(40 days)
No
The description details a standard in vitro diagnostic assay based on kinetic interaction of microparticles (KIMS technology) and antibody binding. There is no mention of AI, ML, or any computational methods beyond basic signal processing for absorbance measurement.
No
The device is an in vitro diagnostic test designed to detect substances in human urine, which is used for diagnosis and monitoring, not for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose."
No
The device description clearly states it is an "in vitro diagnostic test" and describes the use of "microparticles in a solution (KIMS technology)" and "light transmission" for measurement. This indicates the device involves physical reagents and hardware components (automated clinical chemistry analyzers) for its function, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states: "Barbiturates Plus is an in vitro diagnostic test..."
- Device Description: The description reiterates that it is an "in vitro diagnostic test".
- Anatomical Site: It analyzes "human urine", which is a biological sample taken from the body, a key characteristic of IVDs.
- Intended User/Care Setting: It is intended for use in "laboratories", which is a typical setting for performing in vitro diagnostic tests.
- Purpose: The test is used for the "qualitative and semi-quantitative detection of barbiturates in human urine" and the results are used in the "diagnosis and treatment of barbiturate use or overdose". This aligns with the purpose of IVDs, which are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
Therefore, based on the provided information, the Barbiturates Plus device clearly fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Barbiturates Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose. Barbiturates Plus provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.
Product codes
DIS
Device Description
The Roche ONLINE DAT Barbiturates Plus assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.
The ONLINE DAT Barbiturates Plus assay is based on the kinetic interaction of microparticles in a solution (KIMS technology). Assay measurement is based on measurable changes in light transmission related to the interaction of microparticles in a solution and the sample drug of interest, if present. Secobarbital drug derivative is conjugated to microparticles in solution, and secobarbital polyclonal antibody (sheep) is solubilized in buffer. In the absence of sample drug, free antibody binds to drug-microparticle conjugates causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases.
When a urine sample contains the drug in question, this drug competes with the particle-bound drug derivative for free antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
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
§ 862.3150 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
DEC 2, 9 2004
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
9115 Hague Rd.
Indianapolis, IN 46250
(317) 521-7637
Contact Person: Kerwin Kaufman
Date Prepared: November 18, 2004 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Device name | Proprietary name: ONLINE DAT Barbiturates Plus
Common name: Barbiturate test system
Classification name: Enzyme immunoassay, Barbiturate |
| 3) Predicate device | We claim substantial equivalence to the currently marketed Abuscreen OnLine Barbiturates assay (K983698). |
Continued on next page
1
510(k) Summary, Continued
The Roche ONLINE DAT Barbiturates Plus assay is an in vitro diagnostic 4) Device Description test for the qualitative and semi-quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.
Principal of procedure
The ONLINE DAT Barbiturates Plus assay is based on the kinetic interaction of microparticles in a solution (KIMS technology). Assay measurement is based on measurable changes in light transmission related to the interaction of microparticles in a solution and the sample drug of interest, if present. Secobarbital drug derivative is conjugated to microparticles in solution, and secobarbital polyclonal antibody (sheep) is solubilized in buffer. In the absence of sample drug, free antibody binds to drug-microparticle conjugates causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases.
When a urine sample contains the drug in question, this drug competes with the particle-bound drug derivative for free antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. 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-conjugated microparticles + free antibody = particle aggregates (↑ absorbance)
Positive Sample
sample drug + drug-conjugated microparticle = particle aggregation inhibited drug-conjugated microparticles + free antibody = particle aggregates
Continued on next page
2
510(k) Summary, Continued
Barbiturates Plus is an in vitro diagnostic test for the qualitative and semi-5.) Intended Use quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. The Roche ONLINE DAT Barbiturates Plus is substantially equivalent to 6.) Comparison to the Predicate other products in commercial distribution intended for similar use. Most Device notably, it is substantially equivalent to the currently marketed Roche Abuscreen OnLine Barbiturates (K983698). Both the new and predicate device assays are based on the kinetic interaction of microparticles in a solution (KIMS technology). Differences between this application and the predicate cleared assay include: . a change in the accelerant / activator contained in the diluent solution used to make the antibody working solution (R1 reagent), and . use of new (previously cleared) calibrators and unassayed controls.
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, with flowing lines representing movement or connection.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 9 2004
Mr. Kerwin Kaufman, MBA, M.T. (ASCP) Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K043211
Trade/Device Name: ONLINE DAT Barbiturates Plus Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS Dated: November 18, 2004 Received: November 19, 2004
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html
Sincerely yours,
petiry
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K043211
Device Name: ONLINE DAT Barbiturates Plus
Indications For Use:
Barbiturates Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose. Barbiturates Plus provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of GDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
5100 K0432//
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