DRIED GRAM-POSITIVE MIC/COMBO PANELS

• K Number: K993102
• Device Name: DRIED GRAM-POSITIVE MIC/COMBO PANELS
• Manufacturer: DADE MICROSCAN, INC.
• Date Cleared: 1999-12-02 ( 77 days)
• Product Code: LTT
• Regulation Number: 866.1640
• Type: Traditional
• Panel: Microbiology
• Reference & Predicate Devices: K983408
• Predicate For: N/A

Intended Use

To determine gram-positive bacterial susceptibility to the antimicrobial agent Synercid.

Organisms with indications for testing include:

FROM THE INDICATION FOR USE SECTION OF THE MANUFACTURER'S PACKAGE INSERT (7-14-99)

Methicillin-susceptible Staphylococcus aureus Vancomycin resistant Enterococcus faecium Streptococcus pyogenes (Gp.A)

FROM THE MICROBIOLOGY SECTION OF THE MANUFACTURER'S PACKAGE INSERT (7-14-99).

Streptococcus agalactiae (Gp.B) Methicillin-resistant Staphylococcus aureus Staphylococcus epidermidis

The MicroScan® Dried Gram-Positive MIC/Combo Panels with Synercid are not intended for use with Streptococcus pneumoniae and viridans streptococci.

Device Description

Microdilution Minimum Inhibitory Concentration (MIC) Panel

AI/ML Overview

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

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Overall Essential Agreement with NCCLS frozen Synercid Reference Panel	98.4%
Reproducibility for inoculum methods (Turbidity and Prompt)	Acceptable
Reproducibility for instruments (autoScan-4 and WalkAway®)	Acceptable
Quality Control Performance	Acceptable

Note: The specific numerical thresholds for "acceptable" reproducibility and Quality Control performance are not provided in the document.

Study Details

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

   • The study used "fresh and stock Efficacy isolates and stock Challenge strains" for external evaluations.
   • The exact sample size (number of isolates/strains) is not specified.
   • The provenance is not explicitly stated (e.g., country of origin) but the study was an "external evaluation," implying independent data collection. The data is retrospective, as "stock isolates" and "stock challenge strains" were used.

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

   • Not applicable/Not mentioned. The ground truth was established by comparison to a "NCCLS frozen Synercid Reference panel," which is a standardized method, not human expert consensus.

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. The comparison was against a reference panel, not requiring human adjudication of discrepancies.

4. 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. This study is for an antimicrobial susceptibility testing (AST) panel, which is a laboratory device, not an AI-based diagnostic tool for human readers.

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

   • Yes, this was a standalone performance study of the device (MicroScan® Dried Gram-Positive MIC/Combo Panels with Synercid). Its performance was compared directly to a "NCCLS frozen Synercid Reference panel." The "human-in-the-loop" aspect would involve the lab technician performing the test, but the evaluation is of the device's output accuracy against a reference.

6. The type of ground truth used:

   • Reference Standard: The ground truth was established by an "NCCLS frozen Synercid Reference panel." This is a recognized and standardized reference method for antimicrobial susceptibility testing.

7. The sample size for the training set:

   • Not applicable. This device is a diagnostic testing panel, not an AI model that requires a training set in the conventional sense. The "training" of such a device is in its manufacturing and calibration process, not through a data-driven model training phase.

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

   • Not applicable, as there is no training set in the context of an AI model. The device's design and manufacturing rely on established microbiological and chemical principles, with performance validated against reference standards.

Summary

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DEC - 2 1999

510(k) Summary

510(k) Submission Information:

Device Manufacturer:	Dade MicroScan Inc.
Contact name:	Trevor Wall, Regulatory Affairs Manager
Fax:	916-374-3144
Date prepared:	September 10, 1999
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panel
Trade Name:	MicroScan® Dried Gram-Positive MIC/Combo Panels
Intended Use:	To determine microbial susceptibility to Synercid
510(k) Notification:	New antimicrobial - Synercid
Predicate device:	Microscan Dried Panels e.g. Trovafloxacin (K983408)

510(k) Summary:

The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel with Synercid demonstrated substantially equivalent performance when compared with an NCCLS frozen Synercid Reference Panel, as defined in the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991).

The Premarket Notification (510[k]) presents data in support of the new antimicrobial, Quinupristin/Dalfopristin (Synercid), for the MicroScan® Dried Gram Positive MIC/Combo Panels.

The gram-positive external evaluations were conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Dried Synercid panels by comparing their performance with an NCCLS frozen Synercid Reference panel.

The Dried gram-positive Synercid panel demonstrated acceptable performance with an overall Essential Agreement of 98.4% when compared with the frozen Synercid Reference panel.

Inoculum and instrument reproducibility testing was conducted; the gram-positive Dried Synercid panels demonstrated acceptable reproducibility and precision, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoScan-4 and WalkAway®) was used.

Quality Control performance was acceptable for the gram-positive Dried Synercid panels.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and head.

DEC - 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Trevor Wall Regulatory Affairs Manager Dade Microscan, Inc. 1584 Enterprise Boulevard West Sacramento, California 95691

Re: K993102 Trade Name: MicroScan® Dried Gram-Positive MIC/Combo Panels (Synercid) Regulatory Class: II Product Code: LTT Dated: September 14, 1999 Received: September 16, 1999

Dear Mr. Wall:

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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 assumptions. Failure to comply with the GMP regulation may result in regulatory 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.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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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Intended Use Statement

510(k) No.:

Device Name:

Indications for Use:

K993102

MicroScan® Dried Gram-Positive MIC/Combo Panels with Synercid (0.06 - 4 mcg/ml on the gram-positive panels)

To determine gram-positive bacterial susceptibility to the antimicrobial agent Synercid.

Organisms with indications for testing include:

FROM THE INDICATION FOR USE SECTION OF THE MANUFACTURER'S PACKAGE INSERT (7-14-99)

Methicillin-susceptible Staphylococcus aureus Vancomycin resistant Enterococcus faecium Streptococcus pyogenes (Gp.A)

FROM THE MICROBIOLOGY SECTION OF THE MANUFACTURER'S PACKAGE INSERT (7-14-99).

Streptococcus agalactiae (Gp.B) Methicillin-resistant Staphylococcus aureus Staphylococcus epidermidis

The MicroScan® Dried Gram-Positive MIC/Combo Panels with Synercid are not intended for use with Streptococcus pneumoniae and viridans streptococci.

Woody Dubois

PRESCRIPTION USE X
(PER CFR 801.109)

syn510k.doc.DOC

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).