The BD MAX™ MRSA XT assay performed on the BD MAX™ System is an automated qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of MRSA DNA and fluorogenic target-specific hybridization probes for the detection of the amplified DNA. The BD MAX™ MRSA XT assay is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor guide or monitor treatment for MRSA 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™ MRSA XT 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 MRSA NEG, MRSA POS or 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

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study for BD MAX™ MRSA XT Assay

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for all performance analytical and clinical metrics. However, it presents the results of various studies which implicitly define the performance achieved. For the purpose of this response, I've inferred "acceptance criteria" from the satisfactory performance reported by the manufacturer. The clinical performance is compared against a "Reference Method" (Direct/Enriched Culture).

Metric / Study Category	Implied Acceptance Criteria (Based on reported performance considered acceptable)	Reported Device Performance (BD MAX™ MRSA XT)
Precision	High agreement for positive/negative samples, reasonable for low positives.	- True Negative (TN): 100% agreement - Moderate Positive (MP): 100% agreement - Low Positive (LP): 97.9% agreement - High Negative (HN): 60.4% agreement (No specific acceptance criterion defined for this category, but reported.)
Reproducibility (Site-to-Site)	High agreement for positive/negative samples, reasonable for low positives.	- MP: 100% agreement - TN: 100% agreement - LP: 96.7% agreement - HN: 63.3% agreement (No specific acceptance criterion defined for this category, but reported.)
Reproducibility (Lot-to-Lot)	High agreement for positive/negative samples, reasonable for low positives.	- MP: 100% agreement - TN: 100% agreement - LP: 96.7% agreement - HN: 61.1% agreement (No specific acceptance criterion defined for this category, but reported.)
Analytical Sensitivity (LoD)	Detection of MRSA strains at low concentrations.	LoD ranged from 64 to 343 CFU/swab at 95% positivity for various MRSA genotypes.
Analytical Inclusivity	Detection of a wide range of MRSA strains and types.	All 77 MRSA strains (across various MREJ genotypes, SCCmec types, PFGE types, geographic origins, and including VRSA/VISA) were detected at 2-3x LoD.
Analytical Specificity	No detection of non-target organisms (MSSA, CoNS, CoPS, other species, viruses).	- Empty cassette variant MSSA: 15/15 MRSA NEG - Non-staphylococcal species (57 strains): 57/57 MRSA NEG - Coagulase-Negative/Positive staphylococcal strains (45 strains): 45/45 MRSA NEG - MSSA (50 strains): 50/50 MRSA NEG - Viruses (17 species): 17/17 MRSA NEG
Interfering Substances	No interference from common nasal substances/microorganisms.	No reportable interference from 28/29 tested substances/microorganisms. Tobramycin showed reportable interference at 4.5 x 10^-3 g/swab.
Carryover/Cross-Contamination	Low rate of false positives due to carryover.	3 false positive results out of 210 expected negative results (1.4%).
Clinical Sensitivity (vs. Reference Method)	High agreement for positive specimens.	93.1% (95% CI: 88.1%, 96.1%)
Clinical Specificity (vs. Reference Method)	High agreement for negative specimens.	97.5% (95% CI: 96.8%, 98.1%)
Positive Predictive Value (PPV) (vs. Reference Method)	Reasonable PPV given prevalence.	73.2% (95% CI: 67.8%, 78.3%)
Negative Predictive Value (NPV) (vs. Reference Method)	High NPV.	99.5% (95% CI: 99.1%, 99.7%)
Positive Percent Agreement (vs. Direct Culture)	High agreement for positive specimens.	96.5% (95% CI: 92.0%, 98.5%)
Negative Percent Agreement (vs. Direct Culture)	High agreement for negative specimens.	96.9% (95% CI: 96.1%, 97.6%)
Unresolved Rate (Initial)	Low initial unresolved rate.	0.6% (16/2399)
Unresolved Rate (After Repeat)	Very low unresolved rate after repeat.	0.1% (2/2398)

