The BD MAX™ StaphSR assay performed on the BD MAX™ System is an automated qualitative in vitro diagnostic test for the direct detection and differentiation of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. The test utilizes realtime polymerase chain reaction (PCR) for the amplification of MRSA/SA DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. The BD MAX™ StaphSR assay is intended to aid in the prevention and control of MRSA and SA infections in healthcare settings. It is not intended to diagnose MRSA or SA infections nor guide or monitor treatment for MRSA/SA infections. A negative result does not preclude nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Device Description

The BD MAX™ System and the BD MAX™ StaphSR assay are comprised of an instrument with associated hardware and accessories, disposable microfluidic cartridges, master mixes, unitized reagent strips, extraction reagents, and sample buffer tubes. The instrument automates sample preparation including target lysis, DNA extraction and concentration, reagent rehydration, and target nucleic acid amplification and detection using real-time PCR. The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances. The BD MAX™ System software automatically interprets test results. A test result may be called as [SA NEG MRSA NEG (negative)], [SA POS, MRSA POS (MRSA positive)], [SA POS, MRSA NEG (SA positive)] or [SA UNR, MRSA UNR (Unresolved)] based on the amplification status of the target and of the Sample Processing Control. IND (Indeterminate) or INC (Incomplete) results are due to BD MAX™ System failure.

AI/ML Overview

The BD MAX™ StaphSR assay is an automated qualitative in vitro diagnostic test for the direct detection and differentiation of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs. The performance of the device was evaluated in both analytical and clinical studies.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BD MAX™ StaphSR assay are primarily based on achieving certain levels of sensitivity and specificity when compared against a reference method (direct culture complemented by enriched culture). The document details the reported performance for MRSA and SA detection.

Acceptance Criteria and Reported Performance for BD MAX™ StaphSR Assay

Metric	Acceptance Criteria (Implied)	Reported Performance (Overall) - Compared to Reference Method
MRSA Detection	High sensitivity and specificity	Sensitivity: 93.1% (95% CI: 88.1%, 96.1%)
		Specificity: 97.5% (95% CI: 96.8%, 98.1%)
		Positive Predictive Value (PPV): 73.2% (95% CI: 67.8%, 78.3%)
		Negative Predictive Value (NPV): 99.5% (95% CI: 99.1%, 99.7%)
SA Detection	High sensitivity and specificity	Sensitivity: 92.0% (95% CI: 89.7%, 93.9%)
		Specificity: 93.1% (95% CI: 91.8%, 94.2%)
		Positive Predictive Value (PPV): 83.4% (95% CI: 81.9%, 85.8%)
		Negative Predictive Value (NPV): 96.8% (95% CI: 96.0%, 97.6%)
Unresolved Rate	Low unresolved rate	Initial Unresolved Rate: 0.6% (15/2399)
		Unresolved Rate after Repeat: 0.04% (1/2399)
Inclusivity	Detection of various MRSA and MSSA strains/genotypes at low LoD	Detected 11 MREJ genotypes, 5 SCCmec types, various PFGE types, VRSA, VISA, and 51 MSSA strains (at 2-3 x LoD).
Specificity	No cross-reactivity with non-target organisms	No interference from 57 non-staphylococcal species, 45 CoNS/CoPS strains, 50 MSSA strains, and 17 viruses.
Interference	No significant interference from common nasal substances	No reportable interference from 29 substances/microorganisms, except for Tobramycin at a high concentration.
Carryover/Cross-Contamination	Low risk of carryover/cross-contamination	3 false positive results (1.5%) out of 203 expected negative samples due to carry-over.
Reproducibility	Consistent results across sites and lots	Site-to-Site & Lot-to-Lot agreement: 100% for MP MRSA & TN, 96.7-97.8% for LP MRSA & LP MSSA.

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

For the clinical performance studies, a total of 2451 specimens were enrolled. After excluding non-compliant specimens, 2354 specimen results were used to determine the clinical performance against the Reference Method, and 2393 specimen results were used for comparison against Direct Culture.

The data provenance for the clinical study is prospective, collected from three geographically diverse investigational centers. The specific countries of origin for these centers are not explicitly stated.

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

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., radiologist with X years of experience). However, the ground truth was established using laboratory methods rather than expert interpretation of images or clinical assessments.

4. Adjudication Method for the Test Set

The adjudication method for the clinical test set involved a Comparative Reference Method consisting of direct culture complemented by enriched culture.

For specimens negative for MRSA or SA by direct culture, enriched culture analysis was performed.
Presumptive S. aureus colonies on chromogenic medium were subcultured onto Blood Agar (BA) for identification confirmation with an agglutination test.
Methicillin resistance was confirmed by Cefoxitin disk (30 µg) diffusion susceptibility testing.
Enrichment in Trypticase Soy Broth with 6.5% NaCl was carried out if MRSA or SA was not confirmed by initial direct culture.
Turbid TSB 6.5% NaCl broth was used to inoculate additional chromogenic medium and BA plates, and MRSA confirmation followed the same procedure.
Further investigation was performed on specimens with discordant results between the Reference Method and the BD MAX™ StaphSR assay. For MRSA, 12 of 54 false positive and 5 of 11 false negative BD MAX™ StaphSR specimens were re-evaluated by the Reference Method. For SA, 28 of 118 false positive and 23 of 52 false negative BD MAX™ StaphSR specimens were re-evaluated by the Reference Method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable as the BD MAX™ StaphSR assay is an automated in vitro diagnostic test (molecular assay) for direct detection of DNA. It does not involve "human readers" or AI assistance in the interpretation of results in the context of an MRMC study. The device provides an automated interpretation of results.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The BD MAX™ StaphSR assay is an automated instrument-based test that directly provides a qualitative result ([SA NEG MRSA NEG], [SA POS, MRSA POS], [SA POS, MRSA NEG], or [SA UNR, MRSA UNR]). The clinical performance data presented in Tables 10-17 directly reflect the standalone performance of the assay compared to the reference microbiological methods.

7. The Type of Ground Truth Used

The ground truth used for both the analytical and clinical studies was based on microbiological culture methods:

Direct culture complemented by enriched culture for clinical performance evaluation.
Cultured bacterial suspensions and well-characterized clinical isolates for analytical studies (e.g., LoD, inclusivity, specificity, competitive inhibitory effect).

8. The Sample Size for the Training Set

The document describes premarket studies for a diagnostic device. For such devices, there isn't typically a "training set" in the machine learning sense. Instead, development and optimization are performed using various analytical samples and potentially some initial clinical samples, followed by a robust validation (clinical performance) on an independent set. The details of any specific samples used for internal development or optimization (analogous to a training set) are not provided in this 510(k) summary. The provided sample sizes relate to the analytical validation and the final clinical validation dataset.

