DRIED GRAM-POSITIVE MIC/COMBO PANELS

• K Number: K972524
• Device Name: DRIED GRAM-POSITIVE MIC/COMBO PANELS
• Manufacturer: DADE INTL., INC.
• Date Cleared: 1997-09-08 ( 63 days)
• Product Code: JWY
• Regulation Number: 866.1640
• Type: Traditional
• Panel: Microbiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

To determine gram-positive bacterial susceptibility against the antimicrobial agent Sparfloxacin. Organisms with indications for testing* include: Sparfloxacin Gram-Positive Bacteria Staphylococcus aureus

Device Description

Microdilution Minimum Inhibitory Concentration (MIC) Panels

AI/ML Overview

This document describes the acceptance criteria and the study that proves the MicroScan® Dried Gram-Positive MIC/Combo Panels with Sparfloxacin meet those criteria.

1. Table of acceptance criteria and the reported device performance:

   Performance Metric	Acceptance Criteria (implied from predicate)	Reported Device Performance
   Essential Agreement	Substantially equivalent performance compared to NCCLS frozen Sparfloxacin Reference Panels (implied overall >90%)	98.4% overall Essential Agreement
   Reproducibility	Acceptable reproducibility and precision	Acceptable reproducibility and precision across inoculum methods (Turbidity, Prompt) and instruments (autoScan-4, WalkAway Systems)
   Quality Control	Acceptable Quality Control performance	Acceptable Quality Control performance

   Note: The specific numerical acceptance criteria for Essential Agreement were not explicitly stated in the provided text but are implied by the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991), which typically requires high agreement for such devices.

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

   • Sample Size: Not explicitly stated. The study used "fresh and stock Efficacy isolates and stock Challenge strains" for gram-positive external evaluations.
   • Data Provenance: Not explicitly stated, but given this is a US regulatory submission, it is highly likely the data was generated in the US or in compliance with US regulatory standards. The study appears to be prospective in the sense of evaluating the new Sparfloxacin panel against a reference standard in a controlled manner, though the originating isolates (efficacy and challenge strains) could have been collected retrospectively.

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

   • This is not applicable as the "ground truth" was established by a reference method (NCCLS frozen Sparfloxacin Reference Panels), not by individual expert consensus readings of data.

4. Adjudication method for the test set:

   • Not applicable, as the evaluation was a direct comparison to a reference standard, not an expert consensus process.

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:

   • Not applicable. This is a study for an antimicrobial susceptibility device, not an AI-assisted diagnostic tool involving human readers.

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

   • Yes, this was a standalone performance study of the MicroScan® Dried Gram-Positive MIC/Combo Panels compared to a reference method. Human interpretation of the panel results is inherent to its use, but the study itself is evaluating the device's accuracy against a gold standard, not human performance with or without the device.

7. The type of ground truth used:

   • Reference Method: The "ground truth" was established by the NCCLS frozen Sparfloxacin Reference Panels. This is a recognized standard method for determining antimicrobial susceptibility.

8. The sample size for the training set:

   • Not applicable. This device is a diagnostic panel, not a machine learning algorithm that requires a training set in that context. The "development" of the panel would involve internal optimization, but there isn't a "training set" in the sense of AI/ML.

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

   • Not applicable (see point 8).

Summary

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K972524

Dade MicroScan Inc. MicroScan Dried Gram Positive MIC/Combo Panels with Sparfloxacin Premarket Notification K972524 - Amendment 1 August 29, 1997

SEP - 8 1997

510(k) Summary

DADE INTERNATIONA

MicroScan Inc 1584 Enterprise Boulevard West Sacramento, CA 95691 916.372.1900

510(k) Submission Information:

Device Manufacturer:	Dade MicroScan Inc.
Contact name:	Sharolyn Lentsch, Sr. Regulatory Affairs Administrator
Fax:	916-374-3144
Date prepared:	July 3, 1997
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® Dried Gram-Positive MIC/Combo Panels
Intended Use:	To determine antimicrobial agent susceptibility
510(k) Notification:	New antimicrobial - Sparfloxacin
Predicate device:	NCCLS Frozen Sparfloxacin Reference Panels

510(k) Summary:

The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel with Sparfloxacin demonstrated substantially equivalent performance when compared with an NCCLS frozen Sparfloxacin 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, Sparfloxacin, 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 Sparfloxacin panel by comparing its performance with an NCCLS frozen Sparfloxacin Reference panel.

The Dried Gram-Positive Sparfloxacin panel demonstrated acceptable performance with an overall Essential Agreement of 98.4% when compared with the frozen Sparfloxacin Reference panel.

Inoculum and instrument reproducibility testing was conducted; the Gram-Positive Dried Sparfloxacin panel demonstrated acceptable reproducibility and precision, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoScan-4 and WalkAway Systems) was used.

Quality Control performance was acceptable for the Gram-Positive Dried Sparfloxacin panels.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sharolyn Lentsch Senior Regulatory Affairs Administrator Dade International MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, California 95691

SEP - 8 1997

K972524 Re: Trade Name: MicroScan® Dried Gram Positive MIC/Combo Panels New Antimicrobial - Sparfloxacin II Product Code: JWY Regulatory Class: LRG II Dated: July 3, 1997 Received: July 7, 1997

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 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 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirement, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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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Dade MicroScan Inc. MicroScan Dried Gram Positive MIC/Combo Panels with Sparfloxacin Premarket Notification K972524 - Amendment 1 August 29, 1997

1

Intended Use Statement

510(k) No.:	K972524
Device Name:	MicroScan® Dried Gram-Positive MIC/Combo Panels withSparfloxacin (0.015-32 µg/ml)
Indications for Use:	To determine gram-positive bacterial susceptibility against theantimicrobial agent Sparfloxacin. Organisms with indications fortesting* include:
	SparfloxacinGram-Positive BacteriaStaphylococcus aureus

• As taken from the Indications and Usage section of the manufacturers' package insert (Rhone Poulenc Rorer Pharmaceuticals for Sparfloxacin).

Rea Pal

(Division Sign-Off) Division of Clinical 510(k) Number

_ For Prescription Use

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).