IDI-MRSA ASSAY

K042357 · Infectio Diagnostic (I.D.I.), Inc. · NQX · Oct 22, 2004 · Microbiology

Device Facts

• Record ID: K042357
• Device Name: IDI-MRSA ASSAY
• Applicant: Infectio Diagnostic (I.D.I.), Inc.
• Product Code: NQX · Microbiology
• Decision Date: Oct 22, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

IDI-MRSA™ assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on the Smart Cycler® instrument with a nasal swab specimen from patients at risk for colonization, utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. IDI-MRSA is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.

Device Story

The IDI-MRSA assay is an in vitro diagnostic test for nasal swab specimens. The process involves specimen collection, concentration, and lysis in a buffer. The lysate is combined with PCR reagents containing MRSA-specific primers targeting the SCCmec insertion site. The Smart Cycler® instrument performs PCR amplification and uses fluorogenic hybridization probes (molecular beacons) to detect amplified DNA. An internal control is included to monitor PCR inhibition and reagent integrity. The instrument automatically handles amplification, fluorescence detection, and signal interpretation. Results are provided to healthcare providers to assist in MRSA colonization screening and infection control protocols. The device is intended for use in laboratory settings.

Clinical Evidence

Performance evaluated via comparison studies between the modified assay and the original formulation. Metrics included analytical sensitivity, specificity, limit of detection, and clinical specimen performance. Results showed >96% agreement with the original formulation, with sensitivity and specificity meeting established claims. Reproducibility met product claims. No new clinical trials were required due to the nature of the modifications.

Technological Characteristics

Nucleic acid amplification test (NAAT) using PCR. Employs fluorogenic target-specific hybridization probes (molecular beacons). Utilizes Smart Cycler® instrument for thermal cycling and fluorescence detection. Includes internal control for inhibition monitoring. Reagents include chemically modified DNA polymerase and primers for SCCmec insertion site. Workflow involves manual specimen preparation followed by automated instrument processing.

Indications for Use

Indicated for qualitative detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) in patients at risk for colonization to aid in infection prevention and control. Not for diagnosing active MRSA infections or guiding treatment.

Regulatory Classification

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.

Predicate Devices

• Infectio Diagnostic Inc. IDI-MRSA™ Assay (K042357)

Submission Summary (Full Text)

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K042357

OCT 2 2 2004

## 510(k) Summary

## Infectio Diagnostic Inc. IDI-MRSA™ assay Special 510(k)

August 28, 2004

| Submitted by: | Infectio Diagnostic Inc.<br>2050, boul. René-Lévesque O, 4e étage<br>Sainte-Foy, Québec<br>Canada<br>G1V 2K8 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Patricia Dionne, PhD. |
| Name of Device: | |
| Trade Name:<br>Common Name: | IDI-MRSATM Assay<br>Test kit for the detection of methicillin-resistant<br>Staphylococcus aureus |
| Product Code: | NQX |
| Classification Name | System, Nucleic Acid Amplification Test, DNA, Methicillin<br>Resistant Staphylococcus aureus, Direct Specimen |
| Predicate Device: | Infectio Diagnostic Inc. IDI-MRSATM Assay |

Device Description:

Intended Use:

IDI-MRSA™ assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on the Smart Cycler® instrument with a nasal swab specimen from patients at risk for colonization, utilizes polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.

IDI-MRSA is not intended to diagnose MRSA infections nor to guide or monitor treatment for Concomitant cultures are necessary only to recover organisms for MRSA infections. epidemiological typing or for further susceptibility testing.

Test Description:

A nasal specimen is collected and transported to the laboratory using the Copan Venturi Transystem®. For testing, the swab is placed in sample preparation buffer. The specimen is concentrated and lysed. An aliquot of the Ivsate is added to PCR reagents which contain the MRSA-specific primers used to amplify the genetic target [a sequence near the insertion site of Staphylococcal Cassette Chromosome mec (SCCmec)], if present. The assay also includes an internal control (IC) used to detect PCR inhibitory specimens and to confirm the integrity of assay reagents in negative specimens. Amplified targets are detected with hybridization probes

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labeled with quenched fluorophores (molecular beacons). The amplification, the detection of fluorescence and the interpretation of signals are done automatically by the Smart Cycler® nuorescence and the interpretainer of eighting 60 to 75 minutes, depending on the number of Institunent. The whole processed takes as a for epidemiological typing or for further Specifichs procosour. This in appropriate culture media can be inoculated during specimen preparation or up to 24 hours after its preparation.