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

Given that this is a molecular diagnostic assay and not an AI/ML-based image interpretation product, the concept of a "training set" with ground truth established in that context is not directly applicable. If one were to consider the samples used for assay development and optimization as a "training set," their ground truth would have been established through known bacterial cultures (characterized strains, quantified suspensions) and potentially well-characterized clinical isolates with confirmed microbiological status (e.g., through traditional culture, biochemical tests, and susceptibility testing). However, specific details of such "pre-validation" ground truth establishment are not provided in this regulatory summary.

Summary

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K132822.

510(k) Summary

November 19, 2013

BD Diagnostics BD MAX™ StaphSR

Submitted by:

GeneOhm Sciences Canada Inc. (BD Diagnostics) 2555 Boul. Parc-Technologique Quebec (Quebec), Canada G1P 4S5

Contact:

Device:

NOV 2 6 2013

510(k) Number:

Trade Name:

BD MAX™ StaphSR

K132822

Patricia Dionne, Ph.D.

Common Name:

Type of Test:

Staphylococcus aureus and Methicillin-resistant Staphylococcus aureus Qualitative Nucleic Acid Amplification Test from nasal swab specimens

Staphylococcus aureus and Methicillin-resistant

Staphylococcus aureus detection assay

Classification:

Antimicrobial susceptibility test powder Requlation Name:

866.1640 Requiation Number:

Product Code: NQX: OOI

Microbiology (83) Panel:

Predicate Devices: BD MAX™ MRSA and BD GeneOhm™ StaphSR Assay

Predicate 510(k) Numbers: K120138 and K071026

Intended Use:

The BD MAX™ StaphSR assay performed on the BD MAX™ System is an automated qualitative in vitro diagnostic test for the direct detection and differentiation of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. The test utilizes realtime polymerase chain reaction (PCR) for the amplification of MRSA/SA DNA and fluorogenic tarqet-specific hybridization probes for the detection of the amplified DNA. The BD MAX™ StaphSR assay is intended to aid in the prevention and control of MRSA and SA infections in healthcare settings. It is not intended to diagnose MRSA or SA infections nor guide or monitor treatment for MRSA/SA infections. A negative result does

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not preclude nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Indication for Use:

The BD MAX™ StaphSR assay performed on the BD MAX™ System is an automated qualitative in vitro diagnostic test for the direct detection and differentiation of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. The test utilizes realtime polymerase chain reaction (PCR) for the amplification of MRSA/SA DNA and fluorogenic target-specific hybridization probes for the amplified DNA. The BD MAX™ StaphSR assay is intended to aid in the prevention and control of MRSA and SA infections in healthcare settings. It is not intended to diagnose MRSA or SA infections nor guide or monitor treatment for MRSA/SA infections. A negative result does not preclude nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Special Conditions for Use Statement:

For prescription use

Special Instrument Requirements:

The BD MAX™ System

Device Description:

Test Principle:

The BD MAX™ StaphSR assay performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct, qualitative detection and differentiation of the Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization.

A nasal specimen is collected and transported to the laboratory using the recommended swab. The swab is placed in a BD MAX™ StaphSR Sample Buffer Tube. The Sample

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Buffer Tube is closed with a septum cap and vortexed. A worklist is created and the Sample Buffer Tube, the BD MAX™ StaphSR unitized reagent strip and the BD MAX™ PCR Cartridge are loaded onto the BD MAX™ System.

Following enzymatic cell lysis, the released nucleic acids are captured on magnetic i beads. The beads, with the bound nucleic acids, are washed using Wash Buffer and the nucleic acids are eluted by heat in Elution Buffer. Eluted DNA is neutralized using Neutralization Buffer and transferred to a Master Mix to rehydrate PCR reagents. After reconstitution, the BD MAX™ System dispenses a fixed volume of PCR-ready solution containing extracted nucleic acids into the BD MAX™ PCR Cartridge. Microvalves in the BD MAX™ PCR Cartridge are sealed by the system prior to initiating PCR to contain the amplification mixture, thus preventing evaporation and contamination.

The amplified DNA targets are detected using hydrolysis (TagMan®) probes labeled at one end with a fluorescent reporter dye (fluorophore) and at the other end with a quencher moiety. Probes labeled with different fluorophores are used to detect a specific amplicon in the SCCmec right-extremity junction (MREJ), the genes for methicillin resistance mecA and mecC, the nuc gene encoding a thermostable nuclease of S. aureus and SPC amplicons in four different optical channels of the BD MAX™ System: MREJ amplicons are detected in the FAM channel, mecA and mecC amplicons are detected in the ROX channel, nuc amplicons are detected in the VIC channel and SPC amplicons are detected in the Cy5.5 channel. When the probes are in their native state, the fluorescence of the fluorophore is quenched due to its proximity to the quencher. However, in the presence of target DNA, the probes hybridize to their complementary sequences and are hydrolyzed by the 5-3' exonuclease activity of the DNA polymerase as it synthesizes the nascent strand along the DNA template. As a result, the fluorophores are separated from the quencher molecules and fluorescence is emitted. The amount of fluorescence detected in the four optical channels used for the BD MAX™ StaphSR assay is directly proportional to the quantity of the corresponding probe that is hydrolyzed. The BD MAX™ System measures these signals at the end of each amplification cycle, and interprets the data to provide a result.

Substantial Equivalence:

Table 1 shows the similarities and differences between the BD MAX™ StaphSR assay and the predicate devices.

