(40 days)
No
The description focuses on automated microdilution techniques and growth monitoring, with no mention of AI or ML.
No
This device is for in vitro diagnostic (IVD) use, specifically for determining the antimicrobial susceptibility of bacteria. It is a laboratory aid and does not directly treat or diagnose patients.
Yes
The device aids in the determination of in vitro susceptibility to antimicrobial agents, providing an MIC value and interpretive category result, which are used to inform patient treatment decisions by identifying effective antibiotics for infections.
No
The device description clearly outlines physical components like "VITEK 2 AST Cards," a "VITEK 2 System," and a "VITEK 2 Compact," which are hardware. The process involves rehydrating antimicrobial medium within the card and the system automatically filling, sealing, and incubating the card. This indicates a significant hardware component is integral to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "in vitro susceptibility testing" and is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This clearly indicates testing is performed outside of the body using biological samples.
- Device Description: The description details how the device uses bacterial isolates (biological samples) and antimicrobial medium within a card to determine susceptibility. This process is performed in a laboratory setting.
- Performance Studies: The performance studies compare the device's performance with a "CLSI (NCCLS) microbroth dilution reference method," which is a standard in vitro diagnostic technique.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 viren = and virier = oompact lonies for the most clinically significant aerobic gramsusceptiblicy toculing of hocaccus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.
VITEK® 2 Gram Positive Ertapenem 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.
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
VITEK® 2 Gram Positive Ertapenem 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.
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
laboratory aid
Description of the training set, sample size, data source, and annotation protocol
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 Ertapenem for Streptococcus pneumoniae by comparing its performance with the CLSI (NCCLS) microbroth dilution reference method.
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)
An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains. VITEK 2 Gram Positive Ertapenem for Streptocccus pneumoniae demonstrated substantially equivalent performance when compared with the CLSI (NCCLS) reference agar dilution method, as 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 data is representative of performance on both the VITEK 2 System 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 Ertapenem for Streptococcus pneumoniae demonstrated acceptable performance of 94.9% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
94.9% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
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.
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.
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
§ 866.1645 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.”
0
BIOMÉRIEUX
510(k) SUMMARY
AUG 1 6 2005
VITEK® 2 Gram Positive Ertapenem for Streptococcus pneumoniae
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. | |
|---|---|---|
| Address: | 595 Anglum Road | |
| Hazelwood, MO 63042 | ||
| Contact Person: | Nancy Weaver | |
| Staff Regulatory Affairs Specialist | ||
| Phone Number: | 314 -731-8695 | |
| Fax Number: | 314-731-8689 | |
| Date of Preparation: | July 6, 2005 | |
| B. Device Name: | ||
| Formal/Trade Name: | VITEK® 2 Gram Positive Ertapenem for Streptococcus | |
| pneumoniae | ||
| Classification Name: | Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility Device, 21 CFR 866.1645 | ||
| Common Name: | VITEK 2 AST-GP ETP | |
| C. Predicate Device: | VITEK 2 Gram Positive Moxifloxacin for Streptococcus | |
| pneumoniae (K031865). |
D. 510(k) Summary:
B.
VITEK® 2 Gram Positive Ertapenem 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 Ertapenem for Streptocccus pneumoniae demonstrated substantially equivalent performance when compared with the CLSI (NCCLS) reference agar dilution method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued Feb. 5, 2003.
bioMérieux, Inc.
595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700
1
The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Ertapenem 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 Ertapenem for Streptococcus pneumoniae by comparing its performance with the CLSI (NCCLS) microbroth dilution reference method. The data is representative of performance on both the VITEK 2 System 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 Ertapenem for Streptococcus pneumoniae demonstrated acceptable performance of 94.9% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
2
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AUG 1 6 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nancy Weaver Staff Regulatory Affairs Specialist bioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
K051849 Re: Trade/Device Name: VITEK 20 Gram Positive Ertapenem for Streptococcus pneumoniae (≤0.5 - ≥8 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: July 6, 2005 Received: July 7, 2005
Dear Ms. Weaver:
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 (OS) 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,
Sale, a For
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
4
510(k) Number (if known): K051849
Device Name: VITEK® 2 Gram Positive Ertapenem for Streptococcus pneumoniae ( 8 µg/ml)
Indications For Use:
. .
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 viren = and virier = oompact lonies for the most clinically significant aerobic gramsusceptiblicy toculing of hocaccus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.
O: phounder. vilier 2 Gram . Streptococcus pneumoniae. VITEK 2 Gram anniniorobial odoopilland use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
Prescription Use _ X (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
Office of In Vitro Diagnostic Device Evaluation and Safety
p. 10
KO 51849 510(k) _______________________________________________________________________________________________________________________________________________________________________