(88 days)
Not Found
No
The description details a chemical assay based on kinetic interaction of microparticles and light transmission, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in vitro diagnostic reagent test system for detecting substances in human urine, not for treating a condition or disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic reagent test system." This clearly indicates its purpose is for diagnosis.
No
The device description clearly indicates it is a reagent test system based on the kinetic interaction of microparticles in solutions, which is a chemical and physical process, not a software-only function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The cassette COBAS INTEGRA Opiates contains an in vitro diagnostic reagent test system..."
- Nature of the Test: The device is designed to detect substances (morphine and its metabolites) in a biological sample (human urine) outside of the body. This is the fundamental definition of an in vitro diagnostic test.
- Purpose: The purpose is for the "semiquantitative and qualitative detection" of these substances, which is a diagnostic activity.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DJG
Device Description
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
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)
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
§ 862.3650 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).
0
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 Corporation
9115 Hague Rd
Indianapolis, IN 46250
(317) 845-3362
Contact person: Lisa M. Gerard
Date prepared August 26, 1999 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name | Proprietary name: Roche COBAS INTEGRA Opiates
Common name: Opiates test system
Classification name: Enzymatic Immunoassay, Opiate |
| 3) Predicate device | We claim substantial equivalence to the currently marketed Roche Abuscreen OnLine II for Opiates (K974840). |
Continued on next page
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1
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
Continued on next page
2
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. .
3
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
5
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. |
(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 ______ |
|---|---|---|
| ----------------------------------------------------------------------------------------- | ---- | ----------------------------- |
(Optional format 1-2-96)
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992890
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