(59 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 Penicillin at concentrations of 0.015 to 16 mcg/ml to the test panel. The organisms which may be used for Penicillin susceptibility testing in this panel are: Streptococcus pneumoniae, Streptococci (Groups A, C, G, H, L and M).
The MicroScan® MICroSTREP plus™ 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 MicroScan® MICroSTREP plus™ Panel is intended to determine bacterial susceptibility to Penicillin by measuring the Minimum Inhibitory Concentration (MIC) for aerobic streptococci, including Streptococcus pneumoniae.
Here's a breakdown of the acceptance criteria and study details:
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (Penicillin) |
|---|---|
| Overall Essential Agreement >92% | >92% Essential Agreement |
| Acceptable reproducibility and precision | Demonstrated acceptable reproducibility and precision |
| Acceptable Quality Control results | Demonstrated acceptable Quality Control results |
2. Sample Size Used for the Test Set and Data Provenance:
The study used "fresh and stock Efficacy isolates and stock Challenge strains" for external evaluation. The exact sample size is not specified in the provided text. The data provenance is not explicitly stated in terms of country of origin, but the product and regulatory body are US-based, suggesting the data is likely from the US. The study involved both "fresh" isolates (prospective) and "stock" isolates/strains (retrospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not specify the number of experts or their qualifications involved in establishing the ground truth. It states that the performance was compared against an "NCCLS frozen Reference Panel." This implies the reference panel itself serves as the ground truth, and its creation would have involved standardized methods overseen by experts, though these details are not provided here.
4. Adjudication Method for the Test Set:
Not applicable. The comparison was made against a standardized "NCCLS frozen Reference Panel," which implicitly serves as an objective reference, rather than requiring expert adjudication of individual results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The device is for laboratory testing, not for human interpretation of medical images or other subjective inputs. Performance is compared against a reference panel.
6. If a Standalone Performance Study was Done:
Yes, a standalone performance study was done. The MicroScan® MICroSTREP plus™ Panel's performance was evaluated independently by comparing its results against an NCCLS frozen Reference Panel for Penicillin susceptibility.
7. Type of Ground Truth Used:
The ground truth used was a standardized NCCLS frozen Reference Panel. This panel provides a scientifically established and accepted reference for antimicrobial susceptibility testing.
8. Sample Size for the Training Set:
The document does not mention a separate "training set" for the device. The device is a diagnostic panel that directly performs the test, not an algorithm that requires training data in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set for this type of device. The device's performance is intrinsically linked to its chemical and biological design, and its "calibration" or validation is done by comparison to a recognized gold standard (the NCCLS reference panel).
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APR 2 6 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 25, 2002 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® MICroSTREP plus ™ Panel |
| Intended Use: | To determine bacterial susceptibility to Penicillin |
| Indication for Use | For determining antimicrobic susceptibility with aerobic streptococci, includingStreptococcus pneumoniae |
| Predicate device: | MicroScan® Streptococcus MIC Panel (K963641). |
510(k) Summary:
The MicroScan® MICroSTREP plus™ 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™ Panel with Penicillin.
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 >92% for Penicillin when compared with the frozen Reference panel.
Reproducibility testing demonstrated acceptable reproducibility and precision with Penicillin.
Quality Control testing demonstrated acceptable results for Penicillin.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of 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 figures, possibly representing people, with flowing lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Cynthia Van Duker Regulatory Affairs Manager Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
APR 2 6 2002
K020626 Re:
Ro20020
Trade/Device Name: MicroScan® MICroSTREP plus™ Panels with Penicillin 0.015-16μg/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: LTT Dated: February 25, 2002 Received: February 26, 2002
Dear Ms. Van Duker:
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 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 ' 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/cdrb/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.: | K020676(To be assigned by FDA) |
|---|---|
| Device Name: | MicroScan® MICroSTREP plus Panel |
| Intended Use | To determine bacterial antimicrobial agent susceptibility |
| Indications for Use: | The MicroScan® MICroSTREP plus™ Panel is used to determinequantitative and/or qualitative antimicrobial agent susceptibility ofcolonies grown on solid media of aerobic streptococci, includingStreptococcus pneumoniae . After inoculation, panels are incubatedfor 20 – 24 hours at 35°C +/- 1°C in a non-CO2 incubator, andread visually according to the Package Insert. |
This particular submission is for the addition of the antimicrobial
Penicillin at concentrations of 0.015 to 16 mcg/ml to the test panel
The organisms which may be used for Penicillin susceptibility
testing in this panel are:
Streptococcus pneumoniae
Streptococci (Groups A, C, G, H, L and M)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
tion (ODE)
Fiedler Poole
(Division Sign-Off) Division of Clinical Laboratory Devices
510(k) Number K020626
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Prescription Use
(Per 21 CFR 801.109) ✓
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).