa Charter Manager, Regulatory Affairs 46360 Fremont Blvd. Fremont, CA 94538-6406
Re: K040411
Trade/Device Name: DRI Oxycodone Assay DRI Oxycodone Calibrators DRI Oxycodone Controls Regulation Number: 21CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG, DLJ, LAS Dated: February 17, 2004 Received: March 2, 2004
Dear Ms. Charter:
This letter corrects our substantially equivalent letter of May 27, 2004.
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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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.html for the 2DRH'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 tollome number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
CA
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
INDICATIONS FOR USE
510(k) Number (if known): He
Device name: DRI® Oxycodone Assay
Indications for Use:
The DRI® Oxycodone Assay is intended to be used for the qualitative and semiquantitative determination of the presence of oxycodone in human urine at cutoffs of 100 and 300 ng/mL. The assay provides a simple and rapid analytical screening procedure to detect oxycodone 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. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
The DRI® Oxycodone Calibrators are used to calibrate the DRI® Oxycodone Assay in human urine.
The DRI® Oxycodone Controls are used to qualify the DRI® Oxycodone Assay in human urine.
Prescription Use × (Part 21 CFR §801 Subpart D) AND/OR
Over-the Counter Use (21 CFR §807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040411