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

Clinical Performance Study:
- Test Set Size:
  - Reference Method comparison: 2352 compliant specimen results used for sensitivity/specificity calculations. A total of 2451 specimens were initially enrolled, with 94 noncompliant and 5 non-reportable PCR results removed.
  - Direct Culture comparison: 2391 compliant specimen results used for positive/negative percent agreement. A total of 2451 specimens were initially enrolled, with 54 noncompliant and 6 non-reportable PCR results removed.
- Data Provenance: Multi-site prospective investigational study. Specimens were collected from patients at risk for nasal colonization from three investigational centers (countries not explicitly stated but typically within the regulatory region, e.g., North America for an FDA submission).
Analytical Studies (e.g., Sensitivity, Specificity, Inclusivity, Precision, Reproducibility): These studies used prepared samples (simulated nasal matrix, bacterial suspensions) and well-characterized strains from public collections and clinical isolates. The Analytical Inclusivity study explicitly states that 77 MRSA strains were from 27 countries.

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

The ground truth for the clinical performance study test set was established using a Comparative Reference Method consisting of direct culture complemented by enriched culture.
The document does not explicitly state the number of experts or their specific qualifications (e.g., microbiologists, lab technologists) involved in performing or interpreting these culture methods at the clinical sites. However, it details the laboratory procedures: presumptive S. aureus colonies on selective media, subculture to Blood Agar, identification confirmation with an agglutination test, and methicillin-resistance confirmation by Cefoxitin disk diffusion susceptibility testing. For enriched culture, TSB 6.5% NaCl broth was used, followed by inoculation of chromogenic medium and BA plates, with MRSA confirmation as described. This implies trained laboratory personnel using standardized microbiological techniques.

4. Adjudication Method for the Test Set

The document describes a "Reference Method" (Direct/Enriched Culture) as the independent ground truth standard.
For discordant results between the BD MAX™ MRSA XT assay and the Reference Method in the clinical study, further investigation was performed.
- "12 of 54 MRSA False Positive BD MAX™ MRSA XT specimens were found to be MRSA POS after repeat of Reference Method."
- "5 of 11 MRSA False Negative BD MAX™ MRSA XT specimens were found to be MRSA NEG after repeat of Reference Method."
- This indicates a form of adjudication by repeat testing using the Reference Method (culture) for discordant clinical samples. It is not a 2+1 or 3+1 expert consensus model, but rather re-evaluation using the established gold standard.

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

No, an MRMC comparative effectiveness study involving human readers/interpreters with and without AI assistance was not done.
This device is an automated in vitro diagnostic test (NAAT) for direct detection of MRSA DNA. Its results are automatically interpreted by the BD MAX™ System software (MRSA NEG, MRSA POS, MRSA UNR).
The comparison is between the automated device performance and traditional culture methods, not between human performance with and without AI assistance.

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

Yes, a standalone performance evaluation was done.
The entire premise of the analytical and clinical performance studies is to assess the BD MAX™ MRSA XT assay's performance as an automated qualitative in vitro diagnostic test. The device generates "MRSA NEG, MRSA POS or MRSA UNR (Unresolved)" results automatically.
The "Substantial Equivalence" section explicitly states that the "Interpretation of Test Results" is "Automated (Diagnostic software of BD MAX™ System)."
The clinical performance section directly compares "BD MAX™ MRSA XT Assay" results to the Reference Method and Direct Culture.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Clinical Performance Study: The ground truth for clinical performance was established by a Comparative Reference Method consisting of direct culture complemented by enriched culture. This is a laboratory-based microbiological gold standard.
Analytical Performance Studies (e.g., LoD, Inclusivity, Specificity): The ground truth was established by known concentrations of characterized bacterial strains (e.g., CFU/swab), often from controlled laboratory settings or public reference collections.

