(57 days)
Not Found
No
The device description details a fluorescence polarization immunoassay, a standard laboratory technique, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic reagent system used to detect substances (barbiturates) in bodily fluids, which means it aids in diagnosis rather than actively treating an ailment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic reagent system." It also mentions its use for "detection of barbiturates and their metabolites in human serum, heparinized plasma or urine" for "toxicological screenings where the analytical result is used in the management of barbiturate use or overdose," which are characteristics of a diagnostic device.
No
The device description clearly outlines a reagent system and its use with a physical analyzer (COBAS INTEGRA), indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states, "The cassette COBAS Integra Serum Barbiturates contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of barbiturates and their metabolites in human serum, heparinized plasma or urine." This directly identifies it as an in vitro diagnostic reagent system.
- Device Description: The description reiterates that it is an "in vitro diagnostic reagent for use on the COBAS INTEGRA systems for the detection of barbiturates and their metabolites in plasma, serum or urine."
- Function: The device analyzes biological samples (serum, plasma, urine) outside of the body to detect the presence of specific substances (barbiturates and their metabolites). This is the core function of an in vitro diagnostic device.
- Purpose: The intended use is for "toxicological screenings where the analytical result is used in the management of barbiturate use or overdose." This indicates the results are used for medical purposes, which is characteristic of IVDs.
Therefore, based on the provided text, the device is clearly an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The cassette COBAS Integra Serum Barbiturates contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of barbiturates and their metabolites in human serum, heparinized plasma or urine. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of barbiturate use or overdose.
Product codes
DIS
Device Description
The COBAS INTEGRA Serum Barbiturates assay is an in vitro diagnostic reagent for use on the COBAS INTEGRA systems for the detection of barbiturates and their metabolites in plasma, serum or urine. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of barbiturate use or overdose. The COBAS INTEGRA Serum Barbiturates assay is based on fluorescence polarization (FP) methodology. Fluorescence polarization measures the change in angle of polarized light emitted by a fluorescent molecule. This change in polarization is dependent on molecule rotation, which is dependent on molecule size. FP utilizes a homogeneous competitive binding immunoassay with particle-bound fluorescein-labeled drug derivative to detect barbiturates and their metabolites in unknown samples. In the absence of sample drug, free antibody (R1) binds to fluorescein-labeled drug derivative (R3), causing the fluorescein-labeled drug derivative to rotate slowly. The large complex rotates more slowly than the free fluoresceinlabeled drug derivative in solution, thereby causing the light emitted to remain highly polarized. When a urine sample contains the drug in question, this drug competes with the fluorescein-labeled drug derivative for antibody. The small fluoresceinlabeled drug derivative molecules will rotate rapidly in solution and the emitted light will be depolarized. The large molecules (antibody bound to fluorescein labeled drug) will rotate slowly and the light emitted will remain highly polarized. Large molecules = slow rotation = polarized light retained = high polarization Small molecules = rapid rotation = depolarized light = low polarization Unknown sample drug content is determined relative to the value obtained from samples of known drug content, which have been used to establish a standard curve. The presence of drug decreases polarization in proportion to the concentration of drug in the sample.
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)
The assay performance characteristics for urine and serum samples are extremely similar.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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
JUN 2 2 1999
૪૧૧૫૫૫૫
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 April 23, 1999 |
| 2) Device name | Proprietary name: Roche COBAS INTEGRA Serum Barbiturates |
| | Common name: Homogeneous fluorescence immunoassay for the determination of barbiturates in plasma, serum and urine |
| | Classification name: Enzyme Immunoassay, Barbiturates test system |
| 3) Predicate device | We claim substantial equivalence to the Roche COBAS INTEGRA Serum Barbiturates (K982551). |
Continued on next page
26
1
510(k) Summary, Continued
The COBAS INTEGRA Serum Barbiturates assay is an in vitro diagnostic 4) Device reagent for use on the COBAS INTEGRA systems for the detection of description barbiturates and their metabolites in plasma, serum or urine. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of barbiturate use or overdose. The COBAS INTEGRA Serum Barbiturates assay is based on fluorescence polarization (FP) methodology. Fluorescence polarization measures the change in angle of polarized light emitted by a fluorescent molecule. This change in polarization is dependent on molecule rotation, which is dependent on molecule size. FP utilizes a homogeneous competitive binding immunoassay with particle-bound fluorescein-labeled drug derivative to detect barbiturates and their metabolites in unknown samples. In the absence of sample drug, free antibody (R1) binds to fluorescein-labeled drug derivative (R3), causing the fluorescein-labeled drug derivative to rotate slowly. The large complex rotates more slowly than the free fluoresceinlabeled drug derivative in solution, thereby causing the light emitted to remain highly polarized. When a urine sample contains the drug in question, this drug competes with the fluorescein-labeled drug derivative for antibody. The small fluoresceinlabeled drug derivative molecules will rotate rapidly in solution and the emitted light will be depolarized. The large molecules (antibody bound to fluorescein labeled drug) will rotate slowly and the light emitted will remain highly polarized. Large molecules = slow rotation = polarized light retained = high polarization Small molecules = rapid rotation = depolarized light = low polarization Unknown sample drug content is determined relative to the value obtained from samples of known drug content, which have been used to establish a standard curve. The presence of drug decreases polarization in proportion to the concentration of drug in the sample.
Continued on next page
2
510(k) Summary, Continued
The cassette COBAS INTEGA Serum Barbiturates contains an in vitro 5) Intended use diagnostic reagent intended for use on the COBAS INTEGRA analyzer for the detection of barbiturates and their metabolites in human serum, heparinized plasma or urine.
The Roche COBAS INTEGRA Serum Barbiturates and the predicate device 6) Comparison use the same reagents, on the same analyzer. The Roche COBAS INTEGRA to the predicate device, Serum Barbiturates assay has been modified to include parameters for urine similarities samples. The assay performance characteristics for urine and serum samples are extremely similar.
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in black.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 2 1999
Ms. Lisa M. Gerard Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, Indiana 46250-0457
Re: K991440
Trade Name: Roche COBAS INTEGRA Serum Barbiturates (SBARB) Regulatory Class: II Product Code: DIS Dated: April 23, 1999 Received: April 26, 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.
4
Page 2
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/cdrh/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): | K991440 |
|---|---|
| Device Name: | Roche COBAS INTEGRA Serum Barbiturates |
| Indications for Use: | The cassette COBAS Integra Serum Barbiturates contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of barbiturates and their metabolites in human serum, heparinized plasma or urine. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of barbiturate use or overdose. |
(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) | Dan Cooper (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | ||
| 510(k) Number K991440 |