(18 days)
Not Found
No
The document describes a traditional broth dilution susceptibility test system and an instrument for automated reading, but there is no mention of AI or ML in the intended use, device description, or performance studies. The reading is based on observing growth inhibition, either visually or by the instrument, not through AI/ML algorithms.
No
This device is an antimicrobial susceptibility test system used to determine which antibiotics will be effective against bacterial infections, not to provide therapy itself.
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, incubation, and the option of using a MicroScan WalkAway instrument, indicating hardware components are integral to the device's function. The submission is for adding instrument read capability, which is a software feature for a hardware-based system.
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 sample (bacterial colonies) taken from a patient to provide information about their health status (specifically, how susceptible the bacteria causing an infection are to different antibiotics).
- Device Description: The device is a "miniaturization of the broth dilution susceptibility test," which is a standard laboratory method for determining antimicrobial susceptibility. It involves rehydrating panels with broth and a standardized suspension of the organism, incubating them, and then reading the minimum inhibitory concentration (MIC). These are all characteristic steps of an in vitro diagnostic test.
- Sample Type: The test is performed on "colonies grown on solid media of aerobic streptococci," which are biological samples derived from a patient.
The fact that it is used to determine the susceptibility of bacteria to antimicrobial agents directly relates to diagnosing and guiding treatment for infections, which falls squarely under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To determine bacterial susceptibility to Amoxicillin/Clavulanic Acid
For determining antimicrobic susceptibility with aerobic streptococci including Streptococcus pneumoniae
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 Amoxicillin/Clavulanic Acid, at concentrations of 0.015/0.008 to 16/8 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Amoxicillin/Clavulanic Acid susceptibility testing in this panel are: 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
Not Found
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
The external evaluation was conducted with stock and CDC Challenge strains. The external evaluations 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.
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.
The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agreement of 98.1% for Amoxicillin/Clavulanic Acid instrument read results compared with the Expected Result.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Amoxicillin/Clavulanic Acid and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Amoxicillin/Clavulanic Acid.
Key Metrics
Essential Agreement of 98.1% (for Amoxicillin/Clavulanic Acid instrument read results compared with the Expected Result).
Predicate Device(s)
MicroScan MICroSTREP plus® Panel (K020937)
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).
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510(k) Summary Information:
SEP 1 9 2006
| Device Manufacturer: | Dade Behring Inc. |
|---|---|
| Contact name: | Shannon Popson, Regulatory Affairs Manager |
| Phone/Fax: | 916-374-3330/916-374-3144 |
| Date prepared: | August 17, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan MICroSTREP plus® Panel |
| Intended Use: | To determine bacterial susceptibility to Amoxicillin/Clavulanic Acid |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic streptococci |
| including Streptococcus pneumoniae | |
| Predicate device: | MicroScan MICroSTREP plus® Panel (K020937) |
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 Amoxicillin/Clavulanic Acid on the MicroScan® WalkAway instrument.
The external evaluation was conducted with stock and CDC Challenge strains. The external evaluations 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. The MICroSTREP plus® Panel demonstrated acceptable performance with an
1
overall Essential Agreement of 98.1% for Amoxicillin/Clavulanic Acid instrument read results compared with the Expected Result.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Amoxicillin/Clavulanic Acid and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Amoxicillin/Clavulanic Acid.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its wings spread, and a ribbon-like element flowing beneath it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Shannon Popson Regulatory Affairs Manager Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972
SEP 1 9 2006
K062596 Re:
Trade/Device Name: MicroScan MICroSTREP plus® Panel Amoxicillin/Clavulanic Acid (0.015/0.008-16/8 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: August 18, 2006 Received: September 1, 2006
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 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).
3
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 autry
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.:
KO 62596 (To be assigned by FDA)
Device Name:
MicroScan MICroSTREP plus® Panel Amoxicillin/Clavulanic Acid (0.015/0.008 - 16/8 mcg/ml)
To determine bacterial antimicrobial agent susceptibility
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 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 Amoxicillin/Clavulanic Acid, at concentrations of 0.015/0.008 to 16/8 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Amoxicillin/Clavulanic Acid susceptibility testing in this panel are:
Streptococcus pneumoniae
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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