8. The Sample Size for the Training Set

The document does not provide details about a specific training set size for the BD MAX™ MRSA XT assay's algorithm.
This is a molecular diagnostic test (PCR), and its performance is determined by the design and optimization of the primers and probes, and the reaction conditions, rather than a machine learning model that requires a "training set" in the conventional sense of AI. The analytical validation experiments (LoD, inclusivity, specificity) are used to characterize the assay's performance across a wide range of relevant targets and non-targets, ensuring its robustness and accuracy.

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

As noted above, the concept of a "training set" in the context of a machine learning algorithm is not directly applicable here.
The development and optimization of the PCR assay would involve:
- Designing primers and probes to target specific MRSA DNA sequences (e.g., MREJ, mecA, mecC).
- Testing against characterized bacterial strains with known genotypes, SCCmec types, and concentrations to ensure accurate detection and specificity.
- Optimizing reaction parameters (e.g., temperatures, times, reagent concentrations).
The ground truth for these developmental and optimization activities would be derived from established molecular biology techniques, bacterial genotyping, sequencing, and quantitative culturing methods to confirm the presence, identity, and concentration of target DNA.

Summary

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DEC 2 0 2013

510(k) Summary December 16, 2013 BD MAX™MRSA XT GeneOhm Sciences Canada Inc. (BD Diagnostics) Submitted by: 2555 Boul. Parc-Technologique Quebec (Quebec), Canada G1P 4S5 Patricia Dionne, Ph.D. Contact: Device: 510(k) Number: K133605 Trade Name: BD MAX™ MRSA XT Methicillin-resistant Staphylococcus aureus detection assay Common Name: Methicillin-resistant Staphylococcus aureus Qualitative Type of Test: Nucleic Acid Amplification Test from nasal swab specimens = Classification: Antimicrobial susceptibility test powder Regulation Name: 866. 1640 Regulation Number: Product Code: NQX, OOI Panel: Microbiology (83) BD MAX™ MRSA Assay Predicate Devices: Predicate 510(k) Numbers: K120138

Intended Use:

હ્યું

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

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necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Indication for Use:

Special Conditions for Use Statement: For prescription use

Special Instrument Requirements:

The BD MAX™ System

Device Description:

Test Principle:

The BD MAX™ MRSA XT assay performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct, qualitative detection of the 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™ MRSA XT Sample Buffer Tube. The Sample Buffer Tube is closed with a septum cap and vortexed. A worklist is created and the

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Sample Buffer Tube, the BD MAX™ MRSA XT 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 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 (TaqMan®) 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 and SPC amplicons in three 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 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 three optical channels used for the BD MAX™ MRSA XT 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™ MRSA XT assay and the predicate devices.

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	DEVICE	PREDICATE
ITEM	BD MAX™ MRSA XT	BD MAX MRSA Assay(K120138)
Intended Use	The BD MAX™ MRSA XT assayperformed on the BD MAX ™System is an automatedqualitative in vitro diagnostic testfor 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 XT assayis intended to aid in theprevention and control of MRSAinfections in healthcare settings.It is not intended to diagnoseMRSA infections nor guide ormonitor treatment for MRSAinfections. A negative resultdoes not preclude nasalcolonization. Concomitantcultures are necessary torecover organisms forepidemiological typing or forfurther susceptibility testing.	Same
Specimen type	Nasal swabs	Same
Assay Format	Amplification: PCRDetection: Fluorogenic target-specific hybridization	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)
Interpretation ofTest Results	Automated (Diagnostic softwareof BD MAX™ System)	Same
Analysis Platform	BD MAX™ System	Same
PCR SamplePreparation	Automated by the BD MAX ™System	Same
Detection Probes	TagMan® Probe	Same
Assay Controls	Specimen Processing Control(SPC)	Same

Table 1: Substantial Equivalence Information

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Analytical Performance:

Precision

Within-laboratory precision was evaluated for the BD MAX™ MRSA XT assay at one (1) site. The Precision panel consisted of 4 sample categories near the LoD. Each specimen contained simulated nasal matrix. MRSA 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 .
High Negative (HN) (MRSA MREJ Type ii): < 1 x LoD .
True negative (TN): Negative specimen (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 60.4% 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.

