For use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

This submission requests clearance of the following new Indication for Use:

Panels containing Cefpodoxime, Ceftazidime, Aztreonam Cefotaxime, or Ceftriaxone at 1 ug/ml can be used to screen for Escherichia coli, Klebsiella oxytoca, or K. pneumoniae strains suspected of producing extended-spectrum beta-lactamases (ESBLs).

An alternate method is required for confirmation testing.

Device Description

Microdilution Minimum Inhibitory Concentration (MIC) Panels. MicroScan® Dried Gram Negative MIC/Combo Panels with Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone.

AI/ML Overview

This document describes the acceptance criteria and the study conducted for MicroScan® Dried Gram Negative MIC/Combo Panels with certain antimicrobial agents to detect suspected Extended-Spectrum Beta-Lactamases (ESBLs) in specific bacterial strains.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in a quantitative format (e.g., minimum sensitivity/specificity thresholds). However, it implies acceptable performance based on reproducibility and quality control. The efficacy study aimed to confirm acceptability by comparing panel results against molecular characterization data.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Efficacy for ESBL Detection	Comparability of panel susceptibility results against molecular characterization data for ESBL and non-ESBL producing strains and AmpC-type strains. The goal is to confirm the acceptability of the MicroScan panels for detecting suspected ESBLs.	The "Efficacy study was designed to confirm the acceptability of the MicroScan® Dried Gram Negative Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents for detection of suspected ESBLs (E. coli, K. oxytoca, and K. pneumoniae) by comparing the panel susceptibility results against previously generated molecular characterization data." While the specific numerical agreement is not provided, the submission was cleared by the FDA, implying that the data presented demonstrated acceptable efficacy for the intended use of screening for suspected ESBLs.
Reproducibility (Inoculum and Instrument)	>95% agreement with the comparative system.	"Inoculum and instrument reproducibility testing with the MicroScan® Dried Gram Negative Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents demonstrated acceptable reproducibility with >95% of the results in agreement with the comparative system, regardless of which inoculum method (i.e., Turbidity, Log, and Prompt), or instrument (autoScan®-4 and WalkAway® System) was used."
Quality Control	Acceptable Quality Control throughout each phase of the ESBL evaluation.	"The MicroScan® Dried Gram Negative Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents demonstrated acceptable Quality Control throughout each phase of the ESBL evaluation."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document states that the efficacy testing was conducted with "ESBL and non-ESBL producing strains and AmpC-type strains." The exact number of strains used in the test set is not specified in the provided text.
Data Provenance: Not explicitly stated. The document refers to "previously generated molecular characterization data," but the origin (e.g., country, specific labs) is not detailed. The study itself appears to be conducted by Dade MicroScan Inc. (USA). The study is retrospective in the sense that molecular characterization data was "previously generated," and the panel results were compared against this existing data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The ground truth ("molecular characterization data") was "previously generated," but details on the experts involved in establishing this ground truth are absent.

4. Adjudication Method for the Test Set

This information is not provided. The comparison was against "previously generated molecular characterization data," implying a direct comparison rather than an adjudication process between human readers/interpreters within the scope of the device's performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study, as typically understood for human readers, was not performed. This study focuses on the in vitro diagnostic device's ability to detect ESBLs by comparing its results to a ground truth (molecular characterization data), not on how human readers perform with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this study represents a standalone performance evaluation of the MicroScan® Dried Gram Negative MIC/Combo Panels. The device itself (the panel and its interpretation via instrument) is being evaluated for its ability to detect ESBLs, independent of human interpretation or assistance beyond the standard operation of the instrument.

7. The Type of Ground Truth Used

The ground truth used was molecular characterization data. The document states, "...comparing the panel susceptibility results against previously generated molecular characterization data." This suggests genetic or biochemical testing to definitively identify ESBL-producing strains.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" or detail for algorithm development or machine learning. The study focuses on evaluating the performance of existing panels for a new indication for use. Therefore, no sample size for an algorithm training set is applicable or provided.

