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.

Device Description

IDI-MRSA™ assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). 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 lysate 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 an internal of the PC (C is a DNA fragment of 335-bp including a 277-bp assay reagents in hogative optionnel to targets are detected with hybridization probes labeled sequence fluorophores (rnolecular beacons). For the detection of MRSA amplicons, the with quencher beacon contains the fluorophore 5-carboxyfluorescein (amine reactive ester of molocally beader commonly called FAM) at the 5' end and the non-fluorescent quencher carboxy-liderooooin bonneeriy on the opposite end of the oligonucleotide. For the detection moley daboy onlorido (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) ( fluorescein (TET) at the 5' end and the non-fluorescent quencher moiety DABCYL at the 3' end. The test is performed on the Smart Cycler® instrument which monitors simultaneously the fluorescence emitted by each beacon, interprets all data and at the end of the cycling program provides a final result.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance (IDI-MRSA™ Assay)
Ability to detect MRSA-positive specimens (Sensitivity)	92.5% (95% CI: 86.9-96.2%)
Ability to correctly identify MRSA-negative specimens (Specificity)	96.4% (95% CI: 94.6-97.7%)
Consistent performance across different clinical sites	Individual site sensitivities ranged from 86.8% to 100%; specificities ranged from 90.8% to 99.6%
Low rate of unresolved/invalid test results	35 unresolved out of 786 specimens (4.5%); 3 invalid runs out of 89 total runs (3.4%)

Note: The document does not explicitly state "acceptance criteria." The criteria listed above are inferred from the performance metrics presented in the clinical study results and are typical for diagnostic device submissions.

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

Sample Size: 786 nasal swab specimens.
Data Provenance: The data was collected as part of a multi-center study. The specific countries are not mentioned, but the submitting company is based in Canada. The study was prospective in nature, as indicated by the collection of specimens for the study.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set):

The document does not specify the number of individual experts or their qualifications (e.g., radiologists with X years of experience) used to establish the ground truth.
Instead, the ground truth was established using a "reference method" which consisted of a culture-based approach. This method involved:
- Initial analysis with oxacillin screen agar (OxaMSA) after selective growth on mannitol salt agar.
- For specimens negative by OxaMSA, an additional analysis included an enrichment step in trypticase soy broth (OxaTSB) followed by oxacillin screen agar test.
An MRSA-positive specimen was defined as positive by either culture technique, and an MRSA-negative specimen was negative by both.
Further investigation was conducted for discrepant results where IDI-MRSA was positive but culture-negative, which involved "more enhanced culture techniques" (details not provided) and mecA-specific PCR of isolates. This implies expert judgment and advanced laboratory techniques were involved in clarifying these specific cases.

4. Adjudication Method for the Test Set:

The document does not describe a traditional "adjudication method" involving multiple human readers for interpreting the ground truth.
The ground truth was established by a defined laboratory methodology (culture techniques) which inherently serves as a reference standard.
For discrepant results (IDI-MRSA positive, culture negative), "further investigation" was conducted, leading to a reclassification of some specimens. This suggests a form of expert review for these specific cases, but not a full-scale multi-reader adjudication process.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed.
This study evaluates a diagnostic assay (IDI-MRSA™ assay) against a laboratory reference standard (culture method), not the improvement of human readers with AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance study was done. The entire "Clinical Performance" section describes the performance of the IDI-MRSA™ assay on its own, directly comparing its results to the established culture reference method. The reported sensitivity, specificity, positive predictive value, and negative predictive value are all measures of the algorithm's standalone performance.

7. Type of Ground Truth Used:

The primary ground truth used was expert consensus pathology/culture results. This involved a multi-step culture-based reference method (oxacillin screen agar, enrichment in trypticase soy broth, and follow-up mecA-specific PCR for discrepant results).

8. Sample Size for the Training Set:

The document does not explicitly state the sample size for a training set. The study described is a clinical performance study using a test set of 786 specimens.
As this is a molecular diagnostic assay (PCR-based), it is likely that the "training" (development and optimization) would have involved laboratory experiments with characterized strains and clinical samples, but a formal clinical "training set" in the context of machine learning is not applicable or described here.