For Site-to-Site Reproducibility, the overall percent agreement was 100% for MP and TN categories; 96.7% for LP and 63.3% for HN (Table 2).

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	Carlos and Children		. SITE	1999 - 1998 - 1999
Category	Overall Percent Coverallපිහිටා පිහිටා විසින් විසින් මිනි මිනිම මෙයි.Site 3Site 1
	PercentAgreement	Count	Percent : IAdreement	Count	PercentAgreement	Count
HNMRSA1	60.0	18/30	66.7	20/30	63.3	19/30	63.3	(53.0%, 72.6%)²
LP MRSA	95.0	57/60	98.3	59160	96.7	28/20	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%)
TN1	100.0	30/30	100.0	30/30	100.0	30/30	100.0	1(95.9%, 100.0%)

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

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

For Lot-to-Lot Reproducibility, the overall percent agreement was 100% for MP and TN; 96.7% for LP and 61.1% for HN (Table 3).

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

Category	Lot 1		Lot 2		Lot 3		Overall Percent Agreement
	PercentAgreement	Count	PercentAgreement	Count	PercentAgreement	Count
HN MRSA¹	63.3%	19/30	63.3%	19/30	56.7%	17/30	61.1%	(50.8%, 70.5%)²
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%)
TN¹	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 criterion was defined for the high negative sample category.

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.

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		Site-to-Site			Lot-to-Lot
		HN MRSA	LP MRSA	MP MRSA	HN MRSA	LP MRSA	MP MRSA
MREJ1 (typespooled)	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)	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%
SPC3	N	57	90		55	90
	Mean	30.3	30.2		30.0	30.0
	SD	0.74	0.63		0.45	0.45
	%CV	2.5%	2.1%		1.5%	1.5%

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

1Values shown are those obtained for the MREJ target in the samples that gave a MRSA POS result

2Values shown are those obtained for the mecC target in the samples that gave a MRSA POS result

3Calculated for the Specimen Processing Control of the samples that gave a MRSA NEG result

Sample Storage

Specimens can be stored at 25 ± 2℃ for a maximum of 48 hours or at 2-8 ℃ 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) can be used as positive control. Staphylococcus epidermidis strain (e.g. ATCC 12228) can be used as negative control.].
Previously characterized specimens known to be positive or negative for 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™ MRSA XT assay was determined as follows: positive specimens were prepared by soaking swabs in a wide range of MRSA bacterial suspensions prepared and quantified from cultures. The tested strains included 11 MRSA strains representing 11 MREJ genotypes (i, iii, iii, iii, ix, xiii, xiv and xxi) corresponding to 5 SCCmec types (l, II, III, IV and XI). The swabs were then eluted in simulated nasal matrix. Each MRSA

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strain was tested in replicates of 24 per concentration by 2 different operators using 3 different production lots. Analytical sensitivity (LoD), defined as the lowest concentration at which 95% of all replicates tested positive, ranged from 64 to 343 CFU/swab (Table 5) for the detection of MRSA strains.