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	DEVICE	PREDICATE
ITEM	BD MAX™ StaphSR(K132822)	BD GeneOhm StaphSRAssay (K071026)	BD MAX MRSA Assay(K120138)
Intended Use	The BD MAX™ StaphSR assayperformed on the BD MAX ™System is an automatedqualitative in vitro diagnostic testfor the direct detection anddifferentiation of Staphylococcusaureus (SA) and methicillin-resistant Staphylococcus aureus(MRSA) DNA from nasal swabsin patients at risk for nasalcolonization. The test utilizesreal-time polymerase chainreaction (PCR) for theamplification of MRSA/SA DNAand fluorogenic target-specifichybridization probes for thedetection of the amplified DNA.The BD MAX™ StaphSR assayis intended to aid in theprevention and control of MRSAand SA infections in healthcaresettings. It is not intended todiagnose MRSA or SA infectionsnor guide or monitor treatmentfor MRSA/SA infections. Anegative result does notpreclude nasal colonization.Concomitant cultures arenecessary to recover organismsfor epidemiological typing or forfurther susceptibility testing.	The BD GeneOhm™ StaphSRAssay is a qualitative in vitrodiagnostic test for the rapiddetection of Staphylococcusaureus (SA) and methicillin-resistant Staphylococcusaureus (MRSA) directly frompositive blood culture. Theassay utilizes polymerasechain reaction (PCR) for theamplification of specific targetsand fluorogenic target-specifichybridization probes for thereal-time detection of theamplified DNA. The assay isperformed on Gram positivecocci, identified by Gram stain,from positive blood cultures.The BD GeneOhm™ StaphSRAssay is not intended tomonitor treatment forMRSA/SA infections.Subculturing of positive bloodcultures is necessary forfurther susceptibility testing.	The BD MAX™ MRSA Assayperformed on the BD MAX ™System is an automatedqualitative in vitro diagnostictest for the direct detection ofMethicillin-resistantStaphylococcus aureus (MRSA)DNA from nasal swabs inpatients at risk for nasalcolonization. The test utilizesreal-time polymerase chainreaction (PCR) for theamplification of MRSA DNA andfluorogenic target-specifichybridization probes for thedetection of the amplified DNA.The BD MAX™ MRSA Assay isintended to aid in the preventionand control of MRSA infectionsin healthcare settings. It is notintended to diagnose, guide ormonitor MRSA infections. Anegative result does notpreclude nasal colonization.Concomitant cultures arenecessary to recover organismsfor epidemiological typing or forfurther susceptibility testing.
Specimen type	Nasal swabs	Positive blood culture	Nasal swabs
Assay Format	Amplification: PCRDetection: Fluorogenic target-specific hybridization	Same	Same
Mode of Detectionfor MethicillinResistance inS.aureus	Presence of SCCmec cassetteat orfX junction and mecA ormecC genes	Presence of SCCmec cassetteat orfX junction (specific to S.aureus)	Presence of SCCmec cassetteat orfX junction (specific to S.aureus)
Mode of Detectionfor SA	Presence of nuc gene specificfor SA	Same	Not detected
Interpretation ofTest Results	Automated (Diagnostic softwareof BD MAX™ System)	Automated (Diagnosticsoftware of SmartCycler®System)	Automated (Diagnostic softwareof BD MAX™ System)
Analysis Platform	BD MAX™ System	SmartCycler® System	BD MAX™ System
PCR SamplePreparation	Automated by the BD MAX TMSystem	Manual	Automated by the BD MAX TMSystem
Detection Probes	TaqMan® Probe	Molecular Beacon Probe	TaqMan® Probe
ITEM	DEVICE	PREDICATE
	BD MAX™ StaphSR(K132822)	BD GeneOhm StaphSRAssay (K071026)	BD MAX MRSA Assay(K120138)
Assay Controls	Specimen Processing Control(SPC)	Positive PCR control (DNAfrom S.aureus ATCC 43300).Negative control (DNA fromS.epidermidis ATCC 14990).Internal Control	Specimen Processing Control(SPC)

Table 1: Substantial Equivalence Information

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Analytical Performance:

Precision

Within-laboratory precision was evaluated for the BD MAX™ StaphSR assay at one (1) site. The Precision panel consisted of 4 sample categories near the LoD. Each specimen contained simulated nasal matrix. MRSA and MSSA strains were tested as follows:

Moderate Positive (MP) MRSA (MREJ Type ii): ≥ 2 and ≤ 5 x LoD .
Low Positive (LP) MRSA (MREJ Type ii): ≥ 1 and < 2 x LoD .
Low Positive (LP) MRSA (MREJ Type vii): ≥ 1 and < 2 x LoD .
Low Positive (LP) MSSA: ≥ 1 and < 2 x LoD .
High Negative (HN) MRSA (MREJ Type ii): < 1 x LoD .
High Negative (HN) MSSA: < 1 x LoD .
True negative (TN): Negative specimens (no target) .

Testing was performed in duplicate, over 12 days, with 2 runs per day, by 2 different technologists. Precision study results for TN, MP, LP, and HN MRSA samples demonstrated 100%, 100%, 97.9%, and 27.1% agreement, respectively. Precision study results for LP and HN MSSA samples demonstrated 100%, and 56.2% agreement, respectively.

Reproducibility

The reproducibility study was performed using the same sample categories as defined above for the Precision Study.

Samples in each category were tested in triplicate, on 5 distinct days, wherein each day 2 panels were tested by 2 different technologists, at 3 clinical sites using 1 lot of reagents (Site-to-Site). One (1) of these clinical sites participated in an extended study where 2 additional lots of reagents were tested (Lot-to-Lot). Results are shown for each sample category with the data from both MRSA strains pooled and MSSA strains.

For Site-to-Site Reproducibility, the overall percent agreement was 100% for MRSA MP and TN categories; 96.7% and 97.8% for MRSA LP and MSSA LP, respectively; and 36.7% and 30.0% for MRSA HN and MSSA HN, respectively (Table 2).

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	SITE
Category	Site 1		Site 2		Site 3		Overall Percent
	PercentAgreement	Count	PercentAgreement	Count	PercentAgreement	Count		Agreement
HN1 MSSA	16.7%	5/30	23.3%	7/30	50.0%	15/30	30.0%	(21.5%, 40.1%)2
HN MRSA	40.0%	12/30	26.7%	8/30	43.3%	13/30	36.7%	(27.4%, 47.0%)
LP MSSA	96.7%	29/30	100.0%	30/30	96.7%	29/30	97.8%	(92.3%, 99.4%)
LP MRSA	95.0%	57/60	98.3%	રુજીકા	96.7%	28160	96.7%	(92.9%, 98.5%)
MP MRSA	100.0%	30/30	100.0%	30/30	100.0%	30/30	100.0%	(95.9%, 100.0%)
TN	100.0%	30/30	100.0%	30/30	100.0%	30/30	100.0%	(95.9%, 100.0%)

Table 2. Site-To-Site Reproducibility Study Results Using One Lot of the BD MAX™ StaphSR Assay

1Percent Agreement correlates to the percent of negative results.

2Confidence Interval

For Lot-to-Lot Reproducibility, the overall percent agreement was 100% for MRSA MP and TN; 96.7% for MRSA LP and MSSA LP; 40.0% and 44.4% for MRSA HN and MSSA HN, respectively (Table 3).

Table 3. Lot-To-Lot Reproducibility Study Results using Three Lots of the BD MAX™ StaphSR Assay

	LOT
Category	Lot 1		Lot 2		Lot 3		Overall Percent
	PercentAgreement	Count	PercentAgreement	Count	PercentAgreement	Count	Agreement
HN 1 MSSA	50.0%	15/30	36.7%	11/30	46.7%	14/30	44.4%	(34.6%, 54.7%)2
HN MRSA	43.3%	13/30	43.3%	13/30	33.3%	10/30	40.0%	(30.5%, 50.3%)
LP MSSA	96.7%	29/30	93.3%	28/30	100.0%	30/30	96.7%	(90.7%, 98.9%)
LP MRSA	96.7%	58/60	96.7%	58/60	96.7%	58/60	96.7%	(92.9%, 98.5%)
MP MRSA	100.0%	30/30	100.0%	30/30	100.0%	30/30	100.0%	(95.9%, 100.0%)
TN	100.0%	30/30	100.0%	30/30	100.0%	30/30	100.0%	(95.9%, 100.0%)

1Percent Agreement correlates to the percent of negative results. 2Confidence Interval

Site-to-Site and Lot-to-Lot Reproducibility performance was acceptable for the LP, MP, and TN sample categories. No specific acceptance criteria was defined for the high negative sample category.

