The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic non-entercoccal streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert.

This particular submission is for the addition of the antimicrobial Vancomycin at concentrations of 0.03 - 16 mcg/ml to the test panel.

The organisms which may be used for Vancomycin susceptibility testing in this panel are; Aerobic non-enterococcal streptococci, including Streptococcus pneumoniae.

Device Description

Microdilution Minimum Inhibitory Concentration (MIC) Panels

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details:

Acceptance Criteria and Device Performance for MicroScan® MICroSTREP plus™ Panel (Vancomycin)

1. Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance (Vancomycin)
Essential Agreement (EA)	Acceptable performance as defined in "Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991)	99%
Reproducibility	Acceptable reproducibility	Acceptable
Quality Control (QC) Testing	Acceptable results	Acceptable

Note: The specific numerical threshold for "acceptable performance" for Essential Agreement is not explicitly stated in the provided text, but the reported 99% was deemed acceptable.

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

Sample Size for Test Set: Not explicitly stated in terms of the number of isolates or tests. The study refers to "fresh and stock Efficacy isolates and stock Challenge strains" for external evaluation.
Data Provenance: Not explicitly stated. The study was an "external evaluation," but the country of origin or whether it was retrospective/prospective is not mentioned.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
Ground Truth Method: The ground truth was established by comparison with an NCCLS frozen Reference Panel. This implies a standardized reference method, but not necessarily human expert consensus for each individual case.

4. Adjudication Method for the Test Set

Adjudication method: Not applicable/not described. The study used an NCCLS frozen Reference Panel as the comparator, which serves as the "truth standard" rather than relying on multiple human readers and an adjudication process.

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

MRMC Study Done: No. This type of study is not relevant for an antimicrobial susceptibility testing device like the MicroScan® MICroSTREP plus™ Panel, which directly measures MIC values and compares them to a reference method, not human interpretation.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Standalone Study Done: Yes. The performance data (99% Essential Agreement, acceptable reproducibility, and QC results) directly represent the standalone performance of the MicroScan® MICroSTREP plus™ Panel in determining Vancomycin susceptibility, as it is a device designed to provide a direct readout.

7. Type of Ground Truth Used

Ground Truth Type: A reference standard, specifically an NCCLS frozen Reference Panel. This panel provides established, standardized minimum inhibitory concentration (MIC) values for comparison.

8. Sample Size for the Training Set

Sample Size for Training Set: Not specified. The document primarily describes the validation (test set) for the new Vancomycin addition, not the original development/training of the panel itself.

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

Ground Truth for Training Set: Not specified. The document focuses on the validation of the Vancomycin component against a reference panel, not the initial development or training ground truth for the core device technology.

Summary

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JAN 1 4 2000

510(k) Summary

510(k) Submission Information:

Device Manufacturer:	Dade MicroScan Inc.
Contact name:	Cynthia Van Duker, Sr. Associate, Regulatory Affairs
Fax:	916-374-3144
Date prepared:	December 13, 1999
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® MICroSTREP plus™ Panel
Intended Use:	To determine bacterial susceptibility to Vancomycin
Indication for Use:	For determining antimicrobic susceptibility of aerobic non-enterococcalstreptococci including Streptococcus pneumoniae
Predicate device:	MicroScan® Streptococcus MIC panel (K963641)

510(k) Summary:

animaly." morobour - mr. 2700 11:27 pm susceptibility of colonies grown on solid media of aerobic nonenterococcal streptococci, including Streptococcus pneumoniae

The proposed MicroScan® MICroSTREP plus™ Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an NCCLS frozen Reference Panel, as defined in the FDA with surproooooan 10 and 11 Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991).

The Premarket Notification (510[k]) presents data in support of the new MicroScan® MICroSTREP plus™ Panel with Vancomycin.

The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed MICroSTREP plus™ The Shellar overline of Cormance with an NCCLS frozen Reference panel. The MICroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of 99% for Vancomycin when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility with Vancomycin.

Quality Control testing demonstrated acceptable results for Vancomycin.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines emanating from its body, representing the department's mission to promote health and well-being.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 4 2000

Ms. Cynthia Van Duker Sr. Associate Regulatory Affairs Dade Microscan, Inc. 1584 Enterprise Boulevard Wcst Sacramento, California 95691

Re: K983953

K765733 Regulatory Class: II Product Code: JWY Dated: December 13, 1999 Received: December 14, 1999

Dear Ms. Van Duker:

We have reviewed your Section 510(k) notification of intent to market the device referenced We have leviewed your becally brothy not(x) not is substantially equivalent (for the indications for above and we have decemined the us as as as a vices marketed in interstate use stated in the encrosure) to regary the enactment date of the Medical Device Amendments, commerce prior to May 20, 1770, the element with the provisions of the Federal or to devices that flave been reciassinou in acay, therefore, market the device, subject to the Food, Drug, alla Cosmette Act. The general controls provisions of the Act include general connous provisions of the Tet. The general 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 If your device is classified (bee aco viect to such additional controls. Existing major (Premations affecting your device can be found in the Code of Federal Regulations, Title 21, regulations anceling your device can ve read determination assumes compliance with the I arts 600 to 675. A substantially of e requirements, as set forth in the Quality System Current Good Manafacturing Pravises: General regulation (21 CFR Part 820) and that, Regulation (QS inspections, the Food and Drug Administration (FDA) will verify such through perfodic Q5 inspections, the F60 Pregulation may result in regulatory action. In assumptions. I andre to comply with the announcements concerning your device in the Federal addition, IDA may publish farmer announcement notification submission does not Register. Ticase note: this response to your sections 531 through 542 of the Act for devices arrect any obligation you hingin liarion Control provisions, or other Federal laws or regulations.

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Page 2

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 Discase Control and Prevention (CDC) at (770)488-7655.

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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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

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Page of

510(k) Number (if known): K 98 3 953 Device Name: MICroSTREP plus " PANEC - VANCOMYCIN

Indications For Use:

The Indications for Use for the test panel are provided below and in the attachment which follows the FDA recommended format.

The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic non-entercoccal streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert.

This particular submission is for the addition of the antimicrobial Vancomycin at concentrations of 0.03 - 16 mcg/ml to the test panel

The organisms which may be used for Vancomycin susceptibility testing in this panel are;

Aerobic non-enterococcal streptococci, including Streptococcus pneumoniae

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois
(Division Sign Off)

(Division Sigff)
Division of Clinical Laboratory Devices
510(k) Number K983953

Prescription Use
(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).