(105 days)
VITEK® 2 Streptococcus Penicillin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus Penicillin is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Penicillin has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial.
Active In Vitro and in Clinical Infections against:
Beta hemolytic streptococci groups C and G Streptococcus pyogenes Streptococcus agalactiae Streptococcus viridans group Streptococcus pneumoniae
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.
VITEK® 2 Streptococcus Penicillin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus Penicillin is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
This document appears to be a 510(k) summary for a medical device called VITEK® 2 Streptococcus Penicillin. It describes the device's intended use and provides general regulatory information, but it does not contain detailed information about acceptance criteria, the specific study design, or its results that would allow me to populate all the requested fields.
The document states in Section D. 510(k) Summary that "Penicillin has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial." This implies that the device's performance is being compared to some existing standard or expectation, but the actual acceptance criteria and the data proving it are not present in this summary.
Therefore, I can only fill in what is explicitly mentioned or can be inferred from the provided text.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied/Standard) | Reported Device Performance |
|---|---|
| Penicillin active against listed microorganisms (as per FDA label for penicillin) | VITEK® 2 Streptococcus Penicillin is designed for antimicrobial susceptibility testing of Streptococcus species and determines in vitro susceptibility to penicillin for the specified microorganisms. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not mentioned in this summary.
- Data Provenance: Not mentioned in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not mentioned in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not mentioned in this summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is an Antimicrobial Susceptibility Test System, not an imaging device typically involving "human readers" in the way an AI diagnostic tool would. Therefore, an MRMC study with "human readers" improving with AI assistance is not applicable to this device type. The device provides automated susceptibility testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is described as an "automated quantitative or qualitative susceptibility testing" system. This implies a standalone (algorithm only) performance for determining susceptibility. However, the details of such a study are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For antimicrobial susceptibility tests, the ground truth typically involves standard reference methods (e.g., broth microdilution or agar dilution as described by CLSI – Clinical and Laboratory Standards Institute) to determine the Minimum Inhibitory Concentration (MIC) of an antimicrobial agent against a microorganism. While not explicitly stated, this is the standard practice for such devices.
8. The sample size for the training set:
- Not mentioned in this summary. This document is a 510(k) summary, not a detailed study report.
9. How the ground truth for the training set was established:
- Not mentioned in this summary. (See point 7 for likely method).
{0}------------------------------------------------
K1/2000
OCT 2 6 2011
Image /page/0/Picture/2 description: The image shows the logo for bioMérieux. The logo consists of the word "BIOMÉRIEUX" in all caps, with a stylized image above it. The image is a circle split in half, with one half filled with vertical lines and the other half solid black, and a curved line going through the center of the circle and the text.
510(k) SUMMARY
VITEK® 2 AST-ST Penicillin
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum RoadHazelwood, MO 63042 |
| Contact Person: | Jolyn TenlladoDirector, Regulatory Affairs |
| Phone Number: | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | July 12th, 2011 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 Streptococcus Penicillin |
| Classification Name: | 21 CFR 866.1645Antimicrobial Susceptibility TestProduct Code LON |
| Common Name: | VITEK® 2 AST-ST Penicillin |
| C. Predicate Device: | VITEK® 2 AST-GP Amoxicillin for S. pneumoniae (K063597) |
D. 510(k) Summary:
VITEK® 2 Streptococcus Penicilin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus Penicillin is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Penicillin has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial.
Active In Vitro and in Clinical Infections against:
Beta hemolytic streptococci groups C and G Streptococcus pyogenes Streptococcus agalactiae Streptococcus viridans group Streptococcus pneumoniae
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacili, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.
bioMérieux, Inc. 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700 http://www.biomerieux-usa.com Page 256
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and evenly spaced around the circle.
10903 New Hampshire Avenue Silver Spring, MD 20993
OCT 2 6 2011
bioMérieux, Inc. c/o Jolyn Tenllado Director, Regulatory Affairs 595 Anglum Road Hazelwood, Missouri 63042-2320
Re: K112000
Trade/Device Name: VITEK® 2 Streptococcus Penicillin (≤ 0.06 - ≥ 8 ug/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: short-term Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: LON Dated: October 19, 2011 Received: October 20, 2011
Dear Ms. Tenllado:
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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket
{2}------------------------------------------------
Page 2 - Jolyn Tenllado
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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally A. Torgon
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
{3}------------------------------------------------
Indications for Use
510(k) Number (if known):_KI | 2000
Device Name: VITEK® 2 Streptococcus Penicillin (≤ 0.06 - ≥ 8 ug/mL)
Indications For Use:
VITEK® 2 Streptococcus Penicillin is designed for antimicrobial susceptibility testing of Streptococcus species. VITEK® 2 Streptococcus Penicillin is a quantitative test intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Penicillin has been shown to be active against most strains of the microorganism listed below, according to the FDA label for this antimicrobial.
Active In Vitro and in Clinical Infections against:
Beta hemolytic streptococci groups C and G Streptococcus pyogenes Streptococcus agalactiae Streptococcus viridans group Streptococcus pneumoniae
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 System for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
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)
Freddie Lee Poole
Division Sign Off
Avision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K11 9800
Page 1 of 1
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”