K Number
K060088
Device Name
MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN
Manufacturer
Date Cleared
2006-02-03

(22 days)

Product Code
Regulation Number
866.1645
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MicroScan® Synergies plus™ 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 anaerobic gram-positive staphylococci and enterococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert. This particular submission is for the addition of the antimicrobial Ampicillin, at concentrations of 0.12 to 64 ug/ml for the Long Dilution Sequence and 2 - 8 µg/ml for the Breakpoint Dilution Sequence, to the test panel. The gram-positive organisms which may be used for Ampicillin susceptibility testing in this panel are: Enterococcus species
Device Description
MicroScan® Synergies plus Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (AST) technologies, 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-positive staphylococci and enterococci. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. 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 Synergies plus" Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI System, or equivalent, for 4.5 - 18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.
More Information

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No
The summary describes a standard antimicrobial susceptibility testing panel and its performance compared to a reference method. There is no mention of AI or ML in the device description, intended use, or performance studies.

No.
The device is used for in-vitro diagnostic testing to determine antimicrobial susceptibility, not for treating patients.

Yes

The device is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of bacterial colonies, which is a diagnostic purpose to guide treatment decisions.

No

The device is a physical panel containing dried antimicrobial agents used for susceptibility testing, requiring incubation and reading by instrumentation or visually. It is not solely software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states that the device 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-positive staphylococci and enterococci." This is a diagnostic test performed on biological samples (bacterial colonies) to provide information about a patient's potential response to antimicrobial treatment.
  • Device Description: The description details how the device works by performing miniaturized broth dilution susceptibility tests on bacterial samples. This process is a standard method for in vitro diagnostic testing in microbiology.
  • Performance Studies: The performance studies compare the device's performance to a "frozen Reference panel," which is a common practice for validating the accuracy and reliability of IVD devices. The mention of "Essential Agreement" and comparison to FDA guidance for AST systems further confirms its classification as an IVD.

The device is designed to be used in vitro (outside the body) to analyze biological samples (bacterial colonies) and provide diagnostic information (antimicrobial susceptibility).

N/A

Intended Use / Indications for Use

The MicroScan® Synergies plus™ 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 anaerobic gram-positive staphylococci and enterococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Ampicillin, at concentrations of 0.12 to 64 ug/ml for the Long Dilution Sequence and 2 - 8 µg/ml for the Breakpoint Dilution Sequence, to the test panel.

The gram-positive organisms which may be used for Ampicillin susceptibility testing in this panel are:

Enterococcus species

Product codes (comma separated list FDA assigned to the subject device)

LON, LRG, JWY, LTT

Device Description

MicroScan® Synergies plus Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (AST) technologies, 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-positive staphylococci and enterococci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. 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 Synergies plus" Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI System, or equivalent, for 4.5 - 18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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 Synergies plus™ Gram-Positive Panel by comparing its performance with a frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Efficacy total for the Rapid read method equaled two hundred and ninety three (293) isolates and Challenge total equaled seventy two (72). Results for sixteen (16) isolates, thirteen (13) in Efficacy and three (3) in Challenge, were not reported due to read times >16 hours. Performance claims are based on the Rapid read method. Overnight Instrument and Manual read method(s) Essential Agreement & Categorical Agreement percentages were of equal, or greater, values than the Rapid read method.

The Synergies plus™ Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of >97% for Ampicillin when compared with the frozen Reference panel.

Instrument reproducibility testing demonstrated acceptable reproducibility and precision for Ampicillin, with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent.

Quality Control testing demonstrated acceptable results for Ampicillin.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Essential Agreement >97% for Ampicillin

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels and MicroScan® Dried Gram-Positive Panels

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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§ 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.”

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K060088

510(k) Summary

510(k) Submission Information:

Device Manufacturer:Dade Behring Inc.
Contact name:Robert Eusebio, Regulatory Affairs Manager
Fax:916-374-3144
Date prepared:April 25, 2005
Product Name:Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels
Intended Use:To determine antimicrobial agent susceptibility
510(k) Notification:New antimicrobial - Ampicillin
Predicate device:MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels
and MicroScan® Dried Gram-Positive Panels

510(k) Summary:

MicroScan® Synergies plus Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (AST) technologies, 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-positive staphylococci and enterococci.

Note: Efficacy total for the Rapid read method equaled two hundred and ninety three (293) isolates and Challenge total equaled seventy two (72). Results for sixteen (16) isolates, thirteen (13) in Efficacy and three (3) in Challenge, were not reported due to read times >16 hours. Performance claims are based on the Rapid read method. Overnight Instrument and Manual read method(s) Essential Agreement & Categorical Agreement percentages were of equal, or greater, values than the Rapid read method.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. 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 Synergies plus" Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI System, or equivalent, for 4.5 - 18 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

The proposed MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with a frozen Reference Panel, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003. The Premarket Notification (510[k]) presents data in support of the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel with Ampicillin.

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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 Synergies plus™ Gram-Positive Panel by comparing its performance with a frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The Synergies plus™ Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of >97% for Ampicillin when compared with the frozen Reference panel.

Instrument reproducibility testing demonstrated acceptable reproducibility and precision for Ampicillin, with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent.

Quality Control testing demonstrated acceptable results for Ampicillin.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 3 2006

Mr. Robert Eusebio Regulatory Affairs Manager Dade MicroScan Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972

Re: K060088

Trade/Device Name: MicroScan® Synergies plus ™ Gram-Positive MIC/Combo Panels Ampicillin (0.12 - 64 µg/ml Long Dilution) (2 - 8 µg/ml Breakpoint Dilution) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system. Regulatory Class: Class II Product Code: LON, LRG, JWY, LTT Dated: January 11, 2006 Received: January 12, 2006

Dear Mr. Eusebio:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely yours,

Sale, a Hon

Sally A. Hojvat, M.Sc., Ph.D. I)irector Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Ampicillin (0.12 - 64 ug/ml - Long Dilution) (2 - 8 µg/ml Breakpoint Dilution)

Indications For Use:

The MicroScan® Synergies plus™ 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 anaerobic gram-positive staphylococci and enterococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Ampicillin, at concentrations of 0.12 to 64 ug/ml for the Long Dilution Sequence and 2 - 8 µg/ml for the Breakpoint Dilution Sequence, to the test panel.

The gram-positive organisms which may be used for Ampicillin susceptibility testing in this panel are:

Enterococcus species �

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Liedditi Carlie

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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Am 510k.doc 1/1/2006

A proposa production and consistence and children and children and children and children and consistence and on any

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