The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative Gram-Positive cocci. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for a revised QC range of ≥ 0.25 mcg/ml for S. aureus ATCC 29213 with Penicillin.

The Gram-Positive organisms which may be used for Penicillin susceptibility testing in this panel are:

Staphylococci (except penicillinase-producing strains)
Streptococci (group A)

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

Device Description

MicroScan® Dried Gram-Positive MIC/Combo Panels are designed for use in determining quantitative and acceptibility of colonies grown on solid media of rapidly growing aerobic and facultative Gram-Positive cocci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution usceptibility tost that have been diluted in broth and deliyated. Vanous anninorotat agents are diluted in broth to concentrations bridging the range of chilical interest: Tancis are rears are 16-20 hours, the minimum suspension of the organism. After incubation in a non-CO2 incubation the lowest antimi suspension of the organism. After incuration in a non- Organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroScan® Dried Gram-Positive MIC/Combo Panels:

Note: The provided document is a 510(k) summary and FDA clearance letter, which means it describes the device and its intended use, but does not contain the full study report with detailed acceptance criteria, sample sizes, and ground truth information. The information below is extracted from what is available in the provided text.

Description of the Acceptance Criteria and the Study

The submission focuses specifically on a revised Quality Control (QC) range for Penicillin (≥0.25 mcg/ml) for S. aureus ATCC 29213 when used with the MicroScan® Dried Gram-Positive MIC/Combo Panels.

The study aimed to demonstrate that the proposed MicroScan® Dried Gram-Positive MIC/Combo Panel with the revised QC range for Penicillin is substantially equivalent in performance to an NCCLS (National Committee for Clinical Laboratory Standards, now CLSI) frozen Reference.

The general principle of the device is to determine antimicrobial agent susceptibility by miniaturized broth dilution. Antimicrobial agents are diluted in broth, and a suspension of the organism is added. After incubation, the lowest antimicrobial concentration showing inhibition of growth (Minimum Inhibitory Concentration - MIC) is determined.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the specific acceptance criteria for the S. aureus ATCC 29213 with Penicillin QC range are mentioned as:

Acceptance Criterion	Reported Device Performance
*Revised QC range for Penicillin with S. aureus* ATCC 29213**	≥ 0.25 mcg/ml
Performance relative to NCCLS frozen Reference	The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel "demonstrates equivalent performance when compared with an NCCLS frozen Reference."

Specific quantitative acceptance metrics (e.g., essential agreement, category agreement percentages) are not provided in the summary. The statement "demonstrates equivalent performance" is a general claim based on the FDA's guidance document for such devices.

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

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study refers to "assessments data in support of a revised Quality Control (QC) range," implying data collected for this purpose.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. (This type of study typically involves laboratory personnel, but their qualifications are not detailed here).

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. For QC range verification, it's typically a direct comparison, rather than an adjudication process between multiple human readers evaluating a result.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No.
Effect size of human reader improvement: Not applicable, as this is a device for automated/semi-automated susceptibility testing, not a diagnostic imaging aid for human readers.

6. Standalone (Algorithm Only) Performance Study

Was a standalone study done? Yes, inherently. The "demonstrates equivalent performance" claim is for the device (algorithm/system) itself in comparison to a reference standard, without direct human intervention in the MIC determination process after inoculation. The panels can be read visually or with MicroScan instrumentation, but the comparison is directly between the MicroScan panel's result and the reference method.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth was established using an NCCLS frozen Reference method. The document refers to the "FDA DRAFT document 'Guidance on Review Criteria for Assessments data...'" for Antimicrobial Susceptibility Devices, indicating that this reference method is a recognized standard for establishing ground truth in this context.

8. Sample Size for the Training Set

Sample Size for Training Set: Not specified. The document focuses on demonstrating the performance of the pre-developed device with a specific QC range, rather than describing the development/training of the device itself.

9. How Ground Truth for the Training Set Was Established

How Ground Truth Was Established (Training Set): Not applicable/not specified. The document describes a performance evaluation of an existing product with a revised QC range, not the initial development or training phase where a "training set ground truth" would typically be detailed. The device itself (broth dilution method) is a well-established technology; the submission is for a specific product and a revised QC parameter within it.

Summary

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510(k) Summary

0 20162

510(k) Submission Information:

Device Manufacturer:	Dade MicroScan Inc.
Contact name:	Cynthia Van Duker, Regulatory Affairs Manager
Fax:	916-374-3144
Date prepared:	January 16, 2002
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 QC range - Penicillin
Predicate device:	MicroScan Dried Gram Positive MIC/Combo Panels

510(k) Summary:

MicroScan® Dried Gram-Positive MIC/Combo Panels are designed for use in determining quantitative MicroScan® Dried Gram-Positive MIC/Comfoo I and acceptibility of colonies grown on solid media of rapidly growing aerobic and facultative Gram-Positive cocci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution usceptibility tost that have The antimicrobial susceptionity tests are immaturizations of agents are diluted in broth to concentrations been diluted in broth and deliyated. Vanous anninorotat agents and more the minimum bridging the range of chilical interest: Tancis are rears are 16-20 hours, the minimum
suspension of the organism. After incubation in a non-CO2 incubation the lowest antimi suspension of the organism. After incuration in a non- Organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel demonstratially equivalent The proposed MicroScan "Dried Crain-I Ositive NTC/Ochiro Panel as defined in the FDA DRAFT
performance when compared with an NCCLS frozen Reference in Caraceribility Devices" performance when compared with an NCCLS from the research of Antimicrobial Susceptibility Devices ", dated document "Ouldance on Review Chicha for Assessments data in support of a revised Quality Control March 8, 2000. The Premarker (VolthCaton (Srophy) prosens Can and Supply of Gram-Positive MIC/Combo Panel.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 4 2002

Ms. Cynthia Van Duker Regulatory Affairs Manager Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691

Re: K020162

Trade/Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Penicillin (0.03-32, 128 mcg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: LTT, JWY Dated: January 16, 2002 Received: January 17, 2002

Dear Ms. Van Duker:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 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" (21CFR 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-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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INDICATIONS FOR USE STATEMENT

Page_1 of_1_.

510(k) Number (if known): K ہود ہے۔ ہے کہ کے کہ

Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Penicillin (0.03 -32, 128 mcg/ml)

Indications For Use:

This particular submission is for a revised QC range of ≥ 0.25 mcg/ml for S. aureus ATCC 29213 with Penicillin.

The Gram-Positive organisms which may be used for Penicillin susceptibility testing in this panel are:

Staphylococci (except penicillinase-producing strains) Streptococci (group A)

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Freddie L. Poole
	(Division Sign-Off)
	Division of Clinical Laboratory Devices
510(k) Number	K020162

Prescription Use	Over-The-Counter Use
------------------	----------------------

Prescriptic (Per 21 CFR 801.109)

Over The Counter Use: __.

(Optional Format 1-2-96)

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).