(73 days)
Not Found
No
The device description details a fluorescence polarization immunoassay and a nonlinear least squares regression analysis for curve fitting, which are standard analytical techniques and do not indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is an in vitro diagnostic reagent system used to quantify amikacin in human serum or plasma to monitor drug concentrations, not to provide therapy.
Yes
The device is described as an "in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the quantitative determination of amikacin in human serum or heparinized plasma." This clearly states its purpose as a diagnostic tool for measuring amikacin levels in patient samples.
No
The device description clearly outlines a reagent system and its use on a physical analyzer (COBAS INTEGRA 700) that performs fluorescence polarization measurements and calculations. This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagent system is "intended for use on the COBAS INTEGRA analyzer for the quantitative determination of amikacin in human serum or heparinized plasma." This is a classic definition of an in vitro diagnostic test, as it's used to analyze a sample taken from the human body (serum or plasma) outside of the body ("in vitro") to provide information about a medical condition or state (the concentration of amikacin).
- Device Description: The "Device Description" further reinforces this by describing a "reagent system intended for use on the COBAS INTEGRA 700 analyzer for the quantitative determination of amikacin in human serum or heparinized plasma." It details the analytical principle (fluorescence polarization) used to measure the substance in the sample.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K954992) and the name "Roche COBAS INTEGRA Amikacin" strongly suggests that this device is being compared to a previously cleared IVD device, which is a common regulatory pathway for IVDs.
The information provided clearly indicates that this device is designed to perform a test on human biological samples outside of the body to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The cassette COBAS INTEGRA Amikacin MAB contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the quantitative determination of amikacin in human serum or heparinized plasma.
Product codes
LGJ
Device Description
The Roche COBAS INTEGRA Amikacin MAB assay contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA 700 analyzer for the quantitative determination of amikacin in human serum or heparinized plasma.
The COBAS INTEGRA Amikacin MAB assay determinations are made on the COBAS INTEGRA 700 analyzer using the principle of fluorescence polarization. When a fluorescent molecule, or fluorophore, is irradiated with light of the proper wavelength (the excitation wavelength) some of the light is absorbed. Within a few nano-seconds the absorbed light is emitted, although at a longer wavelength (the emission wavelength). Whether or not the emitted light is polarized depends on the freedom of the fluorophore to rotate in solution. A small molecule, such as fluorescein, can rotate rapidly before light emission occurs, resulting in depolarization of the emitted light. In contrast, a fluorescent macromolecule, such as a fluorescein-labeled protein, will rotate much more slowly. Thus, in the time frame between excitation and emission, the macromolecule will have rotated only very slightly and the emitted light will be polarized.
Fluorescence polarization is a reproducible function of the drug concentration, and is suitable for the quantitative determination of drug concentrations in serum for the purpose of therapeutic drug monitoring.
Surface active agents are used to ensure dissociation of the drug from serum proteins and to prevent nonspecific binding of the tracer.
After completion of the assay, the COBAS INTEGRA 700 will calculate automatically the millipolarization units (mP) of the tracer. After mP values have been calculated for the 6 calibrators, the system calculates a best-fit curve for the calibrators using a nonlinear lest squares regression analysis. The concentration of drug in each sample is then interpolated from this curve using its measured mP value.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3035 Amikacin test system.
(a)
Identification. An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.(b)
Classification. Class II.
0
JUL 222 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 May 7, 1999 | |
| 2) Device name | Proprietary name: COBAS INTEGRA Amikacin MAB |
| Common name: Enzymatic assay for the determination of Amikacin | |
| Classification name: Amikacin test system | |
| 3) Predicate device | We claim substantial equivalence to the Roche COBAS INTEGRA Amikacin (K954992). |
Continued on next page
1
510(k) Summary, Continued
- Device description The Roche COBAS INTEGRA Amikacin MAB assay contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA 700 analyzer for the quantitative determination of amikacin in human serum or heparinized plasma.
The COBAS INTEGRA Amikacin MAB assay determinations are made on the COBAS INTEGRA 700 analyzer using the principle of fluorescence polarization. When a fluorescent molecule, or fluorophore, is irradiated with light of the proper wavelength (the excitation wavelength) some of the light is absorbed. Within a few nano-seconds the absorbed light is emitted, although at a longer wavelength (the emission wavelength). Whether or not the emitted light is polarized depends on the freedom of the fluorophore to rotate in solution. A small molecule, such as fluorescein, can rotate rapidly before light emission occurs, resulting in depolarization of the emitted light. In contrast, a fluorescent macromolecule, such as a fluorescein-labeled protein, will rotate much more slowly. Thus, in the time frame between excitation and emission, the macromolecule will have rotated only very slightly and the emitted light will be polarized.
Fluorescence polarization is a reproducible function of the drug concentration, and is suitable for the quantitative determination of drug concentrations in serum for the purpose of therapeutic drug monitoring.
Surface active agents are used to ensure dissociation of the drug from serum proteins and to prevent nonspecific binding of the tracer.
After completion of the assay, the COBAS INTEGRA 700 will calculate automatically the millipolarization units (mP) of the tracer. After mP values have been calculated for the 6 calibrators, the system calculates a best-fit curve for the calibrators using a nonlinear lest squares regression analysis. The concentration of drug in each sample is then interpolated from this curve using its measured mP value.
Continued on next page
2
510(k) Summary, Continued
The cassette COBAS INTEGRA Amikacin MAB contains and in vitro 5) Intended use diagnostic reagent system intended for use on the COBAS INTEGRA 700 analyzer for the quantitative determination of amikacin in human serum or heparinized plasma. The Roche COBAS INTEGRA Amikacin MAB (AMIKM) is substantially 6) Comparison to the predicate equivalent to other products in commercial distribution intended for similar device use. Most notably, it is substantially equivalent to the currently marketed Roche COBAS INTEGRA Amikacin (AMIK)(K954992). The Roche COBAS INTEGRA Amikacin MAB assay contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA 700 analyzer for the quantitative determination of amikacin in human serum or heparinized plasma. Modifications of the Roche COBAS INTEGRA Amikacin MAB assay include: changing rabbit polyclonal antibody with mouse monoclonal antibody . and . changing the assay parameters. The modification has resulted in improved: . analytical sensitivity and . specificity.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
JUL 22 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lisa M. Gerard Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
Re: K991597
Trade Name: Roche COBAS INTEGRA Amikacin Regulatory Class: II Product Code: LGJ Dated: May 7, 1999 Received: May 10, 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 (OS) 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 Sutman
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): | K991597 |
|---|---|
| Device Name: | COBAS INTEGRA Amikacin MAB |
| Indications for | |
| Use: | The cassette COBAS INTEGRA Amikacin MAB contains and in vitro |
| diagnostic reagent system intended for use on the COBAS INTEGRA | |
| analyzer for the quantitative determination of amikacin in human serum or | |
| heparinized plasma. | |
| (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON | |
| ANOTHER PAGE IF NEEDED) |
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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
| | Prescription Use V_
OR
Over-the-Counter Use _
(Per 21 CFR 801.109) |
| | (Optional format 1-2-96) |
| | |
| | |
| | (Division Sign-Off)
Division of Clinical Laboratory Devices |
510(k) Number_K 991 597
. . . . .
: