To determine bacterial antimicrobial agent susceptibility. The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial Trimethoprim/Sulfamethoxazole at concentrations of 0.06/1.15 to 8/152 mcg/ml to the test panel. The organisms which may be used for Trimethoprim/ Sulfamethoxazole susceptibility testing in this panel are: Streptococcus pneumoniae.

Device Description

The MicroScan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, detailing the acceptance criteria and study information:

Device Performance and Acceptance Criteria

Acceptance Criterion	Reported Device Performance (MICroSTREP plus™ Panel with Trimethoprim/Sulfamethoxazole)
Essential Agreement	100% Essential Agreement with NCCLS frozen Reference Panel
Reproducibility	Acceptable reproducibility and precision
Quality Control	Acceptable results

Note: The specific numerical thresholds for "acceptable" reproducibility and quality control are not provided in the summary, but it's stated that the device met these criteria. Essential Agreement is a common metric for AST devices, comparing the MIC results of the test device to a reference method.

Study Information

1. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: Not explicitly stated as a numerical count of isolates. The document mentions "fresh and stock Efficacy isolates and stock Challenge strains." However, further specifics on the quantity of each type are not provided.
* Data Provenance: The study was an "external evaluation," implying data was collected independently from the device manufacturer. No country of origin is specified, but the use of "NCCLS frozen Reference Panel" suggests a standard recognized in the US (National Committee for Clinical Laboratory Standards, now CLSI). The isolates were a mix of "fresh and stock" and "challenge strains," indicating both recently isolated clinical strains and well-characterized laboratory strains. The study design is implied to be prospective for collecting "fresh... Efficacy isolates" and potentially retrospective for "stock Efficacy isolates and stock Challenge strains" sourced from a frozen bank.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
* Not applicable. The ground truth was established using an NCCLS frozen Reference Panel, not through human experts interpreting results from the device under evaluation.

3. Adjudication Method for the Test Set:
* Not applicable. The comparison was to a reference standard with established results (the NCCLS frozen Reference Panel), not to human interpretations requiring adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
* No, an MRMC study was not done. This study solely evaluated the performance of the device against a reference standard, not the improvement of human readers with AI assistance. The device is a diagnostic panel for susceptibility testing, not an AI-assisted interpretation tool for human readers.

5. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
* Yes, this was a standalone performance study for the device. The device (MicroScan® MICroSTREP plus™ Panel) was evaluated by comparing its visually-read results to an NCCLS frozen Reference Panel. While human observation is involved in reading the MIC, the evaluation focuses on the panel's ability to produce accurate results independently, not on aiding human interpretation with an AI algorithm.

6. Type of Ground Truth Used:
* The ground truth was established by an NCCLS frozen Reference Panel. This panel would have pre-determined and validated Minimum Inhibitory Concentration (MIC) values for the tested antimicrobial agents against specific bacterial strains. This is a highly standardized and accepted method for determining ground truth in antimicrobial susceptibility testing.

7. Sample Size for the Training Set:
* Not applicable. The provided document details a 510(k) submission for a diagnostic panel, which is a physical consumable for laboratory testing. It is not an AI/ML algorithm that requires a training set.

8. How the Ground Truth for the Training Set Was Established:
* Not applicable, as there is no training set for this device.

Summary

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

K020686

510(k) Summary Information:

Device Manufacturer:	Dade MicroScan Inc.
Contact name:	Cynthia Van Duker, Regulatory Affairs Manager
Fax:	916-374-3144
Date prepared:	February 28, 2002
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® MICroSTREP plusTM Panel
Intended Use:	To determine bacterial susceptibility to Trimethoprim/Sulfamethoxazole
Indication for Use	For determining antimicrobic susceptibility with Streptococcus pneumoniae
Predicate device:	MicroScan® Streptococcus MIC Panel (K963641).

510(k) Summary:

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.

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 DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8. 2000.

The Premarket Notification (510|k]) presents data in support of the new MCcoSTREP plus™ with Trimethoprim/Sulfamethoxazole.

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™ Panel by comparing its performance with an NCCLS frozen Reference panel. The MCroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of 100% for Trimethoprim/Sulfamethoxazole when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility and precision with Trimethoprim/ Sulfamethoxazole.

Quality Control testing demonstrated acceptable results for Trimethoprim/Sulfamethoxazole.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping shapes, possibly representing people or services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

APR 3 0 2002

K020686 Re:

K020000
Trade/Device Name: MicroScan® MICroSTREP plus™ Panels with Trimethoprim/Sulfamethoxazole Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: February 28, 2002 Received: March 4, 2002

Dear Ms. Van Duker:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovious your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatery to the enactment date of the Medical Device Amendments, or to conniner of its f in accordance with the provisions of the Federal Food, Drug, de nocs that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may ; iterer exercy misses of the Act include requirements for annual registration, listing of general voltarely provincing 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 rr your device 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 r reaso be actived a determination that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or uny I valuates and states and states including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of K Fut 607); ideeining (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic for the unders) by our by of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{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 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/cdrh/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

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

Indication for Use Statement

510(k) No .:

Device Name:

Intended Use

Indications for Use:

KOZO686 (To be assigned by FDA)

MicroScan® MICroSTREP plus™ Panel

To determine bacterial antimicrobial agent susceptibility

This particular submission is for the addition of the antimicrobial Trimethoprim/Sulfamethoxazole at concentrations of 0.06/1.15 to 8/152 mcg/ml to the test panel

The organisms which may be used for Trimethoprim/ Sulfamethoxazole susceptibility testing in this panel are:

Streptococcus pneumoniae

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

Concurrence of CDRH, Office of Device Exaluation

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number K02 0676

Over-The-Counter Use

(Optional Format 1-2-96)

Over-The-Counter C

Prescription Use
(Per 21 CFR 801.109)

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).