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Second Derivative Peak Abscissa (SDPA), an underlying numerical value used to determine a final assay result, was selected as an additional means of assessing assay reproducibility. Overall mean SDPA values with variance components (SD and %CV) are shown in Table 4.

		Site-to-Site			Lot-to-Lot
		HN MRSA	LP MRSA	MP MRSA	HN MRSA	LP MRSA	MP MRSA
MREJ1 (MREJtypes pooled,FAM Channel)	N	33	174	90	35	174	90
	Mean	33.5	31.1	30.7	33.4	31.0	30.8
	SD	0.72	1.05	0.71	0.72	0.94	0.37
	%CV	2.2%	3.4%	2.3%	2.2%	3.0%	1.2%
mecA or mecC 2(MREJ typespooled, ROXChannel)	N	33	174	90	35	174	90
	Mean	35.1	31.8	31.1	35.0	31.7	31.1
	SD	1.16	1.42	0.78	1.15	1.36	0.54
	%CV	3.3%	4.5%	2.5%	3.3%	4.3%	1.7%
		HN MREJType ii	HN MSSA	LP MSSA	HN MREJType ii	HN MSSA	LP MSSA
nuc 3(VIC Channel)	N	24	63	88	19	50	87
	Mean	34.9	34.8	32.0	35.2	34.8	32.0
	SD	1.78	1.69	1.12	1.85	1.57	0.78
	%CV	5.1%	4.9%	3.5%	5.2%	4.5%	2.4%
		HN MREJType ii	HN MSSA	TN	HN MREJType ii	HN MSSA	TN
SPC4(Cy5.5 Channel)	N	33	27	90	36	40	90
	Mean	30.0	30.3	30.2	29.9	30.0	30.0
	SD	0.79	0.68	0.63	0.49	0.43	0.45
	%CV	2.6%	2.2%	2.1%	1.7%	1.4%	1.5%

Table 4. Site-to-Site and Lot-to-Lot Reproducibility Study Underlying Numerical SDPA
Overall Results

'Values shown are those obtained for the MREJ target in the samples that gave a SA POS, MRSA POS result

2Values shown are those obtained for the mech or mec target in the samples that gave a SA POS, MRSA POS result

3Values shown are those obtained for the nuc target in the samples that gave a SA POS, MRSA NEG result 4 Calculated for the Specimen Processing Control of the samples that gave a SA NEG, MRSA NEG result

Sample Storage

Specimens can be stored at25 ±2°C for a maximum of 48 hours or at 2-8 °C for a maximum of 120 hours (5 days) before testing. In case of repeat testing from the Sample Buffer Tube, the following storage conditions apply:

within 36 hours of the steps covered in the Specimen Preparation section of the . package insert, when stored at 25 ±2℃ or
up to 120h (5 days) after the end of the initial run when stored at 2-8°C. .

Controls

External Control materials are not provided by BD. Various types of External Controls are recommended to allow the user to select the most appropriate for their laboratory quality control program:

Commercially available control materials [e.g. a reference MRSA strain (ATCC -43300), and Methicillin-susceptible Staphylococcus aureus strain (e.g. ATCC 29213) can be used as positive controls. Staphylococcus epidermidis strain (e.g. ATCC 12228) can be used as negative control.].

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Previously characterized specimens known to be positive or negative for S. aureus or MRSA.
The assay includes a Sample Processing Control (SPC) that is present in the Extraction Tube. The SPC monitors DNA extraction steps, thermal cycling steps, reagent integrity and the presence of inhibitory substances.

Analytical Sensitivity

The analytical sensitivity (Limit of Detection or LoD) for the BD MAX™ StaphSR assay was determined as follows: positive specimens were prepared by soaking swabs in a wide range of MRSA or MSSA bacterial suspensions prepared and quantified from cultures. The tested strains included 11 MRSA strains representing 11 MREJ genotypes (i, ii, iii, iv, v, vi, vii, ix, xiii, xiv and xxi) corresponding to 5 SCCmec types (1, II, III, IV and XI) as well as 2 MSSA strains. The swabs were then eluted in simulated nasal matrix. Each MRSA and MSSA strain was tested in replicates of 24 per concentration by 2 different operators using 3 different production lots of the BD MAX™ StaphSR assay. Analytical sensitivity (LoD), defined as the lowest concentration at which at least 95% of all replicates tested positive, ranged from 64 to 343 CFU/swab (Table 5) for the detection of MRSA strains and from 174 to 211 CFU/swab (Table 6) for the detection of MSSA strains.

MRSA Strain	MREJ Genotype	SCCmec type	LoD Concentration[CFU/swab (95% CI²)]
1	Type i	I	84 (49, 142)
2	Type ii	II	103 (64, 167)
3	Type iii	III	160 (93, 278)
4	Type iv	III	68 (42, 109)
5	Type v	IV	128 (73, 225)
6	Type vi	ND³	343 (186, 632)
7	Type vii	II	219 (110, 439)
8	Type ix	ND³	144 (82, 255)
9	Type xiii	ND³	64 (36, 114)
10	Type xiv	ND³	78 (48, 127)
11	Type xxi	XI	112 (64, 197)

Table 5: Limit of Detection of MRSA Genotypes by the BD MAX™ StaphSR Assay

SCCmec type does not correlate to the MREJ type as these are two different typing methods. CI: Confidence Intervals

ND = not determined

mecc-containing MRSA strains (Also known as mecAuga25; strain)

		Table 6: Limit of Detection of MSSA by the
		BD MAX™ StaphSR Assay

MSSA Strain	LoD Concentration [CFU/swab(95% CI)]
1	174 (89, 341)
2	211 (105, 428)

1Cl: Confidence Intervals

Analytical Inclusivity

An analytical inclusivity study was performed using a variety of MRSA and MSSA strains, taking into account geographic origin, MREJ genotype (wild type and mutant), SCCmec type. Pulsed-Field Gel Electrophoresis (PFGE) type, temporal diversity and susceptibility pattern. Seventy-seven (77) MRSA strains from 27 countries (see Table 7) and 51 MSSA strains from 16 countries were tested in this study, including strains

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from public collections and from well-characterized clinical isolates, including Vancomycin-Resistant Staphylococcus aureus (VRSA) and Vancomycin Intermediate Staphylococcus aureus (VISA) strains.

The BD MAX™ StaphSR assay detected MREJ types i, ii, iii, iv, v, vi, vii, ix, xiii, xiv and xxi when tested at low bacterial load (2-3 x LoD). The BD MAX™ StaphSR assay detected MRSA SCCmec types 1, II, III, IV, V, VI, VII, VIII, VIII and XI as well as MRSA PFGE types USA 100 to 800, 1000 and 1100 at 2-3 x LoD. All MRSA strains displaying additional resistance to vancomycin (VRSA and VISA) were also detected. The BD MAX™ StaphSR assay detected all 51 MSSA strains tested including mecA empty cassette variants.

Collection	Reference,Number	MREJType	SCCmectyping / PFGEtype
ATCC	ATCC BAA-1770	iii	USA1000
	ATCC BAA-421	ii	VI
	ATCC BAA-38	i	I
	ATCC BAA-41	ii	II
	ATCC BAA-39	iii	III
	ATCC BAA-40	iv	III
	ATCC 43300	ii	II
	ATCC 33592	iv	III
Harmonycollection ofEuropeanepidemicMRSA	62305	ii mut36	IV
	97S99	ii mut45	IV
	3717	iii	III
	9805-01937	iii mut45	ND
LSPQ	ID-61882	iii	III / CMRSA-3
	ID-61880	vii	II / CMRSA-1
NARSA	NRS383	ii	II / USA200
	NRS385	ii	IV / USA500
	NRS715	ii	II/USA600
	NRS386	ii	IV / USA700
	NRS686	i	IV/IBERIAN
	NRS234	ii	II
	VRS53	ii	ND
	NRS14	ii	II
	NRS44	ii	II
	VRS23	ii	ND
	VRS41,3	ii	ND
	NRS382	ii	II / USA100
	NRS384	ii	IV / USA300
	NRS387	ii	IV / USA800
	NRS484	ii	IV / USA1100
	NRS645	ii	IV/IBERIAN
	NRS123	ii mut36	IV / USA400
NA	NA	ii	II / USA 100
	NA	iii	II / USA 100
	5599	ii	II / USA100
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Collection	Reference		SCCmedvoing / Ptype
	7909	li	IV / USA300
	7916	ii	IV / USA300
	7917	ii	IV / USA300
	7921	li	IV / USA300
	7922	li	IV / USA300
	7913	ii mut36	IV / USA400
	NA	ll	IV / USA 800
	1555	XXI	ND
	MAH 305	xxi	ND
	CCRI-11840	i	VIII ·
	JCSC6082	iii	VII
	92	xili	ND
	2100	xiv	ND
	CCRI-12480	li	ND
	CCRI-12496	li	ND
	CCRI-12640 ²	li	ND
	CCRI-9866 2	ii mut36	ND
	48	iiii	V
	347101	iii	V
	CCRI-12503	lli	ND
	CCRI-12790	lii	ND
	CCRI-12608	iv	ND
	CCRI-8895	IV	111
	CCRI-1263(R523)	V	IV
	CCRI-12767	V	ND
	571	VI	ND
	MLST 22 HOS47.3.270206 MJS	Vi	ND
	CCRI-12425 2	Vii	ND
	CCRI-12763	vii	ND
	CCRI-9583	VII	ll
	CCRI-9711	VII	ND
	521	Vi	ND
	CCRI-9681	ix	ND
	494	xiiii	ND
	ST2011 11005	xxi	ND
	126	xiv	ND
	CCRI-8894	İ	l
	MAH 20°	xxi	ND
	MAH 15	xxi	ND
	CCRI-1262	ili	III
	CCRI-2025	V	IV
	CCRI-9773	vii	==
	CCRI-9624	ii mut36	ND

Table 7: MRSA Strains Tested in the Inclusivity Study of the BD MAX™ StaphSR Assay.

{9}------------------------------------------------

The initial result was negative for MRSA. Both samples (ATCC BAA42 and VRS4) were repeated from the SBT and assay results are
conforming (SA+, MRSA+).

{10}------------------------------------------------

2These are the results for the repeats as the initial run gave an IND result due to a PCR heater warning. 3VRSA strains (http://www.narsa.net/control/member/repositories) 4VISA strains (http://www.narsa.net/control/member/repositories) أmecC variant strains

Evaluation of a Well Characterized Challenge Strain Panel

An additional analytical study was carried out to evaluate the analytical performance of the BD MAX™ StaphSR assay using a well characterized challenge strain panel:

Seventeen (17) out of 17 MRSA strains with high and low oxacillin minimum . inhibitory concentrations (MICs), including PFGE types USA 100 to 800, 1000, PFGE type IV/IBERIAN and mecC variant (mecA-containing S. aureus strain LGA251) tested at a concentration of 2-3 x LoD, exhibited SA POS, MRSA POS results.
Four (4) out of 4 BORSA strains (Borderline Oxacillin-Resistant S. aureus) . tested at ≥10° CFU/swab, exhibited SA POS, MRSA NEG results.
Five (5) out of 5 MSSA strains tested at ≥10° CFU/swab, exhibited SA POS, . MRSA NEG results
. One (1) out of 1 Methicillin-Resistant Staphylococcus epidermidis (MRSE) strains tested at ≥10° CFU/swab, exhibited a negative result (SA NEG, MRSA NEG).

Analytical Specificity

The BD MAX™ StaphSR assay was performed on samples containing high levels of non-target organisms and MSSA strains (Table 8), using the BD MAX™ System, to demonstrate the specificity of the assay for detection of MRSA and SA.

Fifteen (15) out of 15 empty cassette variant MSSA strains tested at ≥10° . CFU/swab produced SA POS, MRSA NEG results.
Fifty-seven (57) out of 57 strains of various non-staphylococcal species tested . at a concentration of at least ≥10° CFU/mL (except for Cryptococcus neoformans which was tested at 3x10* CFU/swab) produced negative results (SA NEG, MRSA NEG).
Forty-five (45) Coagulase-Negative staphylococcal strains (CoNS) and � Coagulase-Positive staphylococcal strains (CoPS) representing 28 species were tested at a concentration of 0.5 McFarland with the BD MAX™ StaphSR assay. Forty-five (45) of the 45 strains tested exhibited negative results (SA NEG, MRSA NEG).
Fifty (50) out of 50 MSSA strains tested at high concentrations ≥10° . CFU/swab), produced SA POS, MRSA NEG results.
Seventeen (17) viruses representing 12 different viral species were tested at ≥ o 105 PFU/mL. All 17 viruses produced negative results (SA NEG, MRSA NEG).

