(77 days)
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No
The description focuses on traditional broth dilution susceptibility testing and visual reading, with no mention of AI or ML technologies.
No
The device is used to determine antimicrobial susceptibility and detect ESBL production, which are diagnostic purposes, not therapeutic.
Yes
The device is designed for "determination of antimicrobial agent susceptibility" and "detection of ESBL production" in specific bacteria, which are diagnostic purposes to guide treatment decisions.
No
The device description clearly states it is a miniaturization of a broth dilution susceptibility test, involving physical panels, rehydration with water, incubation, and visual observation. This indicates a hardware component (the panel) is central 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 "determination of antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in Escherichia coli, Klebsiella oxytoca and Klebsiella pneumoniae." This is a classic example of an in vitro diagnostic test, as it's performed on biological samples (bacterial colonies) outside of the body to provide information about a patient's condition (susceptibility to antibiotics and presence of ESBLs).
- Device Description: The description details a "miniaturizations of the broth dilution susceptibility test" which is a laboratory method used to determine the effectiveness of antimicrobial agents against microorganisms. This process is performed in a laboratory setting using biological samples.
- Performance Studies: The performance studies describe testing with "ESBL producing strains" and comparing results to "molecular characterization data," further indicating its use in diagnosing or characterizing a biological condition.
The device is designed to be used in a laboratory setting to analyze biological samples (bacterial colonies) to provide information relevant to patient diagnosis and treatment decisions (which antibiotics will be effective). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MicroScan® ESBL plus ESBL Confurmation Panel is designed for use in the determination of antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in Escherichia coli, Klebsiella oxytoca and Klebsiella pneumoniae. After inoculation, panels are incubated for a minimum of 16 hours at 35°C in a non-CO2 incubator, and read visually, according to the Package Insert.
This particular submission is for the addition of the antimicrobials Ceftazidime (0.5-128 ug/ml), Cefotaxime (0.5-128 ug/ml), Ceftazidime/Clavulanic Acid (0.12/4-32/4 ug/ml) and Cefotaxime/Clavulanic Acid (0.12/4-32/4 µg/ml) to the test panel.
The Gram-Negative organisms which may be used for detection of ESBL production in this panel are:
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Product codes
JWY
Device Description
The MicroScan® ESBL plus ESBL Confirmation Panel is designed for use in the determination of antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in Escherichia coli, Klebsiella oxytoca and Klebsiella pneumoniae.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobials agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water, after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator at 35 °C for a minimum of 16 hours, the minimum inhibitory concentration (MIC) for the test organism is determined by observing the lowest antimicrobial concentration showing inhibition of growth.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Efficacy and Challenge testing with MicroScan® Dried Gram Negative panel with Ceftazidime, Ceftazidime/Clavulanic Acid, Ceftriaxone and Ceftriaxone/Clavulanic Acid was conducted with both ESBL Collainens Claraducing strains including AmpC and HiK 1 type strains. The Efficacy and Challenge studies were designed to confirm the acceptability of these antimicrobial agents for confirmation of ESBLs (E. coli, K. oveoca, and K. pneumoniae) by comparing the panel susceptibility results against previously generated molecular characterization data. The Dried panel antimicrobial agents demonstrated an overall Agreement of > 90% with the ESBL and non-ESBL producing strains.
Inoculum reproducibility testing with the MicroScan® Dried Gram Negative panel with Ceftazidime, mobilime/Clavulanic Acid, Ceftriaxone and Ceftriaxone/Clavulanic Acid demonstrated acceptable reproducibility regardless of which inoculum method (i.e., Turbidity and Prompt) was used.
The MicroScan® Dried Gram Negative panel with Ceftazidime/Clavulanic Acid, Ceftriaxone I ho Mitroovar "Directorial cid antimicrobial agents demonstrated acceptable Quality Control throughout each phase of the ESBL evaluation.
Key Metrics
Agreement of > 90% with the ESBL and non-ESBL producing strains.