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

MRSA Strain	MREJ Genotype	SCCmec type1	LoD Concentration[CFU/swab (95% CI4)] .
1	Type i		84(49, 142)
2	Туре іі		103(64, 167)
3	Type iii		160(93, 278)
ব	Type iv		(42, 109)દિવ
5	Type v	IV	128 (73, 225)
6	Type vi	ND³	343 (186, 632)
7	Type vii		219 (110, 439)
8	Type ix	ND³	144(82, 255)
ਰੇ	Type xiii	ND°	64(36, 114)
10	Type xiv	ND°	(48, 127)78
11	Type xxi"	XI	112 (64, 197)

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

2CI: Confidence Intervals

3ND = not determined

4 mecC-containing MRSA strains (Also known as mecALGA257 strain)

Analytical Inclusivity

An analytical inclusivity study was performed using a variety of MRSA strains, taking into account geographic origin, MREJ genotype (wild type and mutant), SCCmectype, Pulsed-Field Gel Electrophoresis (PFGE) type, temporal diversity and susceptibility pattern. Seventy-seven (77) MRSA strains from 27 countries (see Table 6) were tested in this study, including strains from public collections and from wellcharacterized clinical isolates, including Vancomycin-Resistant Staphylococcus aureus (VRSA) and Vancomycin Intermediate Staphylococcus aureus (VISA) strains.

The BD MAX™ MRSA XT 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™ MRSA XT assay detected MRSA SCCmec types I, II, III, IV, V, VI, VII, 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.

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Collection	ReferenceNumber	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
	7909	ii	IV / USA300
	7916	ii	IV / USA300
	7917	ii	IV / USA300
	7921	ii	IV / USA300
	7922	ii	IV / USA300
	7913	ii mut36	IV / USA400
	NA	ii	IV / USA 800
	15555	xxi	ND
	MAH 305	xxi	ND
Collection	ReferenceNumber	MREJType	SCCmectyping / PFGEtype
	CCRI-11840	i	VIII
	JCSC6082	iii	VII
	92	xiii	ND
	5109	xiv	ND
	CCRI-12480	ii	ND
	CCRI-12496	ii	ND
	CCRI-126402	ii	ND
	CCRI-98662	ii mut36	ND
	48	iii	V
	347101	iii	V
	CCRI-12503	iii	ND
	CCRI-12790	iii	ND
	CCRI-12608	iv	ND
	CCRI-8895	iv	III
	CCRI-1263(R523)	v	IV
	CCRI-12767	v	ND
	571	vi	ND
	MLST 22 HOS47.3.270206 MJS	vi	ND
	CCRI-124252	vii	ND
	CCRI-12763	vii	ND
	CCRI-9583	vii	II
	CCRI-9711	vii	ND
	521	vi	ND
	CCRI-9681	ix	ND
	494	xiii	ND
	ST2011 11005	xxi	ND
	126	xiv	ND
	CCRI-8894	i	I
	MAH 205	xxi	ND
	MAH 15	xxi	ND
	CCRI-1262	iii	III
	CCRI-2025	v	IV
	CCRI-9773	vii	II
	CCRI-9624	ii mut36	ND

Table 6: MRSA Strains Tested in the Inclusivity Study of
the BD MAX™ MRSA XT Assay.

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The initial result was negative for MRSA. Both samples (ATCC BAA-42 and VRS4) were repeated from the SBT and assay results are conforming (SA POS, MRSA POS).

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) *mecC variant strains

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Evaluation of a Well Characterized Challenge Strain Panel

An additional analytical study was carried out to evaluate the analytical performance of the BD MAX™ MRSA XT 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 MRSA POS results.
Four (4) out of 4 BORSA strains (Borderline Oxacillin-Resistant S. aureus) . tested at ≥10° CFU/swab, exhibited MRSA NEG results.
Five (5) out of 5 MSSA strains tested at ≥10° CFU/swab, exhibited MRSA NEG . results
One (1) out of 1 Methicillin-Resistant Staphylococcus epidermidis (MRSE) . strain tested at ≥10° CFU/swab exhibited an MRSA NEG result.

Analytical Specificity

The BD MAX™ MRSA XT assay was performed on samples containing high levels of non-target organisms and MSSA strains (Table 7), using the BD MAX™ System, to demonstrate the specificity of the assay for detection of MRSA.

