(99 days)
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.
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.
The provided text describes the DRI® Oxycodone Assay, its intended use, and its comparison to a predicate device for substantial equivalence. However, it does not contain a formal study, acceptance criteria, or performance data in the structured format requested. The document is primarily a 510(k) summary, which outlines the device's characteristics and its proposed equivalence to a legally marketed predicate device, rather than a detailed report of internal validation studies with explicit acceptance criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets and training sets, data provenance, or details on ground truth establishment for these sets.
- Information on experts, adjudication methods, or MRMC studies.
Here's what can be extracted based on the provided text, outlining why the requested information is absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. The document focuses on demonstrating "substantial equivalence" to a predicate device rather than defining specific performance thresholds for the new device and then proving it meets them.
- Reported Device Performance: Performance metrics such as sensitivity, specificity, accuracy, or other diagnostic performance indicators are not provided in this 510(k) summary. The comparison focuses on device characteristics (intended use, analyte, matrix, calibrator form/levels, storage, stability) to show similarity with the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified.
- Retrospective or Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable as no specific test set or expert-established ground truth is described.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable as no specific test set or ground truth adjudication process is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not mentioned. This device is an immunoassay for drug detection, not an imaging device typically evaluated with MRMC studies or human reader performance.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: The device is described as a "homogeneous enzyme immunoassay" and its performance is evaluated in comparison to a predicate device and confirmed by Gas Chromatography/Mass Spectrometry (GC/MS). The document implies a "standalone" analytical performance being assessed, but specific metrics like accuracy against GC/MS are not quantified in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For establishing substantial equivalence and confirming performance, the document states, "...as confirmed by gas chromatography/mass spectrometry, an independent analytical method." Therefore, Gas Chromatography / Mass Spectrometry (GC/MS) is explicitly identified as the preferred confirmatory method and the basis for comparison.
8. The sample size for the training set
- Sample Size for Training Set: Not specified. This document relates to a 510(k) submission, not a study design detail for model training.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: As no training set is described, the method for establishing its ground truth is not provided.
In summary: The provided text is a 510(k) summary for a diagnostic device. Its purpose is to demonstrate substantial equivalence to a predicate device, as confirmed by an independent analytical method (GC/MS). It does not contain a detailed report of a study with explicit acceptance criteria, performance metrics, or specifics about test and training datasets typically found in a clinical or algorithm validation study report.
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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.
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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.
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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.
| DeviceCharacteristics | Subject Device | Predicate Device (K014101) |
|---|---|---|
| Intended Use | The DRI®Oxycodone EnzymeImmunoassay is intended for thequalitative and semi-quantitativedetection of oxycodone in humanurine. | RapidOne-OXY Test is a one-step,lateral flow immunoassay fordetection of oxycodone in urine. |
| RapidOne-OXY Test is intended forthe qualitative detection of oxycodonein human urine at 100 ng/mL. | ||
| RapidOne-OXY Test is intended forprofessional use. It is not intended forover the counter sales to non-professionals. The assay is easy toperform, but should not be usedwithout proper supervision. Thisimmunoassay is a simplifiedqualitative screening method thatprovides only a preliminary result foruse in determining the need foradditional confirmatory testing, i.e.,gas chromatography/massspectrometry (GC/MS). | ||
| The assay provides only a preliminaryanalytical test result. A more specificalternative chemical method must beused to obtain a confirmed analyticalresult. Gas chromatography /massspectrometry (GC/MS) is thepreferred confirmatory method.Clinical and professional judgmentshould be applied to any drug of abusetest result, particularly whenpreliminary results are used. | The RapidOne-OXY Test providesonly a preliminary analytical testresult. A more specific alternativechemical method must be used toobtain a more confirmed analyticalresult. Gas chromatography /massspectrometry (GC/MS) is thepreferred confirmatory method.Clinical and professional judgmentshould be applied to any drug of abusetest result, particularly whenpreliminary results are used. | |
| Analyte | Oxycodone | Oxycodone |
| Matrix | Urine | Urine |
| Calibrator Form | Liquid | None |
| Calibrator Levels | Five (5) Levels (0, 100, 300, 500 and1000 ng/mL) | None |
| Storage | 2°C to 8°C until expiration date | Room temperature or refrigerated (2to 8°C). |
| Stability | Until expiration date noted on viallabel and Package Insert for Kit andreconstituted reagents. | Until expiration date noted on viallabel. |
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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.
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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.
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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
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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
§ 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.