(57 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℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial Cefuroxime at concentrations of 0.12 to 8 mcg/ml to the test panel. The organisms which may be used for Cefuroxime susceptibility testing in this panel are: 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. 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.
Here's an analysis of the acceptance criteria and study detailed in the provided document:
Acceptance Criteria and Device Performance Study
The MicroScan® MICroSTREP plus™ Panel with Cefuroxime is designed to determine the minimum inhibitory concentration (MIC) of Cefuroxime for Streptococcus pneumoniae. The primary study to demonstrate substantial equivalence compared the device's performance to an NCCLS frozen Reference Panel.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (from FDA DRAFT "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices") | Reported Device Performance (MicroScan® MICroSTREP plus™ Panel with Cefuroxime) |
|---|---|---|
| Overall Essential Agreement | Not explicitly stated in the provided text but implied to be high for substantial equivalence. | >99% for Cefuroxime when compared with the frozen Reference panel. |
| Reproducibility | Acceptable reproducibility and precision | Demonstrated acceptable reproducibility and precision with Cefuroxime. |
| Quality Control Testing | Acceptable results | Demonstrated acceptable results for Cefuroxime. |
Note: The specific numerical acceptance criteria for essential agreement, reproducibility, and quality control are not detailed in the provided text. The document states "acceptable performance" and "acceptable reproducibility/results" without numerical thresholds other than the Essential Agreement percentage.
2. Sample Size and Data Provenance
- Test Set Sample Size:
- The document refers to "fresh and stock Efficacy isolates and stock Challenge strains" for the external evaluation. However, the specific number of isolates/strains used is not provided in the summary.
- Data Provenance: The document does not explicitly state the country of origin. The test isolates included "fresh and stock Efficacy isolates and stock Challenge strains." It is implied that these were clinical isolates and standardized challenge strains, respectively. The study design was a prospective comparison against a reference standard.
3. Number of Experts and Qualifications for Ground Truth
- The document does not specify the number or qualifications of experts used to establish the ground truth. The ground truth (reference MIC values) was established using an NCCLS frozen Reference Panel. This implies that the reference panel itself underwent rigorous characterization, likely involving expert consensus and standardized protocols, but the details are not described in this submission. The device is read "visually" by a human, but this is the device's output, not the ground truth establishment.
4. Adjudication Method
- The document does not describe an adjudication method (e.g., 2+1, 3+1). The performance was compared directly to an NCCLS frozen Reference Panel, which serves as the established ground truth. Discrepancies between the device and the reference panel would traditionally be analyzed, but no specific adjudication process for these discrepancies is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done comparing human reader performance with and without AI assistance (or device assistance in this context). This device is a diagnostic panel that is read visually by a human. The study focuses on the accuracy of the panel itself in providing the MIC value compared to a reference method, not on the improvement of a human reader's diagnostic accuracy with the panel's assistance.
6. Standalone Performance Study
- Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done. The "MicroScan® MICroSTREP plus™ Panel" itself, when read visually according to instructions, constitutes the "device" whose performance was evaluated in comparison to the NCCLS frozen Reference Panel. While a human performs the visual reading, the performance evaluation is centered on the panel's ability to accurately present the MIC, not on the human's interpretation skills in isolation or with assistance. The comparison of the panel's results to a reference standard is a standalone assessment of the device's diagnostic output.
7. Type of Ground Truth Used
- The ground truth used was comparison to an NCCLS frozen Reference Panel. This type of ground truth represents a highly standardized and recognized reference method for antimicrobial susceptibility testing, considered the "gold standard" in the field at the time.
8. Sample Size for the Training Set
- The document does not explicitly describe a separate "training set" for the MicroScan® MICroSTREP plus™ Panel. As a diagnostic device for antimicrobial susceptibility, it is typically developed through extensive R&D and internal testing with various isolates. The provided submission describes the validation/testing of the market-ready device. Therefore, a specific "training set" sample size for an AI/algorithm context is not applicable or provided.
9. How the Ground Truth for the Training Set was Established
- Since a separate "training set" is not explicitly mentioned in the context of an AI/algorithm development and validation, the method for establishing its ground truth is not applicable or detailed. The device's underlying principles are based on established broth dilution susceptibility testing. Any internal development or calibration would have used similar laboratory reference methods to establish the 'true' MIC values for those internal isolates.
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MAY 0 9 2002
510(k) Summarv Information:
| Device Manufacturer: | Dade MicroScan Inc. |
|---|---|
| Contact name: | Cynthia Van Duker, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | March 12, 2002 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® MICroSTREP plus™ Panel |
| Intended Use: | To determine bacterial susceptibility to Cefuroxime |
| Indication for Use | For determining antimicrobic susceptibility with Streptococcus pneumoniae |
| Predicate device: | MicroScan® Streptococcus MIC Panel (K963641). |
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 visually 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 (1.HB) 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.
The proposed MicroScan® MICroSTREP plus™ Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000.
The Premarket Notification (510|k|) presents data in support of the new MCcoSTREP plus™ with Cefuroxime.
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 MICroSTREP plus™ Panel by comparing its performance with an NCCLS frozen Reference panel. The MCroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of >99% for Cefuroxime when compared with the frozen Reference panel.
Reproducibility testing demonstrated acceptable reproducibility and precision with Cefuroxime.
Quality Control testing demonstrated acceptable results for Cefuroxime.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are connected and appear to be part of a single, continuous line.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 0 9 2002
Ms. Cynthia Van Duker Regulatory Affairs Manager Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
K020820 Re:
Rozoozo
Trade/Device Name: MicroScan® MICroSTREP plus™ Panels with Cefuroxime 0.12-8 ug/ml.
Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: March 12, 2002 Received: March 13, 2002
Dear Ms. Van Duker:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becaller of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass bared in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conmision provision of the J 2005 and with the provisions of the Federal Food, Drug, do noos mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may , are s 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 If your de reast additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 r four ove active 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
510(k) No .:
Device Name:
Intended Use
Indications for Use:
K020820 (To be assigned by FDA)
MicroScan® MICroSTREP plus™ Panel
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℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert.
This particular submission is for the addition of the antimicrobial Cefuroxime at concentrations of 0.12 to 8 mcg/ml to the test panel
The organisms which may be used for Cefuroxime susceptibility testing in this panel are:
Streptococcus pneumoniae
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign- | |
|---|---|
| Division of Cli | atory Devices |
| 510(k) Number | k0 20826 |
|---|---|
| --------------- | ---------- |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) | OR |
| Over-The-Counter Use |
(Optional Format 1-2-96)
8
§ 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).