(20 days)
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 Ceftriaxone, at concentrations of 0.015 to 8 mcg/ml on the MicroScan MICroSTREP plus® Panel. The organisms which may be used for Ceftriaxone susceptibility testing in this panel are: Streptococcus pneumoniae Streptococcus pyogenes viridans group streptococci
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 µl 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.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Ceftriaxone) |
|---|---|
| Essential Agreement (Instrument read vs. Expected Result) | 99% |
| Reproducibility (Instrument to instrument) | Acceptable |
| Precision (Within instrument) | Acceptable |
| Quality Control | Acceptable |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated, however, the study involved "stock and CDC Challenge strains." The specific number of isolates used for evaluation is not provided.
- Data Provenance: Not explicitly stated, though the use of "CDC Challenge strains" suggests a potentially US-centric origin or at least strains relevant to US public health surveillance. The study appears to be prospective, as it's a comparison to "expected results determined before the evaluation."
3. Number and Qualifications of Experts for Ground Truth
- Not applicable as the ground truth was not established by human experts in the traditional sense of image interpretation or clinical diagnosis. The "expected result" was generated using a CLSI frozen Reference Panel, which is a standardized laboratory method.
4. Adjudication Method
- Not applicable, as the evaluation was a comparison against a standardized reference panel, not a consensus among human experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study focused on the standalone performance of the instrument read method against a reference standard. The document describes adding "instrument read capability," not assisting human readers.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance study was performed. The evaluation specifically compared the "proposed instrument read method" to "Expected Results" generated by a CLSI frozen Reference Panel, indicating an algorithm-only evaluation without human-in-the-loop performance being the primary focus. The purpose was to confirm the acceptability of the instrument's reading of the MICroSTREP plus Panel with Ceftriaxone.
7. Type of Ground Truth Used
- Reference Standard: The ground truth was established by an "expected result generated on a CLSI frozen Reference Panel," as defined in the FDA guidance document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA." This represents a standardized, laboratory-based reference method for determining antimicrobial susceptibility.
8. Sample Size for the Training Set
- The document does not explicitly mention a separate "training set" as it would for a machine learning model. The evaluation compares the instrument's performance against a reference standard, suggesting that the instrument's "reading" capabilities were either pre-calibrated or designed based on existing knowledge of AST methods, rather than being "trained" on a specific dataset in the modern AI sense. The stock and CDC Challenge strains were used for the evaluation of the instrument's performance.
9. How Ground Truth for the Training Set Was Established
- Not applicable given the nature of the device (an automated reader for a standardized test panel) and the absence of an explicit "training set" in the context of an AI model. The reference for performance was a CLSI frozen Reference Panel, which represents an established and validated method for determining antimicrobial susceptibility.
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Kolo30lo 4
OCT 26 2006
510(k) Summary Information:
| Device Manufacturer: | Dade Behring Inc. |
|---|---|
| Contact name: | Maureen Mende, Group Manager, Regulatory Affairs |
| 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 Ceftriaxone |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic streptococci |
| including Streptococcus pneumoniae | |
| Predicate device: | MicroScan MICroSTREP plus® Panel (K021110) |
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 µl 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 Ceftriaxone on the MicroScan® WalkAway instrument.
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 99% for Ceftriaxone instrument read results compared with the Expected Result.
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Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Ceftriaxone and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Ceftriaxone.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Re:
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Maureen Mende Group Manager, Regulatory Affairs Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972
OCT 2 6 2006
K063064 Trade/Device Name: MicroScan MICroSTREP plus® Panel Cefriaxone (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 6, 2005
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.
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 announcemer.ts 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 antrom
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.:
K063064 (To be assigned by FDA)
Device Name:
MicroScan MICroSTREP plus® Panel Ceftriaxone (0.015 - 8mcg/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 Ceftriaxone, at concentrations of 0.015 to 8 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Ceftriaxone susceptibility testing in this panel are:
Streptococcus pneumoniae Streptococcus pyogenes viridans group streptococci
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 (OIVD)
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Office of In Vitro Diagnostic Device Evaluation and Safety
- K06306Y
§ 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).