(22 days)
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No
The document describes a traditional broth dilution susceptibility test read visually or by an instrument, with no mention of AI or ML.
No
This device is an in vitro diagnostic (IVD) device used to determine antimicrobial agent susceptibility, not to deliver therapy directly to a patient.
Yes
The device is used to determine antimicrobial agent susceptibility, which is a diagnostic function to help guide treatment decisions by identifying which antibiotics will be effective against a specific bacterial infection.
No
The device is a physical panel used for antimicrobial susceptibility testing, which is incubated and read either manually or by a MicroScan WalkAway instrument. This involves physical components and biological processes, not solely software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is explicitly used to "determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci". This is a classic definition of an in vitro diagnostic test, as it analyzes biological samples (bacterial colonies) outside of the body to provide information for diagnosis and treatment decisions (determining which antibiotics will be effective).
- Device Description: The description details a laboratory test method involving rehydrating panels with broth, inoculating with a standardized suspension of the organism, incubating, and reading the minimum inhibitory concentration (MIC). This entire process is performed in vitro.
- Performance Studies: The performance studies compare the device's results with "Expected Results determined before the evaluation" and a "CLSI frozen Reference Panel". This type of validation is typical for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K021111) strongly indicates that this device is being submitted for regulatory clearance as a medical device, specifically an IVD, by comparing it to a previously cleared device.
Therefore, the MicroScan MICroSTREP plus® Panel, as described, is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: To determine bacterial susceptibility to Cefotaxime.
Indications for Use: 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 by a MicroScan® WalkAway instrument. To determine bacterial antimicrobial agent susceptibility. This particular submission is for the addition of instrument read capability of the antimicrobial Cefotaxime, at concentrations of 0.015 - 8 mcg/ml on the MicroScan MICroSTREP plus® Panel. The organisms which may be used for Cefotaxime susceptibility testing in this panel are: Streptococcus pneumoniae, Streptococcus pyogenes (Group A beta-hemolytic streptococci), Streptococcus spp.
Product codes (comma separated list FDA assigned to the subject device)
LRG, LTT
Device Description
The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative r no microbial 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 ℃ 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 Muellerecontractle 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
The evaluation was conducted with stock and CDC Challenge strains. The 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agreement of 93% for Cefotaxime instrument read results compared with the Expected Result. Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Cefotaxime and the WalkAway® instrument. Quality Control testing demonstrated acceptable results for Cefotaxime.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 93%
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® Panel (K021111)
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.
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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).
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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
KO63101
NOV - 1 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: | October 3, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan MICroSTREP plus® Panel |
| Intended Use: | To determine bacterial susceptibility to Cefotaxime |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic streptococci |
| including Streptococcus pneumoniae | |
| Predicate device: | MicroScan MICroSTREP plus® Panel (K021111) |
510(k) Summary:
The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative r no microbial 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 ℃ 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 Muellerecontractle 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 Cefotaxime on the MicroScan® WalkAway instrument.
1
The evaluation was conducted with stock and CDC Challenge strains. The 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 overall Essential Agreement of 93% for Cefotaxime instrument read results compared with the Expected Result.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Cefotaxime and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Cefotaxime.
2
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 caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff and two snakes intertwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Maureen Mende Regulatory Affairs Group Manager Dade Behring Inc. 2040 Enterprise Boulevard West Sacramento, CA 95691
NOV - 1 2006
Re: K063101
Trade/Device Name: MicroScan MICroSTREP plus® Panel Cefotaxime (0.015 - 8 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Code: LRG, LTT Dated: October 3, 2006 Received: October 10, 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, brug, 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, isting 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 not mean 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 frem mober (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sally, artur
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
4
Indication for Use Statement
510(k) No.:
K063101 (To be assigned by FDA)
Device Name:
MicroScan MICroSTREP plus® Panel Cefotaxime (0.015 - 8 mcg/ml)
Intended Use
The MicroScan MICroSTREP plus® Panel is used to determine Indications for Use: 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.
To determine bacterial antimicrobial agent susceptibility
This particular submission is for the addition of instrument read capability of the antimicrobial Cefotaxime, at concentrations of 0.015 -8 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Cefotaxime susceptibility testing in this panel are:
Streptococcus pneumoniae Streptococcus pyogenes (Group A beta-hemolytic streptococci) Streptococcus spp.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (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)
Division Sign-Off
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Office of In Vite Diagnostic Device Evaluation and is dety
K06 3101