9. How the Ground Truth for the Training Set Was Established

Since no training set for an algorithm is discussed, this information is not applicable. The "previously generated molecular characterization data" served as the reference standard for the test set evaluation.

Summary

{0}------------------------------------------------

Attachment C

DADE MICROSCAN INC. 1584 Enterprise Boulevard West Sacramento, CA 95691 Tel: +1 (916) 372-1900

DADE BEHRING K981199

510(k) Submission Information:

Device Manufacturer:	Dade MicroScan Inc.
Contact name:	Sharolyn Lentsch, Regulatory Affairs Manager
Fax:	916-374-3144
Date prepared:	October 7, 1998
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® Dried Gram Negative MIC/Combo Panels with
	Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone-
510(k) Notification:	New Indication for Use
Reference method:	Molecular Characterization Tests

510(k) Summary:

MicroScan® Dried Gram Negative MIC/Combo Panels with Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone were cleared for susceptibility testing via Premarket Notification submissions. This Premarket Notification (510/kl) presents data in support of a request for a new indication for use (detection of suspected Escherichia coli, Klebsiella oxytoca, and K. pneumoniae extended spectrum beta-lactamases), similar to that described in the NCCLS documents M7-A4 and M100-S9.

Efficacy testing with MicroScan® Dried Gram Negative Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents was conducted with ESBL and non-ESBL producing strains and AmpC-type strains. The Efficacy study was designed to confirm the acceptability of the MicroScan® Dried Gram Negative Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents for detection of suspected ESBLs (E. coli, K. oxytoca, and K. pneumoniae) by comparing the panel susceptibility results against previously generated molecular characterization data.

Inoculum and instrument reproducibility testing with the MicroScan® Dried Gram Negative Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents demonstrated acceptable reproducibility with >95% of the results in agreement with the comparative system, regardless of which inoculum method (i.e., Turbidity, Log, and Prompt), or instrument (autoScan®-4 and WalkAway® System) was used.

The MicroScan® Dried Gram Negative Cefpodoxime, Ceftazidime, Aztreonam, Cefotaxime, Ceftriaxone antimicrobial agents demonstrated acceptable Quality Control throughout each phase of the ESBL evaluation.

{1}------------------------------------------------

Public Health Service

Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures. The figures are connected at the shoulders and appear to be reaching upwards.

NOV 1 8 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sharolyn J. Lentsch Regulatory Affairs Manager Dade Microscan, Inc./Dade Behring 1584 Enterprise Boulevard West Sacramento, California 95691

Re: K981199/S1 Trade Name: MicroScan® Dried Gram Negative MIC/Combo Panels Product Code: LRG Regulatory Class: II JWY II Dated: October 7, 1998 October 8, 1998 Received:

Dear Ms.Lentsch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Butman

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

{3}------------------------------------------------

Attachment E

Indications for Use Statement

510(k) No.:	To be assigned by FDA
Device Name:	MicroScan® Dried Gram Negative MIC/Combo PanelsCefpodoxime (0.015-64 ug/ml)Ceftazidime (0.5-64 ug/ml)Aztreonam (0.5-64 ug/ml)Cefotaxime (1*-64 ug/ml)Ceftriaxone (1-128 ug/ml)
	* 1 ug/ml will be for ESBL screening only. Performancecharacteristics with isolates other than E. coli and Klebsiellaspp., have not been established.
Intended Use:	For use in determining antimicrobial agent susceptibilityand/or identification to the species level of aerobic andfacultatively anaerobic gram-negative bacilli.
Indications for Use:	This submission requests clearance of the following newIndication for Use:
	Panels containing Cefpodoxime, Ceftazidime, AztreonamCefotaxime, or Ceftriaxone at 1 ug/ml can be used toscreen for Escherichia coli, Klebsiella oxytoca, orK. pneumoniae strains suspected of producing extended-spectrum beta-lactamases (ESBLs).

An alternate method is required for confirmation testing.

Woody Dubois

h-Off) ision of Clinical Laboratory Devices 510(k) Number

PRESCRIPTION USE X

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).