(25 days)
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.
To determine bacterial antimicrobial agent susceptibility
This particular submission is for the addition of instrument read capability of the antimicrobial Penicillin, at concentrations of 0.015 to 16 mcg/ml on the MicroScan MICroSTREP plus® Panel.
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. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. The antimicrobial agents are diluted in water, buffer or minute concentrations of broth to various concentrations. Panels are rehydrated with 115 ul Mueller Hinton Broth 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 organism is read by observing the lowest antimicrobial concentration that inhibits visible growth.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Criteria (Metric) | Acceptance Threshold (Goal) | Reported Device Performance |
|---|---|---|
| Essential Agreement (EA) | Acceptable performance 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. | 98.6% for Penicillin instrument read results compared with Expected Result. |
| Instrument Reproducibility | Acceptable | Demonstrated acceptable reproducibility and precision. |
| Quality Control Testing | Acceptable | Demonstrated acceptable results for Penicillin. |
Note: The FDA guidance document mentioned for Essential Agreement (February 5, 2003) would contain the specific numerical thresholds for "acceptable performance." Without access to that document, the exact numerical threshold can't be filled in, but the device explicitly states it met this criteria.
Study Details
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "stock and CDC Challenge strains" were used for the external evaluation. However, the exact number of strains or individual isolates tested is not specified in the provided text.
- Data Provenance: The study was an "external evaluation" conducted with "stock and CDC Challenge strains." This suggests a controlled laboratory setting, likely with well-characterized strains from established repositories like the CDC. It is a prospective evaluation designed to assess the new instrument's performance against established methods. The country of origin for the data is not explicitly stated, but given the FDA submission and CDC strains, it's highly likely to be the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
The "Expected Results" were determined by the company's MicroScan MICroSTREP plus® Panel. This implies that the standard, predicate method (read visually or by a human) was used to establish the ground truth. While experts would be involved in interpreting those results, the specific number and qualifications are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: The ground truth was established by "Expected Results determined [from] the MicroScan MICroSTREP plus® Panel" (likely the predicate device's standard method). This suggests a comparative method rather than typical expert adjudication. The text does not describe a specific adjudication method like 2+1 or 3+1. It's an "external evaluation" where the instrument's performance is compared against these predetermined "Expected Results."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not explicitly described in the provided text. The study focused on the performance of the instrument-read method compared to "Expected Results" from the predicate device, not on comparing human readers with and without AI assistance.
- Effect Size of Human Improvement: Therefore, no effect size for human readers with and without AI assistance is provided.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Yes, a standalone performance evaluation was conducted. The entire study describes the performance of the "proposed instrument read method" (the MicroScan® WalkAway instrument reading the panels) for Penicillin, without explicit human intervention in the reading process that is being evaluated. The device itself is the "algorithm only" component being assessed for reading the MIC panels.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used was established by the "Expected Results determined [from] the MicroScan MICroSTREP plus® Panel." This refers to the results obtained from the predicate method (which can be read visually or by a WalkAway instrument, but for the purpose of establishing ground truth for the new instrument-read claim, it would be the established/validated method). This is a form of expert consensus/established method comparison, where the predicate device's validated results serve as the reference standard.
8. Sample Size for the Training Set
- Sample Size for Training Set: The document does not provide any information about a training set or its sample size. This type of device (an automated reader for MIC panels) is typically validated through comparison to known reference methods with a test set, rather than "training" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Since no training set is mentioned, information on how its ground truth was established is not applicable.
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510(k) Summary Information:
| Device Manufacturer: | Dade Behring Inc. | OCT 13 2006 |
|---|---|---|
| Contact name: | Libby Warriner, Regulatory Affairs | |
| Phone/Fax: | 916-374-3244/916-374-3144 | |
| Date prepared: | September 7, 2006 | |
| 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 including Streptococcus pneumoniae | |
| Predicate device: | MicroScan® MICroSTREP plus® Panel |
510(k) Summary:
The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative I he Microbial agent susceptibility of colonies grown on solid media of aerobic streptococi, anumicronal agent susceptionity of octories growation, panels are incubated for 20 – 24 hours at meluding bireplocouss prominent.
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. I the antimicrobial agents are diluted in water, buffer or minute concentrations of broth to various animilierooms are anatos are unterest. Panels are rehydrated with 115 ul Muellerconcentrations only the railige of % 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 After inculture in a non CO2 measures ead by observing the lowest antimicrobial concentration (IVIC) For the torganism 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 I I le proposed instrument read mone with streptococcal isolates when compared with an expected substantially cqurvalent performance was se Panel, as defined in the FDA document "Class II Special IControls 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 Penicillin on the MicroScan® WalkAway instrument.
The external evaluation was conducted with stock and CDC Challenge strains. The external I he external evaluation was confirm the acceptability of the proposed instrument read method for the MICroSTREP plus® Panel by comparing its performance with Expected Results determined the MICros I KL. 'pris' I uner of company is Panel demonstrated acceptable performance with
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an overall Essential Agreement of 98.6% for Penicillin instrument read results compared with the Expected Result.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Penicillin and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Penicillin.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is an abstract representation of a human figure, with three overlapping profiles facing to the right. The profiles are stylized and appear to be connected, possibly symbolizing unity or collaboration.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Libby Warriner Regulatory Affairs/Quality Systems Compliance Senior Specialist Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972
OCT 1 3 2006
Re: K062773 Trade/Device Name: MicroScan MICroSTREP plus® Panel Penicillin (0.015 to 16 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: September 7, 2006 Received: September 18, 2006
Dear Ms. Warriner:
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 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms icter wif anow you'ls ought finding of substantial equivalence of your device to a legally premarket notification. "The sults 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, If you destions on the promotion and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240)276-0450. Also, please note the vitto Diagnostic Dories Drananding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general information on Jour versational 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, attorn
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 .:
K062173 (To be assigned by FDA)
MicroScan MICroSTREP plus® Panel Penicillin (0.015 to 16 mcg/ml)
Intended Use
Device Name:
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.
To determine bacterial antimicrobial agent susceptibility
This particular submission is for the addition of instrument read capability of the antimicrobial Penicillin, at concentrations of 0.015 to 16 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Penicillin susceptibility testing on this panel are:
Streptococcus pneumoniae Streptococci (Groups A, C, G, H, L, and M) Streptococcus agalactiae Viridans 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)
Freddie M. Poole
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Sufety
K06 2773
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§ 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).