(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°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert.
This particular submission is for the addition of the antimicrobial Cefaclor at concentrations of 0.5 to 8 mcg/ml to the test panel
The organisms which may be used for Cefaclor 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.
Acceptance Criteria and Study Details for MicroScan® MICroSTREP plus™ Panel with Cefaclor
The MicroScan® MICroSTREP plus™ Panel's acceptance criteria and performance are based on its ability to accurately determine the minimum inhibitory concentration (MIC) for Cefaclor against Streptococcus pneumoniae.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Essential Agreement (EA) with Reference Panel: The device should demonstrate substantially equivalent performance to an NCCLS frozen Reference Panel. The FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (March 8, 2000) is referenced as defining acceptable performance. | Overall Essential Agreement (EA) > 98% with the frozen Reference panel. | This indicates a strong correlation between the device's MIC readings and the established reference standard. |
| Reproducibility: The device should demonstrate acceptable reproducibility and precision. | Acceptable reproducibility and precision demonstrated. | This confirms the device consistently produces similar results under the same conditions. Specific quantitative metrics for reproducibility are not provided in the summary. |
| Quality Control (QC) Testing: The device should produce acceptable results during quality control testing. | Acceptable results demonstrated for Cefaclor. | This indicates the device functions correctly within defined quality standards. Specific QC parameters and results are not provided in the summary. |
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 exact sample size (number of isolates/strains) used for the test set is not explicitly stated in the provided summary.
- Data Provenance: The data was generated through an "external evaluation." While the country of origin is not specified, it can be inferred that the studies were conducted within the context of FDA regulatory requirements, likely in the US or in conjunction with US-based standards (NCCLS). The study was prospective in the sense that it was designed to confirm the acceptability of the proposed panel by comparing its performance to a reference standard specifically for this submission.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1, none) for the test set. The comparison is made against an "NCCLS frozen Reference Panel," which implies that the reference panel itself serves as the established ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. The study focuses on the performance of the device itself against a reference standard, not on human reader improvement with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The external evaluation directly compares the performance of the MicroScan® MICroSTREP plus™ Panel (the algorithm/device) to the NCCLS frozen Reference Panel without human intervention affecting the core measurement of MIC. The MICs are "manually read by observing the lowest antimicrobial concentration showing inhibition of growth," meaning a human interprets the results of the device, but the device itself generates the dilutions and the growth patterns.
7. Type of Ground Truth Used
The type of ground truth used is an expert consensus reference standard, specifically an "NCCLS frozen Reference Panel." NCCLS (National Committee for Clinical Laboratory Standards, now Clinical and Laboratory Standards Institute - CLSI) panels are established based on validated methods and expert consensus to provide a reliable benchmark for antimicrobial susceptibility testing.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This is typical for devices that measure a specific biological parameter against a pre-existing reference. The "training" for such a device would likely involve R&D and optimization by the manufacturer, rather than a separate, identified training set for regulatory submission in the same way an AI model would have one.
9. How Ground Truth for the Training Set Was Established
As no training set is described in the context of this regulatory submission, the method for establishing its ground truth is not applicable and not provided.
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APR 3 0 2002
510(k) Summary Information:
| Device Manufacturer: | Dade MicroScan Inc. |
|---|---|
| Contact name: | Cynthia Van Duker, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | February 27, 2002 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® MICroSTREP plusTM Panel |
| Intended Use: | To determine bacterial susceptibility to Cefaclor |
| 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 (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.
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 MICroSTREP plus™ with Cefaclor.
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 MCCroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of >98% for Cefaclor when compared with the frozen Reference panel.
Reproducibility testing demonstrated acceptable reproducibility and precision with Cefaclor.
Quality Control testing demonstrated acceptable results for Cefaclor.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 3 0 2002
Ms. Cynthia Van Duker Regulatory Affairs Manager Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
K020691 Re:
K020071
Trade/Device Name: MicroScan® MICroSTREP plus™ Panels with Cefaclor Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: February 27, 2002 Received: March 4, 2002
Dear Ms. Van Duker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 ass button in the exerces, 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 rou may , arontrols provisions of the Act include requirements for annual registration, listing of general volures, 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 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 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 Part 801); good manufacturing practice requirements as set forth 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 Sutman
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:
KOZO6691 (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°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert.
This particular submission is for the addition of the antimicrobial Cefaclor at concentrations of 0.5 to 8 mcg/ml to the test panel
The organisms which may be used for Cefaclor 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-Off)
Division of Clinical Laboratory Devices
510(k) Number K020691
Prescription Use ✓
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
§ 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).