(209 days)
MicroScan® MICroSTREP plus® Panels
No
The document describes a standard broth dilution susceptibility test read visually or by an instrument, with no mention of AI/ML in the device description, intended use, or performance studies.
No.
This device is an in-vitro diagnostic (IVD) device used to determine the antimicrobial susceptibility of microorganisms, not to treat a condition or disease in a patient.
Yes
The device is used to "determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media", which provides information for the diagnosis and treatment of infections.
No
The device description clearly outlines a physical panel with dehydrated antimicrobial agents that are rehydrated and incubated. While it can be read visually or with an instrument (which may involve software), the core device is a physical panel, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the panel is used to determine the "quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (bacterial colonies) outside of the body to provide information about a patient's condition (susceptibility to antibiotics).
- Device Description: The description details how the panel works by performing miniaturized broth dilution susceptibility tests. This process involves rehydrating dehydrated antimicrobial agents with a broth and a standardized suspension of the organism, followed by incubation and reading the minimum inhibitory concentration (MIC). This entire process is performed in vitro (in a lab setting).
- Performance Studies: The "Summary of Performance Studies" describes comparing the device's performance to a "CLSI frozen Reference Panel." This comparison is done to demonstrate the device's accuracy in determining antimicrobial susceptibility, which is a key characteristic of an IVD.
The device is designed to be used in a laboratory setting to analyze biological samples and provide diagnostic information about the susceptibility of bacteria to antimicrobial agents, which directly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To determine antimicrobial agent susceptibility.
The MicroScan® MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 – 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan® WalkAway instrument.
This particular submission is for the evaluation of antimicrobial agent penicillin on the MicroScan® MICroSTREP plus® Panel utilizing the updated Streptococcus pneumoniae meningitis interpretative criteria (S ≤ 0.06, R ≥ 0.12) and non-meningitis interpretative criteria (S ≤ 2, I = 4, R ≥ 8).
The organisms which may be used for Penicillin susceptibility testing in this panel are:
Streptococcus pneumoniae
Streptococci (Groups A, C, G, H, L and M)
Streptococcus agalactiae
Viridans Streptococci
Product codes (comma separated list FDA assigned to the subject device)
LTT, LRG
Device Description
MicroScan MICroSTREP plus® Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic streptococci including Streptococcus pneumoniae. After inoculation, panels are incubated for 20-24 hours at 35°C +/-1°C in a non-CO2 incubator, and read visually or with the MicroScan WalkAway instrument according to the Package Insert.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in water, buffer, or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This Special 510(k) presents data and information in support of updating the penicillin labeling for the updated Streptococcus pneumoniae interpretive criteria (meningitis S ≤ 0.06, R ≥ 0.12 and nonmeningitis S ≤ 2, I = 4, R > 8).
The Streptococcus pneumoniae data from the previously cleared Penicillin external evaluations (K062773 and K020626) were compared to the performance of a CLSI frozen Reference panel utilizing the revised interpretative criteria (meningitis S ≤ 0.06, R ≥ 0.12 and non-meningitis S ≤ 2, I = 4, R > 8). Challenge strains were compared to Expected Results determined prior to the evaluations. The MICroSTREP plus® Panel demonstrated acceptable performance versus the with an overall Essential Agreement of 92.5% for Penicillin when compared with the frozen Reference panel.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 92.5% for Penicillin
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.
MicroScan® MICroSTREP plus® Panels
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
§ 866.1640 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).
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K09/949
JAN 2 6 2010
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510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Siemens Healthcare Diagnostics |
|---|---|
| Contact name: | Shannon Popson, Regulatory Affairs Senior Technical Specialist |
| Fax: | 916-374-3330 |
| Date prepared: | June 16, 2009 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® MICroSTREP plus® Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | Device Modification – Evaluation of Penicillin (K062773) versus |
| Streptococcus pneumoniae interpretive criteria (meningitis S ≤ 0.06, R ≥ 0.12 and non-meningitis S ≤ 2, I = 4, R ≥ 8). | |
| Predicate device: | MicroScan® MICroSTREP plus® Panels |
510(k) Summary:
MicroScan MICroSTREP plus® Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic streptococci including Streptococcus pneumoniae. After inoculation, panels are incubated for 20-24 hours at 35°C +/-1°C in a non-CO2 incubator, and read visually or with the MicroScan WalkAway instrument according to the Package Insert.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in water, buffer, or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.
The proposed MicroScan MICroSTREP plus® Panel demonstrated substantially equivalent performance when compared with an CLSI frozen Reference Panel, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated March 5, 2007.
This Special 510(k) presents data and information in support of updating the penicillin labeling for the updated Streptococcus pneumoniae interpretive criteria (meningitis S ≤ 0.06, R ≥ 0.12 and nonmeningitis S ≤ 2, I = 4, R ≥ 8).
The Streptococcus pneumoniae data from the previously cleared Penicillin external evaluations (K062773 and K020626) were compared to the performance of a CLSI frozen Reference panel utilizing the revised interpretative criteria (meningitis S ≤ 0.06, R ≥ 0.12 and non-meningitis S ≤ 2, I = 4, R > 8). Challenge strains were compared to Expected Results determined prior to the evaluations. The MICroSTREP plus® Panel demonstrated acceptable performance versus the with an overall Essential Agreement of 92.5% for Penicillin when compared with the frozen Reference panel.
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread. The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenuc Building 66 Silver Spring, MD 20993
JAN 2 6 2010
Shannon Popson Senior Technical Specialist, Regulatory Affairs Siemens Healthcare Diagnostics, Inc. 2040 Enterprise Blvd. West Sacramento, CA 95691
Re: K091949
Trade/Device Name: MicroScan® MICroSTREP plus® Panel Regulation Number: 21 CFR 1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: LTT, LRG Dated: January 14, 2010 Received: January 19, 2010
Dear Ms. Popson:
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
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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 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/cdrl/industry/support/index.html.
Sincerely vours.
Jolgatpus
Sally A. Hojvat, Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indication for Use
510(k) Number (if known):
Device Name: MicroScan® MICroSTREP plus® Panels with Penicillin (0.015 - 16 ug/ml)
Indication For Use:
The MicroScan® MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 – 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan® WalkAway instrument.
This particular submission is for the evaluation of antimicrobial agent penicillin on the MicroScan® MICroSTREP plus® Panel utilizing the updated Streptococcus pneumoniae meningitis interpretative criteria (S ≤ 0.06, R ≥ 0.12) and non-meningitis interpretative criteria (S ≤ 2, I = 4, R ≥ 8).
The organisms which may be used for Penicillin susceptibility testing in this panel are:
Streptococcus pneumoniae Streptococci (Groups A, C, G, H, L and M) Streptococcus agalactiae Viridans Streptococci
Prescription Use ブ (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
fey oot
Division Sign-Of Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091949
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