(68 days)
The cassette COBAS INTEGRA Methadone II contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of methadone in human urine at a cutoff concentration of 300 ng/ml. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.
The cassette COBAS INTEGRA Methadone II contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of methadone in human urine at a cutoff concentration of 300 ng/ml.
Principal of procedure: The COBAS INTEGRA ONLINE DAT II Methadone II assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission. In the absence of sample drug, soluble drugpolymer conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates. When a urine sample containing the drug in question is present, this drug competes with the conjugate-bound drug derivative for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. Conversely, the presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.
This document is a 510(k) summary for the Roche Diagnostics COBAS INTEGRA ONLINE DAT II Methadone II, an in vitro diagnostic reagent system for the detection of methadone in human urine. It establishes substantial equivalence by comparing it to a previously cleared predicate device, the Roche COBAS INTEGRA Methadone assay (K951595). The summary describes the device's intended use and the principle of its operation (Kinetic Interaction of Microparticles in Solution - KIMS).
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not include explicit acceptance criteria in terms of numerical thresholds (e.g., sensitivity, specificity, accuracy percentages) or a table of reported device performance against such criteria. The document focuses on establishing substantial equivalence to a predicate device and describes the assay's principle.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for a test set or the data provenance (e.g., country of origin, retrospective or prospective) for any performance evaluation.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The provided text does not mention the number of experts used to establish ground truth or their qualifications. For an in vitro diagnostic device like this, ground truth would typically be established through confirmatory analytical methods, not expert human interpretation.
4. Adjudication Method
The provided text does not mention any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is relevant for devices involving human interpretation of results (e.g., radiology images). This device is an automated in vitro diagnostic assay for detecting methadone in urine. Therefore, an MRMC comparative effectiveness study would not be applicable or performed for this type of device. There is no mention of such a study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is an in vitro diagnostic assay, meaning it operates in a standalone manner to produce a result. The entire description of its operation (KIMS principle) is a description of its standalone performance. However, the document does not present a dedicated "standalone performance study" section with specific metrics, but rather implicitly asserts its standalone capability through the description of its mechanism and intended use. The focus is on its performance in comparison to a predicate device for substantial equivalence.
7. Type of Ground Truth Used
For a methadone detection assay, the ground truth would typically be established by confirmatory analytical methods such as Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS). The provided text does not explicitly state how the ground truth was established, but given the nature of the device, it would be laboratory-based analytical confirmation.
8. Sample Size for the Training Set
The provided text does not specify the sample size for a training set. This type of in vitro diagnostic assay might be developed and optimized through iterative testing and calibration, but the concept of a "training set" as understood in machine learning (which often requires explicit specification) is not typically detailed in 510(k) summaries for such devices.
9. How the Ground Truth for the Training Set was Established
Similar to point 8, the provided text does not describe how ground truth for a training set was established.
Summary of what is available in the provided text:
- Acceptance Criteria & Performance: Not explicitly stated or tabulated.
- Test Set Sample Size & Provenance: Not provided.
- Expert Ground Truth & Qualifications: Not applicable/not provided.
- Adjudication Method: Not applicable/not provided.
- MRMC Study: Not applicable/not performed.
- Standalone Performance: Implicitly described by the device's operational principle, but no separate study details are provided.
- Type of Ground Truth: Implied to be confirmatory analytical methods, but not explicitly stated.
- Training Set Sample Size: Not provided.
- Training Set Ground Truth Establishment: Not provided.
The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (Roche COBAS INTEGRA Methadone assay, K951595) by detailing the device's description, intended use, and principal of procedure, and highlighting modifications from the predicate. It does not provide detailed performance study data against specific acceptance criteria.
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510(k) Summary According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. 1) Submitter Roche Diagnostics Corporation name, address, 9115 Hague Rd. contact Indianapolis, IN 46250-0457 (317) 521-7637 Contact Person: Kerwin Kaufman Date Prepared: May 8, 2002 Proprietary name: COBAS INTEGRA ONLINE DAT II Methadone II 2) Device name Common name: Methadone Test System Classification name: Enzyme immunoassay, methadone We claim substantial equivalence to the currently marketed Roche COBAS 3) Predicate device INTEGRA Methadone assay (K951595). のお気になっています。 この時間のお店は、 2007年には、 2007年には、 2007年には、 2005年には、 2008年の 2007年に、 2007年( 2008年) 2007年( 2008年) 2007年( 2008年) 2007年( 2008年) 2007年( 2008年) 2007年( 2008年) 2007年( 2008年) 2
JUL 1 6 2002
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510(k) Summary, Continued
The cassette COBAS INTEGRA Methadone II contains an in vitro diagnostic 4) Device Description reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of methadone in human urine at a cutoff concentration of 300 ng/ml.
Principal of procedure
The COBAS INTEGRA ONLINE DAT II Methadone II assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission. In the absence of sample drug, soluble drugpolymer conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates.
When a urine sample containing the drug in question is present, this drug competes with the conjugate-bound drug derivative for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited.
As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. Conversely, the presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.
Negative Sample
drug-polymer conjugate + antibody-bound microparticle = particle aggregates (1 absorbance)
Positive Sample
sample drug + antibody-bound microparticle = particle aggregation inhibited drug-polymer conjugate + antibody bound microparticle = particle aggregates
Continued on next page
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510(k) Summary, Continued
| 5.) IntendedUse | The cassette COBAS INTEGRA Methadone II contains an in vitro diagnosticreagent system intended for use on COBAS INTEGRA systems for the semi-quantitative and qualitative detection of methadone in human urine at a cutoffof 300 ng/ml. |
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| 6.) Comparisonto the PredicateDevice | The Roche COBAS INTEGRA ONLINE DAT II Methadone II assay issubstantially equivalent to other products in commercial distribution intendedfor similar use. Most notably, it is substantially equivalent to the currentlymarketed Roche COBAS INTEGRA Methadone (K951595).The Roche COBAS INTEGRA ONLINE DAT II Methadone II assay utilizesa modified KIMS technology relative to the currently marketed COBASINTEGRA Methadone assay. Differences between this application and thecleared assay include:use of a methadone monoclonal antibody attached tomicroparticles in solution, a soluble drug-polymer conjugate, and use of new calibrators and unassayed controls. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 2098 Gaither Road JE - JE - JE - JE - JE - JE - JE - JE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Rockville MD 20850
JUL 1 6 2002
Mr. Kerwin Kaufman Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K021512
Trade/Device Name: Roche Diagnostics COBAS INTEGRA DAT II Methadone II Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR Dated: May 8, 2002 Received: May 9, 2002
Dear Mr. Kaufman:
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 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.
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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
Page 2 Station and Parties and portugues and port and more and mind the first and
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
無意識を見てきる。しているのは、との出来ました。
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ppen.ndications.for.Use Statement.com/w/index.php?title=에게이트&oldid=
| 510(k) Number (if known): | K021512 |
|---|---|
| Device Name: | Roche Diagnostics COBAS INTEGRA ONLINE DAT II Methadone II |
| Indications for Use: | The cassette COBAS INTEGRA Methadone II contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA systems for the semiquantitative and qualitative detection of methadone in human urine at a cutoff concentration of 300 ng/ml. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | OR Over-the-Counter Use |
|---|---|
| --------------------------------------- | ------------------------- |
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021512
(Optional format 1-2-96)
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§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).