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

Since a formal "training set" is not explicitly mentioned or applicable in the context of this analytical device, the method for establishing ground truth for such a set is not described.
Presumably, the development of the assay (including primer and probe design) would have been based on known MRSA strains with established genetic characteristics (e.g., presence of SCCmec and mecA gene), and preliminary testing would have involved well-characterized clinical isolates and control samples with confirmed MRSA status via standard microbiological and genetic methods.

Summary

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510(k) Summary

IDI-MRSA™ assay Infectio Diagnostic Inc.

March 17, 2004

Submitted by:	Infectio Diagnostic Inc.2050, boul. René-Lévesque O, 4ª étaqeSainte-Foy, QuébecCanadaG1V 2K8
Contact:	Christian Choquet, PhD.
Name of Device:
Trade Name:Common Name:Product Code:Classification Name	IDI-MRSA™ AssayTest kit for the detection of methicillin-resistantStaphylococcus aureusNOXSystem, Nucleic Acid Amplification Test, DNA, MethicillinResistant Staphylococcus aureus, Direct Specimen
Predicate Device:	PBP2' Latex Agglutination Test (Oxoid)Mueller Hinton Agar with 4% NaCl and 6 μα/ml oxacillin(Remel)
Device Description:

Intended Use:

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 lysate 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

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an internal control (IC) used to detect PCR inhibitory specimens and to confirm the integrity of an internal of the PC (C is a DNA fragment of 335-bp including a 277-bp assay reagents in hogative optionnel to targets are detected with hybridization probes labeled sequence fluorophores (rnolecular beacons). For the detection of MRSA amplicons, the with quencher beacon contains the fluorophore 5-carboxyfluorescein (amine reactive ester of molocally beader commonly called FAM) at the 5' end and the non-fluorescent quencher carboxy-liderooooin bonneeriy on the opposite end of the oligonucleotide. For the detection moley daboy onlorido (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) ( fluorescein (TET) at the 5' end and the non-fluorescent quencher moiety DABCYL at the 3' end.

For the recovery of MRSA for epidemiological typing or for further antibiotic susceptibility testing, appropriate culture media can be inoculated during specimen preparation or up to 24 hours after its preparation.

The amount of fluorescence at any given cycle, or following cycling, depends on the amount of specific amplicon present at that time. The Smart Cycler® instrument monitors simultaneously the fluorescence emitted by each beacon, interprets all data and at the end of the cycling program provides a final result. The operation of the Smart Cycler® instrument is based on the proprietary microprocessor-controlled I-CORE® (Intelligent Cooling/Heating Optical Reaction) Each Smart Cycler® processing block contains 16 independently controlled, module. programmable I-Core® modules, each with one reaction site. Thermally optimized proprietary programmales combined with the design of the I-CORE® modules allow very rapid temperature cycling and rapid amplification. Up to 6 Smart Cycler® processing blocks can be daisy-chained together, allowing simultaneous analysis of 96 discrete samples.

Substantial Equivalence:

The Infectio Diagnostic Inc. IDI-MRSA™ assay has been found to be substantially equivalent to the Oxoid PBP2' Latex Agglutination Test (K011710) and to the culture technique consisting of nrimary isolation on mannitol salt agar followed by the oxacillin screen agar [Mueller Hinton Agar supplemented with 4% NaCl and 6 µg/ml oxacillin (Remel, K850291)) for confirmed isolates of S. aureus.

The IDI-MRSA™ assay is conducted directly on nasal swab specimens; determination of methicillin resistance with the PBP2' Latex Agglutination Test and with the oxacillin screen agar test are performed on isolates identified as Staphylococcus aureus. All assays detect MRSA.

