The MicroScan® rapID/S plus" Gram-Negative 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 anaerobic Gram-Negative bacilli (Enterobacteriaceae, glucose non-fermenters, and non-Enterobacteriaceae glucose fermenters. After inoculation, panels are read on the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.

This particular submission is for the antimicrobial Cephalothin on the rapID/S plus " Gram-Negative MIC/Combo Panels.

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

Klebsiella pneumoniae Proteus mirabilis

The MicroScan® rapID/S plus" Gram-Negative Cephalothin is not intended for use with:

Escherichia coli Klebsiella oxytoca Pseudomonas aeruginosa and all Non-Enterobacteriacea

Device Description

MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. The MicroScan® rapID/S plus™ Gran-Negative MIC/Combo Panels are read on the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth to concentrations bridging the range of clinical interest and are presented in micro-titer wells in dried form. rapID/S plus™ panels are inoculated and rehydrated with a standardized suspension of the organism and incubated at 35°C in the WalkAway® SI System or equivalent for 4.5 - 18 hours. The minimum inhibitory concentration (MIC) for the test organism is determined by the lowest antimicrobial concentration showing inhibition of growth.

AI/ML Overview

The provided text describes a 510(k) submission for the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel for antimicrobial susceptibility testing of Cephalothin. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Overall Essential Agreement (compared to NCCLS frozen Reference Panel), as defined in FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000.	Greater than 96% Essential Agreement for Cephalothin.
Instrument reproducibility for Cephalothin with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent.	Acceptable reproducibility and precision.
Quality Control testing for Cephalothin.	Acceptable results.

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

Test Set Sample Size: The text states the external evaluation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains," but it does not provide a specific number for the sample size.
Data Provenance: The text does not explicitly state the country of origin. The study appears to be a prospective evaluation comparing the new device against a reference panel. The "fresh and stock Efficacy isolates and stock Challenge strains" suggest a controlled study design.

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

The information provided does not mention the number of experts used to establish the ground truth or their qualifications. The ground truth for the "Challenge strains" was "Expected Results determined prior to the evaluation," implying a pre-established standard rather than expert consensus on individual cases during the study.

4. Adjudication Method for the Test Set

The text does not describe any adjudication method like 2+1 or 3+1. The performance was compared against an NCCLS frozen Reference Panel and "Expected Results" for challenge strains, suggesting a direct comparison to a predetermined standard rather than a consensus process involving multiple human readers for each test case.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an automated antimicrobial susceptibility testing panel, not an imaging or diagnostic device where human readers would typically interpret results with or without AI assistance. The evaluation focuses on the device's accuracy in determining MIC, not on how it assists human readers.

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

Yes, a standalone study was done. The entire submission describes the performance of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel as a standalone device. The device itself automatically determines the MIC, and its performance was directly compared to a reference standard (NCCLS frozen Reference Panel). The WalkAway® SI System reads the panels, which implies an automated process without human interpretation as the primary output.

7. Type of Ground Truth Used

The ground truth used was primarily a reference standard: the NCCLS frozen Reference Panel for efficacy isolates and "Expected Results" for challenge strains. This implies a pre-defined and validated standard for antimicrobial susceptibility.

8. Sample Size for the Training Set

The text does not mention a training set sample size. This type of device (a microdilution panel read by an automated system) does not typically involve machine learning algorithms that require a distinct "training set" in the same way an AI-based diagnostic image analysis system would. The "training" of the WalkAway® SI System or similar platforms would have been part of its original development and validation, not specific to this 510(k) submission for a new panel formulation.

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

As a training set is not explicitly mentioned or implied for this type of device in the provided text, there is no information on how its ground truth would have been established.

Summary

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

JUN 1 1 2002

Image /page/0/Picture/1 description: The image shows a sequence of characters that appear to be handwritten. The characters are 'K020410'. The characters are written in a rough, slightly distressed style, giving them a textured appearance. The overall impression is that of a handwritten code or identifier.

510(k) Summary

510(k) Submission Information:

Device Manufacturer:	Dade Behring Inc.
Contact name:	Maureen Mende, Group Manager Regulatory Affairs
Fax:	916-374-3144
Date prepared:	February 4, 2002
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panel
Trade Name:	MicroScan® rapID/S plus™ Gram-Negative MIC/Combo panel
Intended Use:	To determine antimicrobial agent susceptibility
510(k) Notification:	Antimicrobials: Cephalothin
Predicate device:	MicroScan Dried Gram Negative MIC/Combo Panels

510(k) Summary:

The proposed MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance 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 MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel Cephalothin.

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 rapID/S p/us™ Gram-Negative Panel by comparing its performance with an NCCLS frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The rapID/S plus™ Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of greater than 96% for Cephalothin when compared with the frozen Reference panel.

Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Cephalothin with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).

Quality Control testing demonstrated acceptable results for Cephalothin.

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

Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a serif font. The text is centered in the image and is the only element present.

Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the seal are three stylized human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.

Food and Drug Administration -2098 Gaither Road Rockville MD 20850

JUN 1 1 2002

Ms. Maureen Mende Group Manager Regulatory Affairs Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691

Re: K020410

Trade/Device Name: MicroScan® RapID/S plus™4 Gram-Negative MIC/Combo Panels with Cephalothin (2-64 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II

Product Code: LON Dated: May 3, 2002 Received: May 7, 2002

Dear Ms. Mende:

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. Ilsting 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 (OS) 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 entifled, "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 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}------------------------------------------------

INDICATIONS FOR USE STATEMENT .

Page 1 of 1 .

510(k) Number (if known): K020410

Device Name: MicroScan® rapID/S plus" Gram-Negative MIC/Combo Panels with Cephalothin (2 - 64 ug/ml)

Indications For Use:

This particular submission is for the antimicrobial Cephalothin on the rapID/S plus " Gram-Negative MIC/Combo Panels.

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

Klebsiella pneumoniae Proteus mirabilis

The MicroScan® rapID/S plus" Gram-Negative Cephalothin is not intended for use with:

Escherichia coli Klebsiella oxytoca Pseudomonas aeruginosa and all Non-Enterobacteriacea

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Per 21 CFR 801.109) OR (Optional Format 1-2-96)

signature

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number	K02 0410
---------------	----------

Regulation Number and Section

§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.

(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”