(67 days)
Benzodiazepines Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers at cutoff concentrations of 100 ng/ml, 200 ng/ml and 300 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 Benzodiazepines Plus assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers at cutoff concentrations of 100 ng/ml, 200 ng/ml and 300 ng/ml. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. The 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. Benzodiazepine drug derivative is conjugated to microparticles in solution, and benzodiazepine 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.
The provided text describes a 510(k) summary for the Roche ONLINE DAT Benzodiazepines Plus assay, an in vitro diagnostic test for detecting benzodiazepines in human urine. However, it does not contain the detailed study information, acceptance criteria, or performance data that would allow for a complete answer to your request.
Specifically, the document focuses on regulatory approval and equivalence to a predicate device, rather than a detailed performance study with explicit acceptance criteria and corresponding results.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
What can be gathered from the provided text:
- Device Name: ONLINE DAT Benzodiazepines Plus
- Intended Use: Qualitative and semi-quantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers at cutoff concentrations of 100 ng/ml, 200 ng/ml, and 300 ng/ml. Semi-quantitative results allow assessment of assay performance as part of a quality control program.
- Predicate Device: Abuscreen OnLine Benzodiazepines assay (K983702).
- Technology: Kinetic interaction of microparticles in a solution (KIMS technology).
- Differences from Predicate (Improvements):
- Change in accelerant/activator in the diluent solution for the antibody working solution.
- Change in polyclonal antibody purification (from non-specific IgG binding to immunoaffinity purification).
- Improved precision.
- Use of new (previously cleared) calibrators and unassayed controls.
- Regulatory Status: Substantially equivalent to the predicate device, allowing it to be marketed.
Missing Information (and why it's missing from this document):
The 510(k) summary provided is a high-level overview for regulatory filing. It emphasizes substantial equivalence to a previously cleared device. A full study report, which would typically contain the detailed performance data, acceptance criteria, sample sizes, and ground truth methodologies, is not included in this summary. Such details would be found in the manufacturer's internal validation studies, not necessarily in the public-facing 510(k) summary.
In conclusion, while the document explains the device's purpose and its regulatory pathway, it does not offer the specific data points required to fill out the table and answer the detailed questions about acceptance criteria and study particulars.
{0}------------------------------------------------
510(k) Summary
K 043327
| 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: December 1, 2004 | |
| 2) Device name | Proprietary name: ONLINE DAT Benzodiazepines Plus Common name: Benzodiazepines test system Classification name: Enzyme immunoassay, Benzodiazepines |
| 3) Predicate device | We claim substantial equivalence to the currently marketed Abuscreen OnLine Benzodiazepines assay (K983702). |
Continued on next page
{1}------------------------------------------------
The Roche ONLINE DAT Benzodiazepines Plus assay is an in vitro 4) Device Description diagnostic test for the qualitative and semi-quantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers at cutoff concentrations of 100 ng/ml, 200 ng/ml and 300 ng/ml. Semiquantitative 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 Benzodiazepines 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. Benzodiazepine drug derivative is conjugated to microparticles in solution, and benzodiazepine polyclonal antibody (sheep) is solubilized in In the absence of sample drug, free antibody binds to drugbuffer. 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
Benzodiazepines Plus is an in vitro diagnostic test for the qualitative and 5.) Intended semi-quantitative detection of benzodiazepines in human urine on automated Use clinical chemistry analyzers at cutoff concentrations of 100 ng/ml, 200 ng/ml and 300 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 Benzodiazepine Plus assay 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 Abuscreen OnLine Benzodiazepines (K983702).
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),
- a change in polyclonal antibody purification from non-specific . IgG binding to immunoaffinity purification,
- improved precision, 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and body.
FEB - 7 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kerwin Kaufman, MBA, MT (ASCP) Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457
K043327 Re:
Trade/Device Name: ONLINE DAT Benzodiazepines Plus Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: Class II Product Code: JXM Dated: December 1, 2004 Received: December 2, 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).
{4}------------------------------------------------
Page 2 -
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,
Jean McCogger, MS, DUM
Jean M. Cooper, MS. D.V.M. 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): K043327
ONLINE DAT Benzodiazepines Plus Device Name:
Indications For Use:
Benzodiazepines Plus is an in vitro diagnostic test for the qualitative and semi-Buantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers at cutoff concentrations of 100 ng/ml, 200 ng/ml and 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.
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 CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
acting
Office of In Vitro Diagnostic
510(k) K043321
Page 1 of
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).