(50 days)
No
The document describes a traditional broth dilution susceptibility test panel and an automated reading system (WalkAway System), neither of which are described as using AI or ML. The performance studies compare the panel to a reference method, not an AI/ML model.
No
Explanation: The device is an in-vitro diagnostic (IVD) tool used to determine the susceptibility of bacteria to antimicrobial agents, aiding in treatment decisions rather than directly treating a condition.
Yes.
The device is used to determine the susceptibility of specific bacteria to antimicrobial agents, which is a form of diagnostic testing to guide treatment.
No
The device is a physical panel containing dehydrated antimicrobial agents, which is rehydrated and incubated. While it can be read by a system that likely includes software (MicroScan WalkAway System), the core device being submitted is a physical consumable panel.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci including Streptococcus pneumoniae." This is a diagnostic test performed in vitro (outside the body) on biological samples (bacterial colonies).
- Device Description: The description details a "miniaturization of the broth dilution susceptibility test," which is a standard laboratory method for determining the susceptibility of bacteria to antibiotics. This process involves testing the bacteria with different concentrations of antimicrobial agents in a laboratory setting.
- Performance Studies: The performance studies compare the device's performance to a "CLSI frozen Reference panel," which is a standard reference method used in clinical microbiology laboratories for AST. This further confirms its use in a diagnostic context.
- Predicate Device: The predicate device listed (K020556; MicroScan MICroSTREP plus Panels - Levofloxacin) is also an AST system, which are classified as IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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 visually. Alternatively, the panels can be incubated in and read by the MicroScan® WalkAway System, according to the Package insert. This particular submission is for the addition of the antimicrobial agent Linezolid, at concentrations of 0.12 to 16 ug/mL, to the test panel. The organisms which may be used for Linezolid susceptibility testing in this panel are: Streptococcus pneumoniae including multi-drug resistant strains Streptococcus pyogenes Streptococcus agalactiae Viridans group streptococci
Product codes
LRG, JWY, LTW, JTZ
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 . aerobic streptococci, including Streptococcus pneumoniae. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water 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 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB), after inoculation of the broth with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Alternatively, the panel can be incubated in and read by the MicroScan® WalkAway System.
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
The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed MICroSTREP plus Panel by comparing its performance with a CLSI frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 August 28, 2009. The Premarket Notification (510[k]) presents data in support of the MicroScan MICroSTREP plus Panel with Linezolid. The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed MICroSTREP plus Panel by comparing its performance with a CLSI frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The MICroSTREP plus Panel demonstrated acceptable performance with an overall Essential Agreement of 97.2% for Linezolid when compared with the frozen Reference panel. Reproducibility testing demonstrated acceptable reproducibility and precision with Linezolid, regardless of which read method (manual and WalkAway" instrument) was used with the turbidity inoculation method. Quality Control testing demonstrated acceptable results for Linezolid.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 97.2%
Predicate Device(s)
MicroScan MICroSTREP plus Panels - Levofloxacin (K020556)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
February 26, 2021
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Healthcare Diagnostics, Inc. Jenifer Dawson Driscoll Regulatory Technical Specialist % Elisabeth Warriner Senior Analyst, Regulatory Affairs 1584 Enterprise Blvd. West Sacramento, California 95691
Re: K111677
Trade/Device Name: Microscan(r) Microstrep Plus(r) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: LRG, JWY, LTW, JTZ
Dear Elisabeth Warriner:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 4, 2011. Specifically, FDA is updating this SE Letter because FDA has added a new product code (JTZ) to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ribhi Shawar, Ph.D., OHT7: Office of In Vitro Diagnostics and Radiological Health, (301-796-6698), ribhi.shawar@fda.hhs.gov.
Sincerely,
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Healthcare Diagnostics, Inc. c/o Ms. Jenifer Dawson Driscoll Regulatory Technical Specialist 1584 Enterprise Blvd. West Sacramento, CA 95691
2011 AUG
Re: K111677
Trade/Device Name: MicroScan®MICroSTREP plus Panels with Linezolid (0.12- 16 ug/mL) 21CFR 8866.1640 Regulation Number: Antimicrobial Susceptibility Test Powder Regulation Name: Regulatory Class: Class II Product Code: LRG, JWY, LTW Dated: May 31, 2011 Received: June 15, 2011
Dear Ms. Driscoll:
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 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 Parts 801 and 809); medical device reporting (reporting of
2
medical device-related adverse events) (21 CFR 803); 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. 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 Part 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/ReportalProblem/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 vours,
Hall athina
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
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Enclosure
3
Indications for Use
510(k) Number (if known): K | | 67
Device Name: MicroScan® MICroSTREP plus® with Linezolid (0.12 – 16 ug/ml)
Indications 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 visually. Alternatively, the panels can be incubated in and read by the MicroScan® WalkAway System, according to the Package insert.
This particular submission is for the addition of the antimicrobial agent Linezolid, at concentrations of 0.12 to 16 ug/mL, to the test panel.
The organisms which may be used for Linezolid susceptibility testing in this panel are:
Streptococcus pneumoniae including multi-drug resistant strains
Streptococcus pyogenes
Streptococcus agalactiae
Viridans group streptococci
Prescription Use _ V (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)
Reddit Coole
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111677
Page 1 of _1
പ്പ
4
K 111677
AUG - 4 2011
510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Siemens Healthcare Diagnostics |
|---|---|
| Contact name: | Jenifer Driscoll, Regulatory Technical Specialist |
| Fax: | 916-374-2545 |
| Date prepared: | May 26, 2011 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® MICroSTREP plus® Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Linezolid |
| Predicate device: | MicroScan MICroSTREP plus Panels - Levofloxacin (K020556) |
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 . aerobic streptococci, including Streptococcus pneumoniae.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water 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 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB), after inoculation of the broth with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Alternatively, the panel can be incubated in and read by the MicroScan® WalkAway System.
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 August 28, 2009. The Premarket Notification (510[k]) presents data in support of the MicroScan MICroSTREP plus Panel with Linezolid.
The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed MICroSTREP plus Panel by comparing its performance with a CLSI frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The MICroSTREP plus Panel demonstrated acceptable performance with an overall Essential Agreement of 97.2% for Linezolid when compared with the frozen Reference panel.
Reproducibility testing demonstrated acceptable reproducibility and precision with Linezolid, regardless of which read method (manual and WalkAway" instrument) was used with the turbidity inoculation method.
Quality Control testing demonstrated acceptable results for Linezolid.
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TPLC Detailed View
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Product Code Manufacturer Class Regulation Device Classification Device Name Date Last Listed
Not Listed
CDRH Gen Docs without Manufacturer (None)
Premarket Reviews Completed (None)
Under Review, Withdrawn or Closed without Product Code (None)
Standards and Guidance (None)
MDR Summary (None)
MDR Analyst (None)
MDR Distribution by Brand - Death or Injury (None)
Patient Problems (None)
Patient Outcomes (None)
Device Problems (None)
Manufacturer Evaluation Results (None)
Manufacturer Evaluation Conclusions (None)
Recalls (None)
Inspections (None)
CDRH Gen Docs without Manufacturer (None)
Rad Health Reports (None)
Rad Health Correspondence (None)
Rad Health Adverse Events (None)
Rad Health EIRs (None)