MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML by DADE BEHRING, INC.

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 Cefotaxime, at concentrations of 0.015 -8 mcg/ml on the MicroScan MICroSTREP plus® Panel.

The organisms which may be used for Cefotaxime susceptibility testing in this panel are:

Streptococcus pneumoniae Streptococcus pyogenes (Group A beta-hemolytic streptococci) Streptococcus spp.

Device Description

The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative r no microbial 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 ℃ in a non-CO2 incubator, and read 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 Muellerecontractle 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. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MicroScan MICroSTREP plus® Panel with Cefotaxime, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Overall Essential Agreement with Expected Result	93% Essential Agreement for Cefotaxime instrument read results compared with the Expected Result
Instrument Reproducibility	Demonstrated acceptable reproducibility and precision
Quality Control Testing	Demonstrated acceptable results for Cefotaxime

Note: The specific numerical target for "acceptable" essential agreement and other metrics is not explicitly stated but is implicitly met by the reported 93% and "acceptable" statements. The reference to the "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003, would contain the detailed numerical acceptance criteria.

Study Information

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The text states "The evaluation was conducted with stock and CDC Challenge strains." However, the exact number of strains or isolates used in the test set is not specified in the provided document.
Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not explicitly stated, but the phrase "The evaluations were designed to confirm the acceptability of the proposed instrument read method... by comparing its performance with Expected Results determined before the evaluation" suggests a prospective comparison against pre-defined expected results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
Role of Experts: The ground truth was referred to as "Expected Results determined before the evaluation" and was based on "a CLSI frozen Reference Panel." This implies the ground truth was established by a recognized standard methodology (CLSI) and likely involved expert consensus in establishing the reference panel.

4. Adjudication method for the test set:

Adjudication method is not specified. The comparison was against "Expected Results determined before the evaluation" and a "CLSI frozen Reference Panel."

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This study focuses on validating the instrument-read capability of an antimicrobial susceptibility test panel against a predicate device/reference standard, not on human-AI collaboration or improvement with AI assistance. The "instrument read method" refers to the automated reading by the MicroScan WalkAway instrument.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, a standalone performance study was done. The entire premise of the submission is to validate the "instrument read method" (MicroScan WalkAway instrument) for the MICroSTREP plus® Panel for Cefotaxime. This is a standalone assessment of the automated instrument's performance in reading the Minimum Inhibitory Concentration (MIC) values.

7. The type of ground truth used:

The ground truth used was Expert Consensus/Reference Standard. It was based on "Expected Results determined before the evaluation" which were generated on a "CLSI frozen Reference Panel." The CLSI (Clinical and Laboratory Standards Institute) provides recognized standards for microbiology testing, and reference panels are established through rigorous testing and expert consensus to provide a reliable "true" value.

8. The sample size for the training set:

Not applicable/Not specified. This type of device (Antimicrobial Susceptibility Test System based on broth microdilution) typically does not involve a "training set" in the machine learning sense. The "training" of the instrument is inherent in its design and calibration for reading growth inhibition, rather than a data-driven training phase to learn a specific task. The validation focuses on the instrument's performance against established reference methods.

9. How the ground truth for the training set was established:

Not applicable/Not specified. As mentioned above, a "training set" in the AI sense is not relevant for this device.

Summary

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KO63101

NOV - 1 2006

510(k) Summary Information:

Device Manufacturer:	Dade Behring Inc.
Contact name:	Maureen Mende, Regulatory Affairs, Group Manager
Phone/Fax:	916-374-3174/916-374-3144
Date prepared:	October 3, 2006
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan MICroSTREP plus® Panel
Intended Use:	To determine bacterial susceptibility to Cefotaxime
Indication for Use:	For determining antimicrobic susceptibility with aerobic streptococciincluding Streptococcus pneumoniae
Predicate device:	MicroScan MICroSTREP plus® Panel (K021111)

510(k) Summary:

The proposed instrument read method for the MicroScan MICroSTREP plus® Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an expected result generated on a CLSI 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.

This Premarket Notification (510[k]) presents data in support of reading the MICroSTREP plus Panel with Cefotaxime on the MicroScan® WalkAway instrument.

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The evaluation was conducted with stock and CDC Challenge strains. The evaluations were designed to confirm the acceptability of the proposed instrument read method for the MICroSTREP plus® Panel by comparing its performance with Expected Results determined before the evaluation. The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agreement of 93% for Cefotaxime instrument read results compared with the Expected Result.

Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Cefotaxime and the WalkAway® instrument.

Quality Control testing demonstrated acceptable results for Cefotaxime.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Maureen Mende Regulatory Affairs Group Manager Dade Behring Inc. 2040 Enterprise Boulevard West Sacramento, CA 95691

NOV - 1 2006

Re: K063101

Trade/Device Name: MicroScan MICroSTREP plus® Panel Cefotaxime (0.015 - 8 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Code: LRG, LTT Dated: October 3, 2006 Received: October 10, 2006

Dear Ms. Mende:

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, brug, 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, isting 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 not mean 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) 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 (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 frem mober (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sally, artur

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.:

K063101 (To be assigned by FDA)

Device Name:

MicroScan MICroSTREP plus® Panel Cefotaxime (0.015 - 8 mcg/ml)

Intended Use

The MicroScan MICroSTREP plus® Panel is used to determine Indications for Use: 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 Cefotaxime, at concentrations of 0.015 -8 mcg/ml on the MicroScan MICroSTREP plus® Panel.

The organisms which may be used for Cefotaxime susceptibility testing in this panel are:

Streptococcus pneumoniae Streptococcus pyogenes (Group A beta-hemolytic streptococci) Streptococcus spp.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (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)

Division Sign-Off

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Office of In Vite Diagnostic Device Evaluation and is dety

K06 3101

Regulation Number and Section

§ 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).