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Table 8: Microorganisms Tested for the Analytical Specificity Study
Non-Staphylococcal Species
Acinetobacterbaumannii	Corynebacteriumbovis	Escherichia coli(3 strains)	Neisseriameningitidis	Pasteurellaaerogenes
Acinetobacterhaemolyticus	Corynebacteriumflavescens	Haemophilusinfluenzae	Streptococcusanginosus	Proteus mirabilis
Bacillus cereus	Corynebacteriumgenitalium	Klebsiella oxytoca	Streptococcusagalactiae	Proteus vulgaris
Bordetellapertussis	Cryptococcusneoformans	Klebsiellapneumoniae	Streptococcusmitis	Providencia stuartii
Candida albicans(2 strains)	Enterobacteraerogenes	Lactobacilluscrispatus	Streptococcusmutans	Pseudomonasaeruginosa
Candidaguilliermondii	Enterobactercloacae	Lactobacillusreuteri	Streptococcuspneumoniae	Pseudomonasfluorescens
Candida tropicalis	Enterococcusfaecalis	Lactobacillusacidophilus	Streptococcuspyogenes	Salmonellaenterica subsp.Enterica
Candida glabrata	Enterococcusfaecium	Listeriamonocytogenes	Streptococcussalivarius	Serratiamarcescens
Citrobacter freundii	Enterococcusflavescens	Micrococcus luteus	Streptococcussanguinis	Shigella sonnei
Citrobacter koseri	Enterococcus hirae	Moraxellacatarrhalis	Streptococcus suis	Yersiniaenterocolitica
Corynebacteriumaquaticus	Enterococcusgallinarum	Neisseriagonorrhoeae	Streptococcus sp.
Various Coagulase Positive Staphylococcus Species
Staphylococcusintermedius	Staphylococcuslutrae (2 stains)	Staphylococcuspseudointermedius	Staphylococcusschleiferi	Staphylococcusschleiferi subsp.coagulans
Staphylococcusdelphini
Various Coagulase Negative Staphylococcus Species
Staphylococcusarlettae	Staphylococcuschromogenes	Staphylococcusgallinarum	Staphylococcuslentus	Staphylococcussciuri
Staphylococcusauricularis	Staphylococcuscohnii subsp.urealyticum	Staphylococcushaemolyticus(3 strains)	Staphylococcuslugdunensis	Staphylococcussimulans
Staphylococcuscapitis	Staphylococcusepidermidis(9 strains)	Staphylococcushominis (3 strains)	Staphylococcuspasteuri	Staphylococcuswarneri (2 strains)
Staphylococcuscaprae	Staphylococcusequorum	Staphylococcushominis subsp.hominis	Staphylococcuspulvereri	Staphylococcusxylosus (2 strains)
Staphylococcuscarnosus	Staphylococcusfelis	Staphylococcuskloosii	Staphylococcussaprophyticus	Staphylococcusxylosus
Virus
Adenovirus(type 1 and 7A)	Enterovirus	Humanparainfluenza (type1, 2, 3)	Measles	Respiratorysyncytial virus
Humancoronavirus (2)	Epstein Barr Virus	Humanmetapneumovirus	Mumps virus	Rhinovirus
Cytomegalovirus	Human influenzavirus (type A andB)

Table 8: Microorganisms Tested for the Analytical Specificity Study

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Interfering Substances

Twenty nine (29) microorganisms and chemical substances occasionally used in the nares or found in nasal swab specimens were evaluated for potential interference with the BD MAX™ StaphSR assay (Table 9). MRSA negative samples and MRSA positive samples at 2-3 x LoD were tested with the highest amount of each compound or microorganism likely to be found at the sampling site or on the nasal swab sample. Results demonstrated no reportable interference with any microorganisms or chemical substance except for Tobramycin that showed inhibition in the BD MAX™ StaphSR assay when tested at a concentration of 4.5 x 10-3 g/swab.

Table 9: Endogenous and Commercial Exogenous Substances Tested with the
BD MAX™ StaphSR Assay

Substance'	Result'
Mucin, from bovine submaxillary glands	NI
Dexamethasone Sodium Phosphate OphtalmicSolution	NI
USP, 0.1% Dexamethasone Phosphate EquivalentChloraseptic™	NI
Taro-Mupirocin, Mupirocin Ointment USP, 2%	NI
Long Lasting Dristan™ Nasal Mist	NI
Neo-Synephrine™	NI
Equate® Nasal Spray Decongestant	NI
Beconase AQ™	NI
Flunisolide Nasal Solution USP, 0.025%	NI
Nasacort™ AQ	NI
Nasonex™	NI
Relenza™	NI
Tobramycin	I
Blood	NI
Flumist®	NI
Substance	Result
Rhinocort aqua™	NI
Zicam® No-Drip Liquid™ NasalGel™ Extreme CongestionRelief	NI
Fluticasone Propionate	NI
Luffeel™	NI
Staphylococcus epidermidis	NI
Micrococcus luteus	NI
Enterococcus faecium	NI
Enterococcus faecalis	NI
Escherichia coli	NI
Corynebacterium flavescens	NI
Moraxella catarrhalis	NI
Staphylococcus hominis subsphominis	NI
Haemophilus influenzae	NI
Streptococcus pneumoniae	NI

NI: No reportable interference with the BD MAX™ StaphSR assay.

I: Reportable interference with the BD MAX™ StaphSR assay.

Microbial Competitive Inhibitory Effect

A study was conducted to determine the potential competitive inhibitory effect of:

an increasing concentration of MRSE when co-spiked with a low concentration । (1-2 x LoD) of MRSA or MSSA, and
an increasing concentration of MSSA when co-spiked with a low concentration -(1-2 x LoD) of MRSA.

Results demonstrated competition from:

MRSE at an MRSA:MRSE ratio of 1: ≥ 1x103 で
MRSE at an MSSA:MRSE ratio of 1: ≥ 1x105 -
MSSA at an MRSA:MSSA ratio of 1: ≥ 1x104. ー

Carryover / Cross-Contamination

A study was conducted to investigate the potential for carry-over/cross-contamination between high MRSA (≥10' CFU/swab) specimens and negative specimens throughout the BD MAX™ StaphSR workflow. Twelve (12) replicates of the high

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positive sample and 12 replicates of the negative sample were tested in each run by alternating negative and positive replicates. Four (4) operators performed a total of 18 runs of 24 samples. Overall, from 203 reportable results out of 216 expected negative samples, 3 false positive results were obtained (3/203; 1.5%) due to carry-over contamination.