The IDI-MRSA™ assay determines the presence of MRSA through PCR amplification of a sequence located at the insertion site of the Staphylococcal Cassette Chromosome mec (SCCmec) and detection of amplified products with fluorogenic target-specific hybridization; PBP2' Test uses latex agglutination for the detection of the PBP2' protein, one of the gene product of the mecA gene; the culture technique uses phenotypic characteristics of colonies.

With IDI-MRSA™ assay, interpretation of results is done automatically by the Smart Cycler® Instrument; with the PBP2' Latex Agglutination Test and the culture technique, results are interpreted visually by the user.

The reported performance of the Oxoid PBP2' Latex Agglutination Test In comparison (% agreement) with the oxacillin screen agar test on presumptive S. aureus isolates is 100% (232/232) for MRSA and 100% (87/87) for MSSA. Clinical performances of the IDI-MRSA™ assay and of the culture technique in a multi-center study are described below.

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Clinical performance

A multi-center study was conducted on 786 nasal swab specimens collected with the Copan Venturi Transystem. The reference method consisted of an initial analysis with the oxacillia ventuir Transystom. The relective growth on mannitol salt agar. Specimens negative for MRSA screen agar tool an additional analysis consisting of an enrichment step in trypticase soy broth were subjectou to an additional by the oxacillin screen agar test. An MRSA culture-( 1 00) our an in the Revel as a specimen positive for MRSA by either culture technique. An positive specimen was defined as a specimen negative for MRSA by both culture techniques.

Compared to the culture method of reference, the IDI-MRSA™ identified 92.5% of the specimens positive for MRSA by either culture techniques and 96.4% of the specimens negative by both culture techniques (Tables 1 and 2). For the population tested, this results in a negative predictive value of 98.2% and a positive predictive value of 85.4%.

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Table 1. Results obtained with IDI-MRSA™ assay in comparison to the reference method '.

Eight (8) specimens that gave initially unresolved results remained upon retesting with IDI-MRSA™ assay and are not included in the table. All 8 were culture negative.

Fourteen (14) of the 23 culture-negative specimens but IDI-MRSA positive were found to be MRSA culture-positive upon further investigation, resulting in a total of 149 culture-positive and IDI-MRSA positive specimens out of a total of 160 culture positive specimens. For 2 of the culture-positive specimens but IDI-MRSA negative, none of the isolates that exhibited methicillin resistance on oxacillin agar plates could be shown to carry the mecA gene when tested with the mecA-specific PCR assay described by Martineau et al.1

Table 2. Performance of IDI-MRSA™ assay obtained by the investigational sites when compared to the reference method

	Sensitivity(95% CI)	Specificity(95% CI)	No. of unresolvedspecimens	Invalid/ total no.of runs
Site 1	86.8% (n=38)(71.9-95.6%)	99.6% (n=261)(97.9-100%)	6	0/26
Site 2	100% (n=30)(88.4-100%)	98.0% (n=102)(93.1-99.8%)	16	0/21
Site 3	89.3% (n=28)(71.8-97.7%)	90.8% (n=119)(84.1-95.3%)	11	1/15
Site 4	94.0% (n=50)(83.5-98.7%)	94.0% (n=150)(88.9-97.2%)	2	2/27
Total	92.5% (n=146)(86.9-96.2%)	96.4% (n=632)(94.6-97.27%)	35	3/89

Binomial 95% confidence intervals.

All specimens were unresolved due to failed internal controls indicative of inhibition or reagent failure. Twenty-2 seven (27) of the 35 were resplved upon re-testing.

SCCmec typing of MRSA culture-positive s pecimens a ccording to Oliviera and de Lencastre® revealed specimens of types I, II and IV. There were no SCCmec type III specimens isolated

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from the study. However, in a separate study, reference strains and other clinical isolates of all SCCmec types were tested and detected with IDI-MRSA™ assay.

