(33 days)
Other BBL TM Sensi-Disc TM (eg, Ciprofloxacin 5 µg, BBL TM Sensi-Disc TM )
Not Found
No
The device is a physical disk impregnated with an antimicrobial agent used in a standardized agar diffusion test. The description focuses on the physical properties of the disk and the established, non-AI/ML based testing methodology. There is no mention of any computational analysis or algorithms.
No
The device is an antimicrobial susceptibility test disk used for in vitro testing, not for treating patients.
Yes
The device is described as an "Antimicrobial Susceptibility Test Disk" which is used for "semi-quantitative in vitro susceptibility testing". This indicates that the device is used to determine the susceptibility of bacteria to an antimicrobial agent, which is a diagnostic function in determining appropriate treatment.
No
The device description clearly states it is a physical disk made of impregnated paper, which is a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the device is used for "semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures." The term "in vitro" is a key indicator of an IVD. It also describes the purpose of the test: "determining the susceptibility to telithromycin of a wide range of bacteria." This is a diagnostic purpose, helping to determine the appropriate treatment for a patient based on the bacteria's susceptibility to the antibiotic.
- Device Description: The description details how the device is used in a laboratory setting ("agar diffusion test method") to analyze a biological sample (bacteria).
- Regulatory Context: The document mentions FDA approval and adherence to standards from organizations like the FDA, WHO, and CLSI, which are relevant to the regulation of IVDs.
Therefore, based on the provided information, the Telithromycin 15ug BBL™ Sensi-Disc™ is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Antimicrobial Susceptibility Test Disks are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Telithromycin 15ug BBL™ is intended for use in determining the susceptibility to telithromycin of a wide range of bacteria, as described in the "Indications for Use" section. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer and received FDA approval under NDA Number 21-144.
Use of Telithromycin 15ug, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to telithromycin. The concentration of 15ug has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA approved drug insert for this antimicrobic.
Active In Vitro and in clinical infections against:
Aerobic gram-positive microorganisms Staphylococcus aureus (methicillin and erythromycin susceptible isolates only)
Streptococcus pneumoniae (including multi-drug resistant isolates)
Aerobic gram-negative microorganisms
Haemophilus influenzae
Active In Vitro Against:
Aerobic gram-positive microorganisms Streptococcus pyogenes (erythromycin susceptible isolates only Streptococci (Lancefield groups C and G) Viridans group streptococci
Product codes (comma separated list FDA assigned to the subject device)
JTN
Device Description
Telithromycin 15ug BBL™ Sensi-Disc™ is prepared by impregnating high quality paper with accurately determined amounts of Telithromycin supplied by the drug manufacturer. Each Telithromycin disk is clearly marked on both sides with the agent and drug content. Telithromycin cartridges each contain 50 impregnated disks that are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Telithromycin disks are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.
Agar diffusion susceptibility methods employing dried filter paper disks impregnated with specific concentrations of antimicrobial agents were developed in the 1940s. In order to eliminate or minimize variability in the testing, Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium.
Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the Clinical and Laboratory Standards Institute (CLSI) [Formerly National Committee for Clinical Laboratory Standards (NCCLS)] and is periodically updated.
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.
Other BBL TM Sensi-Disc TM (eg, Ciprofloxacin 5 µg, BBL TM Sensi-Disc TM )
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
§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
0
510(k) Submission
Telithromycin 15pg BBLTM Sensi-Disc™
NOV 1 4 2005
510(k) SUMMARY
| SUBMITTED BY: | Becton Dickinson and Company 7 Loveton Circle Sparks, MD 21152 Phone 410-316-4905 Fax: 410-316-4499 |
|---|---|
| CONTACT NAME: | Dainelle N. Clark, Regulatory Affairs Specialist |
| DATE PREPARED: | November 08, 2005 |
| DEVICE TRADE NAME: | Telithromycin 15µg, BBL TM Sensi-Disc TM Antimicrobial Susceptibility Test Disks |
| DEVICE COMMON NAME: | Antimicrobial Susceptibility Test Disks |
| DEVICE CLASSIFICATION: | 21 CFR§866.1620, Class II (Product Code JTN), Susceptibility Test Disks, Antimicrobial |
| PREDICATE DEVICE: | Other BBL TM Sensi-Disc TM (eg, Ciprofloxacin 5 µg, BBL TM Sensi-Disc TM ) |
INTENDED USE:
Antimicrobial Susceptibility Test Disks are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Telithromycin 15ug BBL™ is intended for use in determining the susceptibility to telithromycin of a wide range of bacteria, as described in the "Indications for Use" section. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer and received FDA approval under NDA Number 21-144.
1
510(k) SUMMARY
Indications for Use:
Use of Telithromycin 15ug, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to telithromycin. The concentration of 15ug has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA approved drug insert for this antimicrobic.