Clinical Performance Studies

Clinical performance characteristics of the BD MAX™ StaphSR assay were determined in a multi-site prospective investigational study. Three (3) investigational centers participated in the study. To be enrolled in the study, patients had to be eligible for MRSA or SA testing according to institutional policies. Eligibility requirements for targeted screening as per clinical site policies included, but were not limited to: patients admitted into the particular healthcare system; patients admitted to the Intensive Care Unit; patients transferred to the Intensive Care Unit; pre-elective surgery patients; and patients being admitted from long-term care facilities. Specimens from patients previously enrolled in the study were excluded.

The Comparative Reference Method consisted of direct culture complemented by enriched culture. Enriched culture analysis was completed for all specimens that were negative for MRSA or SA by direct culture. Presumptive S. aureus colonies observed on selective (S. aureus) chromogenic medium were subcultured onto Blood Agar (BA). Identification was confirmed with an agglutination test, while methicillin resistance was confirmed by Cefoxitin disk (30 µg) diffusion susceptibility testing. Enrichment in Trypticase Soy Broth with 6.5% NaCI (TSB 6.5% NaCI) was completed in the event that MRSA or SA was not confirmed by the initial direct culture method. Turbid TSB 6.5% NaCl broth was used to inoculate additional chromogenic medium and BA plates; MRSA confirmation was performed as described above.

Results Obtained with the BD MAX™ StaphSR Assay in Comparison to the Reference Method

A total of 2451 specimens were enrolled in the study. Of those, 94 specimens were regarded as noncompliant per protocol criteria and three (3) fully compliant specimens gave final non-reportable PCR results. A total of 2354 specimen results were used to determine the clinical performance of the BD MAX™ StaphSR assay in comparison to the Reference Method (Tables 10 to 13).

Compared to the Reference Method (Direct/Enriched Culture), the BD MAX™ StaphSR assay identified 93.1% of the MRSA positive specimens and 97.5% of the MRSA negative specimens (Table 10). For the population tested, this resulted in a Negative Predictive Value (NPV) of 99.5% and a Positive Predictive Value (PPV) of 73.2%.

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	All Sites	Reference Method
		MRSA Positive	Negative	Total
BD MAX TM StaphSR Assay	Positive	149	54	203
	Negative	11	2140	2151
	Total	160	2194	2354
Sensitivity: 93.1% (149/160) (95% CI: 88.1%, 96.1%)Specificity: 97.5% (2140/2194) (95% CI:96.8%, 98.1%)PPV: 73.2% (95% CI: 67.8%, 78.3%)NPV: 99.5% (95% CI: 99.1%, 99.7%)

Table 10: Results Obtained for MRSA with the BD MAX ™ StaphSR Assay in Comparison to the Reference Method

the Reference Method and the BD MAX ™ StaphSR assay.

· 12 of 54 MRSA False Positive BD MAX™ StaphSR specimens were also found to be positive after repeat of Reference Method

· 5 of 11 MRSA False Negative BD MAX™ StaphSR specimens were also found to be negative after repeat of Reference Method

	Table 11: Site-by-Site Performance Obtained for MRSA with the BD MAX™
	StaphSR Assay in Comparison to the Reference Method

Clinical Sites	Prevalence	Sensitivity (95% CI)	Specificity (95% CI)
Site 1	4.3% (41/960)	92.7% (38/41)(80.6%, 97.5%)	98.9% (908/918)(98.0%, 99.4%)
Site 2	5.8% (38/650)	86.8% (33/38)(72.7%, 94.2%)	98.5% (583/592)(97.1%, 99.2%)
Site 3	10.6% (81/765)	96.3% (78/81)(89.7%, 98.7%)	94.9% (649/684)(93.0%, 96.3%)
Overall	6.7% (160/2375)	93.1% (149/160)(88.1%, 96.1%)	97.5% (2140/2194)(96.8%, 98.1%)

. Prevalence based on reference method only

b Confidence interval

° 2375 specimens were reference method compliant

Compared to the Reference Method (Direct/Enriched Culture), the BD MAX™ StaphSR assay identified 92.0% of the SA positive specimens and 93.1% of the SA negative specimens (Tables 12 and 13). For the population tested, this resulted in a NPV of 96.8% and a PPV of 83.4%.

	Table 12: Results Obtained for SA with the BD MAX™
	StaphSR Assay in Comparison to the Reference Method

	Reference Method
All Sites	SA	Positive	Negative	Total
	Positive	599	118	717
BD MAXTM StaphSR Assay	Negative	52	1585	1637
	Total	651	1703	23541
Sensitivity: 92.0% (599/651) (95% CI: 89.7%, 93.9%)
Specificity: 93.1% (1585/1703) (95% CI: 91.8%, 94.2%)
PPV: 83.4% (95% CI: 81.9%, 85.8%)
NPV: 96.8% (95% CI: 96.0%, 97.6%)
1Further investigation was performed on specimens with discordant results between
the Reference Method and the BD MAXTM StaphSR assay.
28 of 118 SA False Positive BD MAXTM StaphSR specimens were also

found to be positive after repeat of Reference Method

23 of 52 SA False Negative BD MAX™ StaphSR specimens were also � found to be negative after repeat of Reference Method

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Clinical Sites	Prevalence	Sensitivity with 95% CI	Specificity with 95% CI
Site 1	27.2% (261/960)	90.0% (235/261)(85.8%, 93.1%)	96.3% (672/698)(94.6%, 97.4%)
Site 2	27.5% (179/650)	91.5% (162/177)(86.5%, 94.8%)	90.9% (412/453)(88.0%, 93.3%)
Site 3	27.8% (213/765)	94.8% (202/213)(91.0%, 97.1%)	90.8% (501/552)(88.1%, 92.9%)
Overall	27.5% (653/2375)	92.0% (599/561)(89.7%, 93.9%)	93.1% (1585/1703)(91.8%, 94.2%)

Table 13: Site-by-Site Performance Obtained for SA with the BD MAX™ StaphSR Assay in Comparison to the Reference Method

a Prevalence based on reference method only

6 Confidence interval

€ 2375 specimens were reference method compliant

Results Obtained with the BD MAX™ StaphSR Assay in Comparison to Direct Culture

A total of 2451 specimens were enrolled in the study. Of those, 54 specimens were regarded as noncompliant per protocol criteria and four (4) fully compliant specimens gave non reportable PCR results. A total of 2393 specimen results were used to determine the positive and negative percent agreement of the BD MAX™ StaphSR assay in comparison to Direct Culture (Tables 14 to 17).

Compared to Direct Culture, the BD MAX™ StaphSR assay identified 96.5% of the MRSA positive specimens and 96.9% of the MRSA negative specimens (Tables 14 and 15).

