(22 days)
MicroScan® MICroSTREP plus® Panel
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No
The summary describes a traditional broth dilution susceptibility test read manually or by an instrument. There is no mention of AI or ML in the device description, intended use, or performance studies. The instrument reading appears to be based on detecting growth inhibition, not complex pattern recognition or learning algorithms.
No.
The device determines antimicrobial agent susceptibility, which is a diagnostic function, not a therapeutic one.
Yes
The device determines bacterial antimicrobial agent susceptibility, which is a diagnostic function used to guide treatment decisions.
No
The device description explicitly mentions physical panels, broth, and incubation in a non-CO2 incubator or a MicroScan® WalkAway instrument, indicating hardware components are integral to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "determine bacterial antimicrobial agent susceptibility." This is a diagnostic test performed on a biological sample (bacterial colonies grown from a patient sample).
- Device Description: The device is a "miniaturization of the broth dilution susceptibility test," which is a standard laboratory method for determining how well antibiotics work against bacteria. It involves rehydrating panels with broth and inoculating them with a standardized suspension of the organism.
- Performance Studies: The performance studies compare the device's results to "Expected Results determined before the evaluation" and a "CLSI frozen Reference Panel." This indicates that the device is being evaluated for its accuracy in providing diagnostic information.
- Predicate Device: The predicate device is the "MicroScan® MICroSTREP plus® Panel," which is also an IVD. This suggests that the current submission is for a modification or update to an existing IVD.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. In this case, the information is about the susceptibility of bacteria to antimicrobial agents, which is crucial for guiding treatment decisions.
N/A
Intended Use / Indications for Use
To determine bacterial 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 visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.
This particular submission is for the addition of instrument read capability of the antimicrobial Clindamycin, at concentrations of 0.015 to 2 mcg/ml on the MicroScan MICroSTREP plus® Panel and the removal of the "Do not report" for S. pneumoniae.
The organisms which may be used for Clindamycin susceptibility testing on this panel are: Streptococci Streptococcus pneumoniae
Product codes
LRG, LTT
Device Description
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 according to the Package Insert.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. 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 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth 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 manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.
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
The proposed instrument read method for the MicroScan MICroSTREP plus® Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an expected result generated on a 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 February 5, 2003.
This Premarket Notification (510[k]) presents data in support of reading the MICroSTREP plus® Panel with Clindamycin on the MicroScan® WalkAway instrument.
The external evaluations conducted with CDC Challenge strains were designed to confirm the acceptability of the proposed instrument read method for the MICroSTREP plus® Panel by comparing its performance with Expected Results determined before the evaluation.
In addition, data on fresh and stock isolates is presented from the original external design validation of the manual method to support removing the "Do not report" limitation for S. pneumoniae with Clindamycin.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Clindamycin and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Clindamycin.
Key Metrics
The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agreement of ≥95.7% for Clindamycin compared with the Expected Result including S. pneumoniae.
Predicate Device(s)
MicroScan® MICroSTREP plus® Panel
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
(06277)
OCT 1 U 2006
510(k) Summary Information:
| Device Manufacturer: | Dade Behring Inc. |
|---|---|
| Contact name: | Maureen Mende, Regulatory Affairs Group Manager |
| Phone/Fax: | 916-374-3174/916-374-3144 |
| Date prepared: | August 28, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan MICroSTREP plus® Panel |
| Intended Use: | To determine bacterial susceptibility to Clindamycin |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic |
| streptococci including Streptococcus pneumoniae | |
| Predicate device: | MicroScan® MICroSTREP plus® Panel |
510(k) Summary:
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 according to the Package Insert.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. 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 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth 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 manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.
The proposed instrument read method for the MicroScan MICroSTREP plus® Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an expected result generated on a 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 February 5, 2003.
This Premarket Notification (510[k]) presents data in support of reading the MICroSTREP plus® Panel with Clindamycin on the MicroScan® WalkAway instrument.
The external evaluations conducted with CDC Challenge strains were designed to confirm the acceptability of the proposed instrument read method for the MICroSTREP plus® Panel by comparing its performance with Expected Results determined before the evaluation.
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In addition, data on fresh and stock isolates is presented from the original external design validation of the manual method to support removing the "Do not report" limitation for S. pneumoniae with Clindamycin.
The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agreement of ≥95.7% for Clindamycin compared with the Expected Result including S. pneumoniae.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Clindamycin and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Clindamycin.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Maureen Mende Regulatory Affairs Group Manager Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972
Re: K062777
Trade/Device Name: MicroScan MICroSTREP plus® Panel Clindamycin (0.015 to 2 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: August 28, 2006 Received: September 18, 2006
Dear Ms. Mende:
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.
OCT 1 0 2006
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 yours.
Sally, attorn
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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Indication for Use Statement
510(k) No .:
(To be assigned by FDA)
062777
MicroScan MICroSTREP plus® Panel Clindamycin (0.015 to 2 mcg/ml)
Intended Use
Indications for Use:
Device Name:
To determine bacterial 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 visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.
This particular submission is for the addition of instrument read capability of the antimicrobial Clindamycin, at concentrations of 0.015 to 2 mcg/ml on the MicroScan MICroSTREP plus® Panel and the removal of the "Do not report" for S. pneumoniae.
The organisms which may be used for Clindamycin susceptibility testing on this panel are:
Streptococci Streptococcus pneumoniae
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 (
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Devices (OIVD)
Ludalu L. Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Salery
510(k) K062777
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