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 degrees C +/- 1 degree 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. This particular submission is for the addition of instrument read capability of the antimicrobial Tetracycline, at concentrations of 0.06 to 16 mcg/ml on the MicroScan MICroSTREP plus Panel. The organisms which may be used for Tetracycline susceptibility testing on this panel are: Streptococcus spp., Streptococcus pneumoniae.

Device Description

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 degrees C +/- 1 degree 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 varying concentrations in the wells of the panels. 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 test organism is usually read by observing the lowest antimicrobial concentration that inhibits visible growth of the test organism. Panels may be incubated in and read by a MicroScan WalkAway instrument.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroScan MICroSTREP plus® Panel with Tetracycline:

Acceptance Criteria and Device Performance

Acceptance Criteria (Not explicitly stated, but inferred from the FDA guidance)	Reported Device Performance (Tetracycline)
Substantially equivalent to CLSI frozen Reference Panel, as defined in "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003.	Overall Essential Agreement of 97.1% (instrument read results vs. Expected Result)
Acceptable reproducibility and precision (for instrument read)	Demonstrated acceptable reproducibility and precision
Acceptable Quality Control results	Demonstrated acceptable results

Note: The FDA guidance document likely specifies numerical thresholds for "Essential Agreement" and criteria for "acceptable reproducibility" and "acceptable Quality Control results." These specific numerical acceptance thresholds are not provided in the summary. The summary only states that the device met these acceptable criteria.

Study Information

Here's a breakdown of the study details based on the provided text:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a single number. The study utilized "stock and CDC Challenge strains." The text notes that the "proposed instrument read method for the MicroScan MICroSTREP plus® Panel demonstrated substantial equivalence with streptococcal isolates when compared with an expected Substantially Equivalent result generated on a CLSI frozen Reference Panel." While the types of strains are mentioned, the exact number of isolates used in the external evaluation for performance assessment is not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). The use of "CDC Challenge strains" suggests some US-based origin, but this isn't definitive for the entire "stock" collection. The study was an "external evaluation." It is implicitly prospective in the sense that new data was generated for this specific submission, comparing instrument reads to expected results.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The text does not specify the number of experts or their qualifications for establishing the "Expected Result" (ground truth). It refers to the "CLSI frozen Reference Panel" as the basis for the "Expected Result," implying that CLSI (Clinical and Laboratory Standards Institute) standards and potentially expert consensus or established methodologies were used to define these reference results.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. The "Expected Result" is associated with the "CLSI frozen Reference Panel," implying a standardized, reference-based determination rather than a multi-reader visual adjudication process.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. This study focuses on validating an instrument read method compared to an "Expected Result" based on a reference standard, not on human reader performance or improvement with AI assistance. The "instrument read method" is an automated reading by the MicroScan® WalkAway instrument, replacing or supplementing visual reading, rather than an AI-assisted human reading. The summary states panels "may be incubated in and read by a MicroScan® WalkAway instrument" in addition to visual reading, indicating it's an alternative or supplemental method, but not explicitly an AI-assisted human reading.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance evaluation of the "instrument read method" (referred to as the "proposed instrument read method" and instrument read results). The MicroScan® WalkAway instrument's reading is essentially an algorithm-only or automated standalone performance, independent of a human directly interpreting results for the performance metric of "Essential Agreement."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by "Expected Results determined [from] the CLSI frozen Reference Panel." This suggests a reference standard method (broth dilution susceptibility test, as described in the summary) and likely expert-developed CLSI guidelines. It's akin to a "gold standard" derived from established laboratory protocols and reference materials.
The sample size for the training set:
- Not applicable/Not provided. The text describes an evaluation or validation study for a device, not the development or training of a machine learning model. Therefore, a "training set" in the context of AI/ML is not relevant here. The device determines MIC values based on a pre-programmed methodology, not learned from a dataset.
How the ground truth for the training set was established:
- Not applicable (as it's not an AI/ML model with a training set).

Summary

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510(k) Summary Information:

OC1 1 3 2006

Device Manufacturer:	Dade Behring Inc.
Contact name:	Libby Warriner, Regulatory Affairs
Phone/Fax:	916-374-3244/916-374-3144
Date prepared:	September 20, 2006
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan MICroSTREP plus® Panel
Intended Use:	To determine bacterial susceptibility to Tetracycline
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 antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococi, allumicrolial agent subscopiesmer of occulation, panels are incubated for 20 – 24 hours at merading by option on on-CO2 incubator, and read according to the Package Insert.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. I he allimicrobial susceptions) collect in water, buffer or minute concentrations of broth to v anous animilieroom ugans are and interest. Panels are rehydrated with 115 ul Mueller-Concentrations origing are railly 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. ITES Los, atter inceculation of also erom were 20-24 hours, the minimum inhibitory concentration Alter inculture in a non CO2 mousaly read by observing the lowest antimicrobial concentration (INIC) for the test of gamels may be incubated in and be incubated in and read by a MicroScan® WalkAway instrument.

The proposed instrument read method for the MicroScan MICroSTREP plus® Panel demonstrated I he proposed instrantent read measure with streptococcal isolates when compared with an expected Substantally cqurrated on a CLSI frozen Reference Panel, as defined in the FDA document "Class II Special 16301 generated on a CEDERNEDA 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 Tetracycline on the MicroScan® WalkAway instrument.

The external evaluation was conducted with stock and CDC Challenge strains. The external I he catelliar were designed to confirm the acceptability of the proposed instrument read method for evaluations were designed to commission its performance with Expected Results determined the MICroof REP plus - Pailer of STREP plus Panel demonstrated acceptable performance with

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an overall Essential Agreement of 97.1% for Tetracycline instrument read results compared with the Expected Result.

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

Quality Control testing demonstrated acceptable results for Tetracycline.

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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 a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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: K062923

Trade/Device Name: MicroScan MICroSTREP plus® Panel Tetracycline (0.06 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 20, 2006 Received: September 28, 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 10(k) I his letter will anow you to begin marketing your as revivalence of your device to a legally premarked notification: "The PDTV mailing of bossification 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, II you desire specific information acour and advertising of your device, please contact the Office of In
or questions on the promotion and advertising of your and advanced th of questions on the promotion and Safety at (240)276-0450. Also, please note the Viro Diagnostic Device Evaluation and Sales to (21) = (21) = (21CFF Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification" (21CF). Alfremtha fegulation entitled, "Misoranding by folcrence to proder the Act may be obtained from the Other general information on your responsional 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 artman

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.:	K062923(To be assigned by FDA)
Device Name:	MicroScan MICroSTREP plus ® PanelTetracycline (0.06 to 16 mcg/ml)
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, and readvisually according to the Package Insert. Additionally, the panelsmay be incubated in and read by a MicroScan ® WalkAwayinstrument.
	This particular submission is for the addition of instrument readcapability of the antimicrobial Tetracycline, at concentrations of0.06 to 16 mcg/ml on the MicroScan MICroSTREP plus ® Panel.
	The organisms which may be used for Tetracycline susceptibilitytesting on this panel are:
Streptococcus spp.Streptococcus pneumoniae
Prescription UseX(Part 21 CFR 801 Subpart D)	AND/OROver-The-Counter Use(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IFNEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
	Division Sign-Off

Page 1 of _1

Office of In Vitro Diagnostic Device Onnee tion and Safety

510(k) | KD62923

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).