(88 days)
The cassette COBAS INTEGRA Opiates contains an in vitro diagnostic reagent test system intended for use on the COBAS INTEGRA 700 for the semiquantitative and qualitative detection of morphine and its metabolites at cutoff concentrations of 300 and 2000 ng/mL in human urine.
The cassette COBAS INTEGRA Opiates contains an in vitro diagnostic reagent test system intended for use on the COBAS INTEGRA 700 for the semiquantitative and qualitative detection of morphine and its metabolites at cutoff concentrations of 300 and 2000 ng/mL in human urine. The cassette COBAS INTEGRA Opiates is based on the kinetic interaction of microparticles in a solutions (KIMS) as a measured by changes in light transmission. In the absence of sample drug, soluble drug-polymer conjugate binds to antibody bound microparticle, causing the formation of particle aggregates. When a urine sample containing the dug in question is present, this drug competes with the drug conjugate 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 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
The provided text for K992890 describes the device, its intended use, and its similarities to a predicate device, but does not include a detailed study proving the device meets acceptance criteria. The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full performance study with acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in the provided document.
Here's a breakdown of what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided 510(k) summary. The summary states: "The Roche COBAS INTEGRA Opiates 300/2000 and the predicate device use the same reagents, and have similar performance characteristics." This implies that performance was assessed for substantial equivalence, but specific acceptance criteria and detailed performance metrics are not listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not available in the provided 510(k) summary.
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):
This information is not available in the provided 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not available in the provided 510(k) summary.
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:
This is not applicable. The device described is an in vitro diagnostic reagent test system for the detection of opiates in urine, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a reagent test system for an automated analyzer (COBAS INTEGRA 700). Its performance is inherently "standalone" in the sense that it provides a result based on the chemical reaction, without human interpretation of raw data in the same way an imaging algorithm would. However, the details of its standalone performance study (beyond the claim of "similar performance characteristics" to the predicate) are not available in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not available in the provided 510(k) summary. For an in vitro diagnostic device, ground truth for performance evaluation typically involves reference methods like GC/MS (Gas Chromatography/Mass Spectrometry) for confirmatory testing, but this is not specified here.
8. The sample size for the training set:
This information is not available in the provided 510(k) summary. As it's a reagent-based immunoassay, the concept of a "training set" in the context of machine learning algorithms is not directly applicable in the same way. Development would involve reagent optimization and calibration, but not an algorithmic training set in the typical sense.
9. How the ground truth for the training set was established:
This information is not available in the provided 510(k) summary. See point 8 regarding the applicability of "training set" for this type of device.
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NOV 2 3 1999
510(k) Summary
[
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| 1) Submitter name, address, contact | Roche Diagnostics Corporation9115 Hague RdIndianapolis, IN 46250(317) 845-3362Contact person: Lisa M. GerardDate prepared August 26, 1999 |
|---|---|
| 2) Device name | Proprietary name: Roche COBAS INTEGRA OpiatesCommon name: Opiates test systemClassification name: Enzymatic Immunoassay, Opiate |
| 3) Predicate device | We claim substantial equivalence to the currently marketed Roche Abuscreen OnLine II for Opiates (K974840). |
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510(k) Summary, Continued
The cassette COBAS INTEGRA Opiates contains an in vitro diagnostic 4) Device description reagent test system intended for use on the COBAS INTEGRA 700 for the semiquantitative and qualitative detection of morphine and its metabolites at cutoff concentrations of 300 and 2000 ng/mL in human urine. The cassette COBAS INTEGRA Opiates is based on the kinetic interaction of microparticles in a solutions (KIMS) as a measured by changes in light transmission. In the absence of sample drug, soluble drug-polymer conjugate binds to antibody bound microparticle, causing the formation of particle aggregates. When a urine sample containing the dug in question is present, this drug competes with the drug conjugate 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 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
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510(k) Summary, Continued
The cassette COBAS INTEGRA Opiates contains an in vitro diagnostic 5) Intended use reagent test system intended for use on the COBAS INTEGRA 700 for the semiquantitative and qualitative detection of morphine and its metabolites at cutoff concentrations of 300 and 2000 ng/mL in human urine. The Roche COBAS INTEGRA Opiates 300/2000 and the predicate device 6) Comparison to the predicate use the same reagents, and have similar performance characteristics. Modifications to the Roche COBAS INTEGRA Opiates 300/2000 include the device, similarities addition of: a 300 ng/mL semiquantitative cutoff and .
- an application for the Integra family of analyzers. .
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 2 3 1999
Ms. Lisa M. Gerard Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
Re: K992890
Trade Name: COBAS INTEGRA Opiates 300/2000 Regulatory Class: II Product Code: DJG Dated: November 8, 1999 Received: November 9, 1999
Dear Ms. Gerard:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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.
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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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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Indications for Use Statement
| 510(k) Number (if known): | K992890 |
|---|---|
| Device Name: | Roche COBAS INTEGRA Opiates |
| Indications for Use: | The cassette COBAS INTEGRA Opiates contains an in vitro diagnostic reagent test system intended for use on the COBAS INTEGRA 700 for the semiquantitative and qualitative detection of morphine and its metabolites at cutoff concentrations of 300 and 2000 ng/mL in human urine. |
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ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use ✓ (Per 21 CFR 801.109) | OR | Over-the-Counter Use ______ |
|---|---|---|
| ----------------------------------------------------------------------------------------- | ---- | ----------------------------- |
(Optional format 1-2-96)
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992890
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§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).