(36 days)
VITEK® 2 Gram Positive Meropenem for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. VITEK 2 Gram Positive Meropenem for Streptococcus pneumoniae is a quantitative test. It is 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.
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 gramnegative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.
The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology. The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.
Here's an analysis of the provided information regarding the acceptance criteria and study for the VITEK® 2 Gram Positive Meropenem for Streptococcus pneumoniae device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for antimicrobial susceptibility testing systems are defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems (Issued Feb. 5, 2003). While the precise numerical targets for "acceptable performance" of Essential Agreement and Category Agreement are not explicitly stated within the provided text, the document indicates that the device met these criteria. However, for a complete understanding, one would typically refer to that FDA guidance document. Based on the provided text, we can infer the reported performance metrics.
| Acceptance Criteria Category | Reported Device Performance | Reference Method |
|---|---|---|
| Overall Essential Agreement | 97.3% | CLSI broth microdilution |
| Overall Category Agreement | 92.9% | CLSI broth microdilution |
| Reproducibility | Acceptable results | Not specified |
| Quality Control | Acceptable results | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The exact number of isolates used in the external evaluation is not explicitly stated. The text mentions "fresh and stock clinical isolates and stock challenge strains."
- Data Provenance: The study was an "external evaluation." The country of origin is not specified, but bioMérieux, Inc. is based in Hazelwood, MO, USA. The isolates included "fresh and stock clinical isolates," indicating a mix of prospective (fresh) and retrospective (stock) clinical data, alongside "stock challenge strains."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the text. The ground truth was established by the CLSI broth microdilution reference method, which is a standardized laboratory procedure, not typically an expert consensus reading.
4. Adjudication Method for the Test Set
This information is not applicable as the ground truth was established by a laboratory reference method (CLSI broth microdilution), not by human expert interpretation that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of an automated device against a reference method, not on human-in-the-loop performance or the effect of AI assistance on human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this was a standalone performance study. The VITEK® 2 system (an automated device/algorithm) was evaluated independently against the CLSI broth microdilution reference method.
7. The Type of Ground Truth Used
The ground truth used was the CLSI broth microdilution reference method. This is a laboratory standard for determining the minimum inhibitory concentration (MIC) of antimicrobials.
8. The Sample Size for the Training Set
The text does not provide information regarding a separate "training set" or its sample size. The description pertains to a validation study (external evaluation) for a device that already exists. Device development often involves internal validation and optimization, but those details are not part of this 510(k) submission summary.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, information on how its ground truth was established is not provided.
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JAN 1 1 2007
510(k) SUMMARY
VITEK® 2 Gram Positive Meropenem for Streptococcus pneumoniae
B : D M &
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum RoadHazelwood, MO 63042 |
| Contact Person: | Jolyn TenlladoSenior Regulatory Affairs Specialist |
| Phone Number: | 314 -731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | December 4, 2006 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Meropenem for Streptococcuspneumoniae |
| Classification Name: | Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility Device, 21 CFR 866.1645 |
| Common Name: | VITEK 2 AST-GP Meropenem for Streptococcuspneumoniae |
| Predicate Device: | VITEK 2 Gram Positive Telithromycin for Streptococcuspneumoniae (K053186). |
D. 510(k) Summarv:
B.
C.
VITEK® 2 Gram Positive Meropenem for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. It is 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. The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.
VITEK 2 Gram Positive Meropenem for Streptococcus pneumoniae demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as
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defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued Feb. 5, 2003.
The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Meropenem for Streptococcus pneumoniae. An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Positive Meropenem for Streptococcus pneumoniae by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), K050002. VITEK 2 Gram Positive Amoxicillin for Streptococcus pneumoniae demonstrated acceptable performance of 97.3% overall Essential Agreement and 92.9% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jolyn Tenllado Senior Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
IJAN 1 1 2007
Re: K063623 Trade/Device Name: VITEK® 2 Gram Positive Meropenem for Streptococcus pneumoniae (<0.06 - ≥ 4 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: December 4, 2006 Received: December 6, 2006
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 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)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely vours.
Sally, autry
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
510(k) Number (if known): K O 63 26 3
Device Name: VITEK® 2 Gram Positive Meropenem for Streptococcus pneumoniae (< 0.06 - > 4 µg/ml)
Indications For Use:
VITEK® 2 Gram Positive Meropenem for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. VITEK 2 Gram Positive Meropenem for Streptococcus pneumoniae is a quantitative test. It is 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.
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 gramnegative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.
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)
Freddie Poole
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Sa
K06 3263
§ 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.”