Active In Vitro and in clinical infections against:
Aerobic gram-positive microorganisms Staphylococcus aureus (methicillin and erythromycin susceptible isolates only)
Streptococcus pneumoniae (including multi-drug resistant isolates)
Aerobic gram-negative microorganisms
Haemophilus influenzae
Active In Vitro Against:
Aerobic gram-positive microorganisms Streptococcus pyogenes (erythromycin susceptible isolates only Streptococci (Lancefield groups C and G) Viridans group streptococci
2
DEVICE DESCRIPTION:
Telithromycin 15ug BBL™ Sensi-Disc™ is prepared by impregnating high quality paper with accurately determined amounts of Telithromycin supplied by the drug manufacturer. Each Telithromycin disk is clearly marked on both sides with the agent and drug content. Telithromycin cartridges each contain 50 impregnated disks that are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Telithromycin disks are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.
Agar diffusion susceptibility methods employing dried filter paper disks impregnated with specific concentrations of antimicrobial agents were developed in the 1940s. In order to eliminate or minimize variability in the testing, Bauer et al. developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium.
Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the Clinical and Laboratory Standards Institute (CLSI) [Formerly National Committee for Clinical Laboratory Standards (NCCLS)] and is periodically updated.
DEVICE PRINCIPLE:
Disks containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates [or Haemophilus Test Medium Agar for Haemophilus influenzae or Mueller Hinton Agar with 5% Sheep Blood for Streptococcus species] inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the disks are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The categorical interpretation [susceptible (S), intermediate (I), or resistant (R)] for the organism being tested with the antimicrobial agent is made by comparing zone diameters to those found in the respective organism tables of CLSI/NCCLS Document M2 ("Performance Standards for Antimicrobial Disk Susceptibility Tests) and of CLSI/NCCLS Document M100 ("Performance Standards for Antimicrobial Susceptibility Testing").
3
DEVICE COMPARISON:
The BBLTM Sensi-Disc™ Antimicrobial Susceptibility Test Disks - Telithromycin 15ug is similar to the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 ug in that:
- Both methods are for antimicrobial susceptibility testing using paper disks impregnated with . an antimicrobial agent.
- . Both methods have the same intended use.
- . Both methods provide the user with antimicrobic minimum inhibitory concentration (MIC) results based on measurements of zone diameters.
- . Both methods require the user to determine categorical interpretations (S/I/R) using the measured zone diameters against CLSI/NCCLS Approved Standards M2 and M100.
- . Both methods use pure cultures of bacterial isolates.
The BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks - Telithromycin 15µg differs from the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg in that:
- BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks Telithromycin 15ug is a . susceptibility test that uses disks impregnated with the antimicrobic Telithromycin at a concentration of 15ug while the BBLTM Sensi-Disc™ Antimicrobial Susceptibility Test Disks - Ciprofloxacin 5 µg is a susceptibility test that uses disks impregnated with the antimicrobic Ciprofloxacin at a concentration of 5 ug.
- . BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disk - Telithromycin 15 ug is a susceptibility test used to test a different battery of microorganisms than the BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disk - Ciprofloxacin 5 ug.
SUBSTANTIAL EQUIVALENCE TESTING DATA:
See the Telithromycin drug package insert, "Susceptibility Tests: Diffusion Techniques" (Appendix 1).
4
Image /page/4/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 an abstract symbol that resembles a stylized human figure with three horizontal lines above it, possibly representing the concept of health and well-being.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 4 2005
Ms. Dainelle N. Clark Regulatory Affairs Specialist BD Diagnostics Systems Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152
K052876 Re:
Trade/Device Name: BBL™ Sensi-Disc ™ Antimicrobial Susceptibility Test Disks, Telithromycin 15 ug Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial Susceptibility Test Disc Regulatory Class: Class II
Product Code: JTN Dated: October 11, 2005 Received: October 12, 2005
Dear Ms. Clark:
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).
5
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,
Sale, a Hopp
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K052876 510(k) Number (if known):
Device Name: BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disks, Telithromycin 15ug
Indications for Use:
Use of Telithromycin 15μg, BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to telithromycin. The concentration of 15μg has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA approved drug insert for this antimicrobic.
Active In Vitro and in clinical infections against:
Aerobic gram-positive microorganisms Staphylococcus aureus (methicillin and erythromycin susceptible isolates only) Streptococcus pneumoniae (including multi-drug resistant isolates)
Aerobic gram-negative microorganisms Haemophilus influenzae
Active In Vitro Against:
Aerobic gram-positive microorganisms Streptococcus pyogenes (erythromycin susceptible isolates only Streptococci (Lancefield groups C and G) Viridians group streptococci
Prescription Use V (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR 801 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)
Freddie th. Poole
Division Sign Off
Division Sign-Off
)ffice of In Vitro Diagnostic Device Evaluation and Safety
Becton, Dickinson and Company
510(k)