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 Cefotaxime at concentrations of 0.015 to 8 mcg/ml to the test panel. The organisms which may be used for Cefotaxime susceptibility testing in this panel are: Streptococcus pyogenes (Group A beta-hemolytic streptococci), Streptococcus agalactiae (Group B streptococci), Streptococcus pneumoniae (formerly Diplococcus 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 (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MicroScan® MICroSTREP plus™ Panel, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Overall Essential Agreement with 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.	98.6% for Cefotaxime
Reproducibility	Acceptable reproducibility and precision with Cefotaxime
Quality Control	Acceptable results for Cefotaxime

Study Details

Sample size used for the test set and the data provenance: The document indicates that "external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, the exact sample size for the test set is not explicitly stated. The data provenance is not specified regarding country of origin, but it is clear that the data relates to a pre-market submission, implying prospective testing for the device's validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document. The ground truth was established by comparing performance to an "NCCLS frozen Reference panel," which implies a standardized method rather than expert consensus on individual cases.
Adjudication method for the test set: Not applicable, as the comparison was against a standardized reference panel (NCCLS frozen Reference panel) rather than individual case adjudication.
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 study evaluates the performance of an in vitro diagnostic device against a reference method, not an AI system assisting human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device operates as a standalone system (microdilution panels read visually). The performance described is its standalone performance against a reference standard. There is no "algorithm only" component in the sense of a software-based AI algorithm. The device, after incubation, is "read visually" as per the package insert.
The type of ground truth used: The ground truth was established by an "NCCLS frozen Reference panel." This is a standardized, recognized reference method for antimicrobial susceptibility testing, which serves as the gold standard for comparison in this context.
The sample size for the training set: This information is not provided. The document focuses on the validation study (test set) of the device against a reference standard. The concept of a "training set" in the context of machine learning or AI is not directly applicable here, as it's a traditional in vitro diagnostic device.
How the ground truth for the training set was established: Not applicable, as no training set (in the machine learning sense) is mentioned or implied for this traditional in vitro diagnostic device. The device's mechanism involves chemical reactions and visual interpretation, not an algorithm that learns from a training set.

Summary

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

6 2002 IIIN

510(k) Summary Information:

Device Manufacturer:	Dade MicroScan Inc.
Contact name:	Cynthia Van Duker, Regulatory Affairs Manager
Fax:	916-374-3144
Date prepared:	April 3, 2002
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® MICroSTREP plus™ Panel
Intended Use:	To determine bacterial susceptibility to Cefotaxime
Indication for Use:	For determining antimicrobic susceptibility with aerobic streptococci, including
	Streptococcus pneumoniae
Predicate device:	MicroScan® Streptococcus MIC Panel (K963641)

510(k) Summarv:

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 (MIC) 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™ Panel with Cefotaxime.

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 98.6% for Cefotaxime when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility and precision with Cefotaxime.

Quality Control testing demonstrated acceptable results for Cefotaxime.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

6 2002 JUN

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

K021111 Re:

Trade/Device Name: MicroScan® MICroSTREP plus™ Panels Microbial agent: Cefotaxime 0.15-8ug/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: LTT Dated: April 3, 2002 Received: April 5, 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.

{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 v 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 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

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

510(k) No.:	K021111(To be assigned by FDA)
Device Name:	MicroScan® MICroSTREP plus™ Panel
Intended Use	To determine bacterial antimicrobial agent susceptibility
Indications for Use:	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 Cefotaxime at concentrations of 0.015 to 8 mcg/ml to the test panel
	The organisms which may be used for Cefotaxime susceptibility testing in this panel are:
	Streptococcus pyogenes (Group A beta-hemolytic streptococci)Streptococcus agalactiae (Group B streptococci)Streptococcus pneumoniae (formerly Diplococcus pneumoniae )

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)	1 -
	(Division Sign-Cit)Division of Clini. In Laboratory Devices

	510(k) Number
Prescription Use_		Over-The-Counter Use
(Per 21 CFR 801.109)	OR
		(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).