Acceptable reproducibility
Acceptable Quality Control
Predicate Device(s)
MicroScan Dried Gram-Negative MIC/Combo Panels
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
0
MAR 2 2 2002
K 020037
510(k) Submission Information:
| Device Manufacturer: | Dade MicroScan Inc. |
|---|---|
| Contact name: | Cynthia Van Duker, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | January 2, 2002 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram Negative MIC/Combo Panels with |
| Ceftazidime, Cefotaxime, Ceftazidime/Clavulanic Acid and | |
| Cefotaxime/Clavulanic Acid | |
| 510(k) Notification: | New antimicrobials - Ceftazidime/Clavulanic Acid and Ceftriaxone/Clavulanic Acic |
| New Intended Use – Ceftazidime and Ceftriaxone | |
| Predicate device: | MicroScan Dried Gram-Negative MIC/Combo Panels |
510(k) Summary:
The MicroScan® ESBL plus ESBL Confirmation Panel is designed for use in the determination of antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in Escherichia coli, Klebsiella oxytoca and Klebsiella pneumoniae.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobials agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water, after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator at 35 °C for a minimum of 16 hours, the minimum inhibitory concentration (MIC) for the test organism is determined by observing the lowest antimicrobial concentration showing inhibition of growth.
Ceftazidime and Ceftriaxone have been cleared for susceptibility testing via Premarket Notification Submissions . This Premarket Notification (510[k]) presents data in support of a request for a new intended use (confirmation of suspected E. coli, K. oxytoca, and K. pneumoniae extended spectrum beta-lactamases) similar to that described in the NCCLS document M100-S9 for Ceftazidime, and Ceftriaxone alone and in combination with Clavulanic Acid.
Efficacy and Challenge testing with MicroScan® Dried Gram Negative panel with Ceftazidime, Ceftazidime/Clavulanic Acid, Ceftriaxone and Ceftriaxone/Clavulanic Acid was conducted with both ESBL Collainens Claraducing strains including AmpC and HiK 1 type strains. The Efficacy and Challenge studies were designed to confirm the acceptability of these antimicrobial agents for confirmation of ESBLs (E. coli, K. oveoca, and K. pneumoniae) by comparing the panel susceptibility results against previously generated molecular characterization data. The Dried panel antimicrobial agents demonstrated an overall Agreement of > 90% with the ESBL and non-ESBL producing strains.
Inoculum reproducibility testing with the MicroScan® Dried Gram Negative panel with Ceftazidime, mobilime/Clavulanic Acid, Ceftriaxone and Ceftriaxone/Clavulanic Acid demonstrated acceptable reproducibility regardless of which inoculum method (i.e., Turbidity and Prompt) was used.
The MicroScan® Dried Gram Negative panel with Ceftazidime/Clavulanic Acid, Ceftriaxone I ho Mitroovar "Directorial cid antimicrobial agents demonstrated acceptable Quality Control throughout each phase of the ESBL evaluation.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 2 2002
Ms. Cynthia Van Duker Regulatory Affairs Manager Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
K020037 Re:
Trade/Device Name: MicroScan® Dried Gram-Negative MIC/Combo Panels with Ceftazidime, (0.5-128 µg/ml), Cefotaxime (0.5-128 µg/ml), Ceftazidime/Clavulanic Acid (0.12/4-32/4 µg/ml), and Cefotaxime/Clavulanic Acid (0.12/4-32/4 µg/ml)
Regulation Number: 21 CFR 866.1640
Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: January 2, 2002 Received: January 4, 2002
Dear Ms. Van Duker:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o no re ro review a your worked the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce arior 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 fray of the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
Page 1 of 1 .
510(k) Number (if known): K ク2 ಲಂ 37
MicroScan® Dried Gram-Negative MIC/Combo Panels with Ceftazidime (0.5-128 Device Name: ug/ml), Cefotaxime (0.5-128 µg/ml), Ceftazidime/Clavulanic Acid (0.12/4-32/4 ug/ml) and Cefotaxime/Clavulanic Acid (0.12/4-32/4 ug/ml)
Indications For Use:
The MicroScan® ESBL plus ESBL Confurmation Panel is designed for use in the determination of antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing gram negative bacilli and for the detection of ESBL production in Escherichia coli, Klebsiella oxytoca and Klebsiella pneumoniae. After inoculation, panels are incubated for a minimum of 16 hours at 35°C in a non-CO2 incubator, and read visually, according to the Package Insert.
This particular submission is for the addition of the antimicrobials Ceftazidime (0.5-128 ug/ml), Cefotaxime (0.5-128 ug/ml), Ceftazidime/Clavulanic Acid (0.12/4-32/4 ug/ml) and Cefotaxime/Clavulanic Acid (0.12/4-32/4 µg/ml) to the test panel.
The Gram-Negative organisms which may be used for detection of ESBL production in this panel are:
Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Fredde M. Poole
(Division Sign-Off) (Division of Clinical Laboratory Devices
510(k) Number K020037
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use - - - -
(Optional Format 1-2-96)
OR