## Substantial Equivalence:

This Special 510(k) is submitted for the following modifications to the Infectio Diagnostic Inc. IDI-MRSA™ assay:

| Modification | Impact of modification |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Development of a 200-tests format<br>(cleared device is a 50-tests format) | Change in the workflow of the preparation of PCR<br>reagents for specimens and controls. Positive and<br>Negative Controls prepared by user. |
| Substitution with chemically modified DNA<br>polymerase complex | Modification of formulation of existing materials and of<br>PCR protocol to optimize reaction conditions for<br>substituted DNA polymerase. |
| Upgrade of software version | Change not pertinent to IDI assay |

Risk analysis performed on the changes did not raise new issues of safety and effectiveness. The parameters listed below were evaluated in comparison studies of the modified assay versus the original formulation. The modified assay met product claims for all parameters

| Parameter | Result |
|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Validation of cut-off | Equivalent to original formulation |
| Verification of amplified products | Estimated number of nucleic acids equivalent to their<br>theoretical sizes |
| Limit of detection | Equivalent to original formulation |
| Analytical sensitivity towards different<br>MREJ polymorphic groups | Equivalent to original formulation |
| Validation of analytical specificity | Equivalent to original formulation |
| Potentially interfering substances | Equivalent to original formulation |
| Performance with clinical specimens | Sensitivity and specificity meet claims;<br>Rate of unresolved specimens equivalent to original<br>formulation;<br>Results agreement with original formulation >96%. |
| Reproducibility | Meets claims |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 2 2004

Infectio Diagnostic (I.D.I.), Inc. c/o Sienna Partners, LLC Ms. Judi Smith Principal P.O. Box 103 Baldwin, MD 21013

k042357 Re:

Trade/Device Name: IDI-MRSATM Assay Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: NQX Dated: October 15, 2004 Received: October 16, 2004

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 encroours) to regists of the Medical Device Amendments, or to conniner of Har to Har to Har 2011 accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). alla Cosmetic Hot (110) that to neview subject to the general controls provisions of the Act. The r ou may, mereleve, mailer of the Act include requirements for annual registration, listing of general controls provisions of tax tice, 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 If your device is clusion (600 a00 ro) als. Existing major regulations affecting your device can may be subject to save adon adon 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 I Tease oc advised that I Dr o ration that your device complies with other requirements of the Act that I DA has made a assod regulations administered by other Federal agencies. You must or any I odetail 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 CI K Part 8077, labornish 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) I ins letter will anow you to ogen mains of substantial equivalence of your device to a legally premitset notification. The PDA mianing of East Minister and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, II you desire specific information advertising of your device, please contact the Office of of questions on the promotion and Safety at [phone]. Also, please note the In Viro Diagliostic De Hood Diarabing by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I bu may oodain other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Saartys

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

Enclosure

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1 - Indications for Use Statement

510(k) Number (if known): K042357

Device Name:___IDI-MRSA™

Indications For Use:

IDI-MRSA™ assay is a qualitative in vitro diagnostic test for the direct detection of nasali colonization by methicillin-resistant Staphylococus aureus (MRSA) to aid in the prevention colonization by memicilinf resistant Staphyrosooooon and the Smart aria Control of MROA in noctoris in noch specimen from patients at risk for colonization, Cycler@ instrument with a nasal onals of the amplification of MRSA DNA and utilizes "polymerase" onain" (roustler)" (rom) - for the detection of the amplified DNA.

IDI-MRSA™ assay is not intended to diagnose MRSA infections nor to guide or monitor IDI-MIKOA - assocy is net internet to concomitant cultures are necessary only to recover troalmons for epidemiological typing or for further susceptibility testing.

Prescription Use _ ٢

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Freddie L. Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) k042357