(80 days)
The MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 4.5 - 18 hours at 35℃ +/- 1℃, in a WalkAway SI or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the AST portions can be read visually, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Cefazolin, at concentrations of 0.5 to 32 ug/ml, to the test panel.
The gram-negative organisms which may be used for Cefazolin susceptibility testing in this panel are:
Escherichia coli Klebsiella spp. Proteus mirabilis
The MicroScan® Synergies plus" Gram-Negative Panels with Cefazolin is not intended for use with:
- Klebsiella oxytoca Enterobacter spp. Citrobacter freundii Morganella morganii Proteus vulgaris
Proteus penneri Providencia spp Serratia spp Yersinia enterolitica
MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (AST) technologies, are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® S7 System or equivalent for 4.5 - 18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.
The MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Cefazolin are designed to determine antimicrobial agent susceptibility. The device's performance was compared to an NCCLS frozen Reference Panel.
Here's a breakdown of the acceptance criteria and the study details:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Essential Agreement) | Reported Device Performance (Cefazolin) |
|---|---|
| >97% Essential Agreement | >97% Essential Agreement |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" but does not specify the exact number of samples used for the external evaluation.
- Data Provenance: The document does not explicitly state the country of origin. The study was a "external evaluation." It utilized both "fresh and stock Efficacy isolates" (implying a mix of recent clinical samples and archived ones) and "stock Challenge strains" (controlled, known strains). This suggests a mixed approach, potentially incorporating both retrospective and prospective elements for the "efficacy isolates" and a controlled retrospective aspect for the "challenge strains."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts or their qualifications. The "Expected Results" for the Challenge strains were determined prior to the evaluation, which implies expert consensus or adherence to established standards, but explicit details are not given.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method. It compares the device's performance to an "NCCLS frozen Reference panel" and "Expected Results" for challenge strains. This suggests the reference panel and expected results served as the "ground truth" against which the device was evaluated, rather than an adjudication process between different readers or methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of the automated system against a reference method, not on human reader improvement with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone study was done. The document describes the "external evaluation" where the MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel's performance was compared directly with an NCCLS frozen Reference Panel and Expected Results for challenge strains. This is a standalone evaluation of the algorithm/device's performance.
7. Type of Ground Truth Used
The ground truth used was primarily a reference standard: an "NCCLS frozen Reference panel" for efficacy isolates and "Expected Results" for challenge strains. The NCCLS (National Committee for Clinical Laboratory Standards, now Clinical and Laboratory Standards Institute - CLSI) sets recognized standards for antimicrobial susceptibility testing, making their reference panel a strong gold standard.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. The description focuses on the evaluation of the device's performance after its development. It's likely that proprietary data was used for developing and training the underlying algorithms, but these details are not provided in the 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any potential training set was established.
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JUL 2 2 2004
510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Dade Behring Inc. |
|---|---|
| Contact name: | Robert Eusebio, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | May 19, 2003 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Cefazolin |
| Predicate device: | MicroScan® Synergies plus™ Gram Negative MIC/Combo Panels |
510(k) Summary:
MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (AST) technologies, are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® S7 System or equivalent for 4.5 - 18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.
The proposed MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with an NCCLS 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 Premarket Notification (510)kl) presents data in support of the MicroScan® Synergies plus Gram-Negative MIC/Combo Panel with Cefazolin.
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 Synergies plus Gram-Negative Panel by comparing its performance with an NCCLS frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The Synergies plus Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of >97% for Cefazolin when compared with the frozen NCCLS Reference panel.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Turbidity inoculum preparation method and the WalkAway® SY System or equivalent. An additional reproducibility study was performed to obtain additional rapid (<16 hour) results (Attachment 3) per the request of FDA.
Quality Control testing demonstrated acceptable results for Cefazolin.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
JUL 22 2004
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
Mr. Robert Eusebio Regulatory Affairs Manager Dade Behring Dade MicroScan Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
K041150 Re:
K041150
Trade/Device Name: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels Cefazolin (0.5 - 32 µg/ml)
Regulation Number: 21 CFR 866.1645
Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system.
Regulatory Class: Class II Product Code: LRG, LON Dated: April 26, 2004 Received: May 11, 2004
Dear Mr. Eusebio:
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 commence 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).
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Page 2
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Saqartys
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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Indications for Use Statement
k 041150 510(k) Number (if known):
Device Name: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Cefazolin (0.5 - 32 ug/ml,)
Indications For Use:
The MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 4.5 - 18 hours at 35℃ +/- 1℃, in a WalkAway SI or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the AST portions can be read visually, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Cefazolin, at concentrations of 0.5 to 32 ug/ml, to the test panel.
The gram-negative organisms which may be used for Cefazolin susceptibility testing in this panel are:
Escherichia coli Klebsiella spp. Proteus mirabilis
The MicroScan® Synergies plus" Gram-Negative Panels with Cefazolin is not intended for use with:
- Klebsiella oxytoca Enterobacter spp. Citrobacter freundii Morganella morganii Proteus vulgaris
Proteus penneri Providencia spp Serratia spp Yersinia enterolitica
Prescription Use (Part 21 CFR 801 Subpart D)
Cfz510k a.doc
Over-The-Counter Use 21 CFR 807 Subpart C)
viii
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDEL
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Lueddu Pady
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041150
§ 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).