		Direct Culture
All Sites		Positive	Negative	Total
BD MAX™ StaphSR Assay	Positive	137	69	206
	Negative	5	2182	2187
	Total	142	2251	2393
Positive Percent Agreement: 96.5% (137/142) (95% CI: 92.0%, 98.5%)
Negative Percent Agreement: 96.9% (2182/2251) (95% CI: 96.1%, 97.6%)

Table 14: Results Obtained for MRSA with the BD MAX™ StaphSR Assay in Comparison to Direct Culture

Table 15: Site-by-Site Performance Obtained for MRSA with the BD MAX™ StaphSR Assay in Comparison to Direct Culture

ClinicalSites	Positive PercentAgreement with 95%CI	Negative PercentAgreement with 95%CI
Site 1	100% (35/35)(90.1%, 100%)	98.6% (911/924)(97.6%, 99.2%)
Site 2	93.5% (29/31)(79.3%, 98.2%)	97.8% (586/599)(96.3%, 98.7%)
Site 3	96.1% (73/76)(89.0%, 98.6%)	94.1% (685/728)(92.1%, 95.6%)
Overall	96.5% (137/142)(92.0%, 98.5%)	96.9% (2182/2251)(96.1%, 97.6%)

8 Confidence interval

{16}------------------------------------------------

Compared to Direct Culture, the BD MAX™ StaphSR assay identified 95.1% of the SA positive specimens and 90.9% of the SA negative specimens (Tables 16 and 17).

Table 16: Results Obtained for SA with the BD MAX™ StanhSR Assay in Comparison to Direct Culture

All Sites		Direct Culture
		Positive	Negative	Total
BD MAX TM StaphSR Assay	Positive	564	164	728
	Negative	29	1636	1665
	Total	593	1800	2393
Positive Percent Agreement: 95.1% (564/593) (95% CI: 93.1%, 96.6%)
Negative Percent Agreement: 90.9% (1636/1800) (95% CI: 89.5%, 92.1%)

Table 17: Site-by-Site Performance Obtained for SA with the BD MAX™ StaphSR Assay in Comparison to Direct Culture

ClinicalSites	Positive PercentAgreement with95% CIa	Negative PercentAgreement with 95%CIa
Site 1	93.0% (213/229)(89.0%, 95.7%)	93.4% (682/730)(91.4%, 95.0%)
Site 2	94.9% (149/157)(90.3%, 97.4%)	88.6% (419/473)(85.4%, 91.1%)
Site 3	97.6% (202/207)(94.5%, 99.0%)	89.6% (535/597)(86.9, 91.8%)
Overall	95.1% (564/593)(93.1%, 96.6%)	90.9% (1636/1800)(89.5%, 92.1%)

8 Confidence interval

Out of 2399 nasal swab specimens tested with the BD MAX™ StaphSR assay that were compliant at the specimen and PCR level, 15 (0.6%) were reported as Unresolved after initial testing. The Unresolved Rate after repeat testing is 0.04% (1/2399) (Table 18).

Initial Unresolved Rates	Unresolved Rates After Repeat
0.6% (15/2399)* (95% CI: 0.4%, 1.0%)	0.04% (1/2399) (95% CI: 0%, 0.2%)
*Total number based on compliant specimens and BD MAX™ StaphSR assay results

*Total number based on compliant specimens and BD MAX™ StaphSR assay results

Out of the same 2399 nasal swab specimens tested with the BD MAX™ StaphSR assay, 14 (0.6%) were initially reported as Indeterminate. No result remained Indeterminate upon repeat (two specimens were not retested). Eight (8) (0.3%) were initially reported as Incomplete. No result remained Incomplete upon repeat (one specimen was not retested).

Empty Cassette Variants

Among the 2354 eligible specimens included in the clinical performance determination, a total of 10 specimens fit the empty cassette profile resulting in detection of MREU, without mecA or mecC gene detection. All of the 10 specimens were verified true negative MRSA and true positive SA relative to the Reference Method.

{17}------------------------------------------------

Expected Values

In the BD MAX™ StaphSR assay clinical study a total of 2395 reportable results, from specimens compliant at the specimen and PCR levels, were obtained from 3 geographically diverse sites and compared with Direct and Enriched culture. The study population was grouped into in-patient and unknown categories. The number and percentage of positive cases, as determined by the BD MAX™ StaphSR assay, are presented in the table below:

Group	Total NumberofSpecimens¹	BD MAX™ StaphSR Assay		PositiveMRSAPercentage	Positive SAPercentage
		Number ofMRSAPositive	Number of SAPositive
In-patient	1685	178	548	10.6%(178/1685)	32.5%(548/1685)
Out-patient	710	28	182	3.9%(28/710)	25.6%(182/710)
Total¹	2395	206	730	8.6%(206/2395)	30.5%(730/2395)

1Total specimens based on compliant PCR results.

{18}------------------------------------------------

Image /page/18/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the seal is a stylized symbol resembling an eagle or bird with three curved lines representing its wings or feathers.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Humpshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

GENEOHM SCIENCE CANADA. INC. (BD DIAGNOSTICS) PATRICIA DIONNE, PH.D, MBA DIRECTOR. REGULATORY AFFAIRS 2555 BOUL. DU PARC-TECHNOLOGIQUE QUEBEC, QUEBEC, GIP 4S5 CANADA

Re: K132822

Trade/Device Name: BD MAXTM StaphSR Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Code: NQX, OOI Dated: September 16, 2013 Received: September 17, 2013

November 26, 2013

Dear Dr. Dionne:

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 10 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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class 111 (PMA). it may be subject to 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 Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803): 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.

{19}------------------------------------------------

Page 2-Dr. Dionne

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.hum.

Sincerely yours.

Sally A. Hojvat -S

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological l-lealth Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132822

Device Name BD MAX™ StaphSR

Indications for Use (Describe)

The BD MAX™ StaphSR assay performed on the BD MAX™ System is an automated qualitative in vitro diagnostic test for the direct detection and differentiation of Staphylococus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. The test utilizes real-time polymense chain reaction (PCR) for the amplification of MRSA/SA DNA and fluorogenic arget-specific hybridization probes for the amplified DNA. The BD MAX™ StaphSR assay is intended to aid in the prevention and control of MRSA and SA infections in healthcare settings. It is not intended to diagnose MRSA or SA infections nor guide or monitor treatment for MRSA/SA infections. A negalive result does not preclude nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

. SEAR . . . . . . . . . . . . . . . . . . . . . FOR FOR FOR FOR FOR . . . . . . . . . . . . . - • Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Ribhi Shawar-S 2013.11.25 08:19:23 -05'00'

Image /page/20/Picture/17 description: The image shows a logo with the letters "FDA" in a stylized, geometric design. The letters are formed by a series of parallel lines, creating a layered effect. The logo is black and white and appears to be a simplified or abstract representation of the Food and Drug Administration logo.

FORM FDA 3881 (6/13)

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).