Performances obtained by the investigational sites for IDI-MRSA, and the individual culture techniques as compared to the culture reference method (both culture techniques) are presented in Tables 3 and 4.

method.
Site	MRSA prevalence1	Sensitivity (95% CI)2
		IDI-MRSATM	OxaMSA3	OxaTSB4
Site 1	12.7% (38/300)	86.8%(71.9-95.6%)	81.6%(65.7-92.3%)	ND
Site 2	21.7% (30/138)	100%(88.4-100%)	93.3%(77.9-99.2%)	ND
Site 3	18.9% (28/148)	89.3%(71.8-97.7%)	64.3%(44.1-81.4%)	ND
Site 4	25.0% (50/200)	94.0%(83.5-98.7%)	80.0%(66.3-90.0%)	78.0%(64.0-88.5%)
Total	18.6% (146/786)	92.5%(86.9-96.2%)	80.1%(72.7-86.3%)	ND

Table 3. Results obtained for IDI-MRSA™ assay and each culture screening
technique with :specimens positive for MRSA by the culture reference
method.

Determined from results obtained with the culture reference method (combination of OxaMSA and OxaTSB)

2 Binomial 95% confidence intervals.

3 Oxacillin screen agar test after selective growth on MSA.

4 Oxacillin screen agar test after enrichment in TSB with 6.5% NaCl. Site 4 tested all specimens with both culture techniques while the remaining sites tested only specimens negative with the OxaMSA culture method.

Table 4. Results obtained for IDI-MRSA™ assay and each culture screening technique with specimens negative for MRSA by the culture reference method.

Site	MSSA1	Specificity (95% CI)2
		IDI-MRSATM	OxaMSA3	OxaTSB4
Site 1	73/262	99.6%(97.9-100%)	100%(98.6-100%)	ND
Site 2	25/108	98.0%(93.2-99.8%)	100%(96.4-100%)	ND
Site 3	24/120	90.8%(84.1-95.3%)	100%(96.9-100%)	ND
Site 4	16/150	94.0%(88.9-97.2%)	100%(97.6-100%)	100%(97.6-100%)
Total	138/640	96.4%(94.6-97.7%)	100%(99.4-100%)	ND

Number of MSSA in total MRSA culture-negative population

2 Binomial 95% confidence intervals.

3 Oxacillin screen agar test after selective growth on MSA

4 Oxacillin screen agar test after enrichment in TSB with 6.5% NaCl. Site 4 tested all specimens with both oxamin obroom ager loor answer sites tested only specimens negative with the OxaMSA culture method.

As indicated in Table 4, 138 specimens analyzed with culture techniques were deemed by investigational sites to contain methicillin-sensitive S. aureus . Seven (7) yielded positive results with IDI-MRSA™ assay. Upon further investigation with more enhanced culture techniques, 4 were shown to actually contain MRSA

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

MAR 1 8 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Christian Choquet, Ph.D. VP, Regulatory Affairs and Quality Assurancce Infectio Diagnostic (I.D.I.), Inc. 2050, boul. René-Lévesque O, 4€ étage Sainte-Foy, Québec Canada G1V 2K8

Re: K033415

Trade/Device Name: IDI-MRSA"M Assay Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: NQX Dated: February 16, 2004 Received: February 18, 2004

Dear Dr. Choquet:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave a so row 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 for ass suated in the 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 I ou may a 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 r your device 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 be found in The 2017 - 11:10 and our cerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of actived that i Driver ination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny I edetail 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) remarket notification. The FDA finding of substantial equivalence of your device to a legally presided 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 (301) 594-3084. 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/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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Indications for Use

510(k) Number (if known): __K033415

Device Name: IDI-MRSA™

Indications For 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 colonization by metholim roclotings. The test performed on the Smart Cycler® instrument with a nasal swab specimen from patients at risk for colonization, utilizes Instrument with a hadd ones of other amplification of MRSA DNA and fluorogenic targetspecific hybridization probes for the detection of the amplified DNA.

IDI-MRSA™ assay is not intended to diagnose MRSA infections nor to guide or monitor IDPM On - assay le necessary le necessary only to recover organisms for epidemiological typing or for further susceptibility testing.

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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

KO 33415 510(k)___

Page 1 of

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).