Fifteen (15) out of 15 empty cassette variant MSSA strains tested at ≥10° . CFU/swab produced 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 3x105 CFU/swab) produced MRSA NEG results.
Forty-five (45) Coaqulase-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™ MRSA XT assay. Forty-five (45) of the 45 strains tested exhibited MRSA NEG results.
Fifty (50) out of 50 MSSA strains tested at high concentrations ≥10° . CFU/swab, produced MRSA NEG results.
Seventeen (17) viruses representing 12 different viral species were tested at ≥ . 10° PFU/mL. All 17 viruses produced MRSA NEG results.

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Table 7: Microorganisms Tested for the Analytical Specificity Study
Non-Staphylococcal Species
Acinetobaterbaumannii	Corynebacteriumbovis	Escherichia coli(3 strains)	Neisseriameningitidis	Pasteurellaaerogenes
Acinetobaterhaemolyticus	Corynebacteriumflavescens	Haemophilusinfluenzae	Streptococcusanginosus	Proteus mirabilis
Bacillus cereus	Corynebacteriumgenitalium	Klebsiella oxytoca	Streptococcusagalactiae	Proteus vulgaris
Bordetellapertussis	Cryptococcusneoformans	Klebsiellapneumoniae	Streptococcusmitis	Providencia stuarti
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	Enterrococcusgallinarum	Neisseriagonorrhoeae	Streptococcus sp.
Various Coagulase Positive Staphylococcus Species
Staphylococcusintermedius	Staphylococcuslutrae (2 stains)	Staphylococcuspseudointermedius	Staphylococcusschleiferi	Staphylococcusschleiferi subscoagulans
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)
Staphylococcuscamosus	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 7: 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™ MRSA XT assay (Table 8). 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 interference with the BD MAX™ MRSA XT assay when tested at a concentration of 4.5 x 10-3 g/swab.

	Table 8: Endogenous and Commercial Exogenous Substances Tested with the BD
	MAX™ MRSA XT 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™ MRSA XT assay.

I: Reportable interference with the BD MAX™ MRSA XT assay.

Microbial Competitive Inhibitory Effect

Potential microbial inhibitory effect was evaluated with an increasing concentration of MRSE or 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 ।
MSSA at an MRSA:MSSA ratio of 1: ≥ 1x104 -

Carryover / Cross-Contamination

A study was conducted to investigate the potential for carry-over/cross-contamination between high MRSA (≥10 CFU/swab) specimens and neqative specimens throughout the BD MAX™ MRSA XT workflow. Twelve (12) replicates of the high 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 210 reportable results out of 216 expected negative results, 3 false positive results were obtained (3/210; 1.4%) due to carry-over contamination.

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Clinical Performance Studies

Clinical performance characteristics of the BD MAX™ MRSA XT 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 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 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 Sov Broth with 6.5% NaCl (TSB 6.5% NaCl) was completed in the event that MRSA 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™ MRSA XT 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 five (5) fully compliant specimens gave final non-reportable PCR results. A total of 2352 specimen results were used to determine the clinical performance of the BD MAX™ MRSA XT assay in comparison to the Reference Method (Tables 9).

Compared to the Reference Method (Direct/Enriched Culture), the BD MAX™ MRSA XT assay identified 93.1% of the MRSA positive specimens and 97.5% of the MRSA neqative specimens (Table 9). For the population tested, this resulted in a Negative Predictive Value (NPV) of 99.5% and a Positive Predictive Value (PPV) of 73.2%.

	Reference Method
All Sites		MRSA	Positive	Negative	Total
BD MAX™ MRSA XT Assay	Positive	149	54	203
	Negative	11	2138	2149
	Total	160	2192	23521
Sensitivity: 93.1% (149/160) (95% CI: 88.1%, 96.1%)
Specificity: 97.5% (2138/2192) (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 9: Results Obtained for MRSA with the BD MAX™ MRSA
XT Assav in Comparison to the Reference Method

Further investigation was performed on specimens with discordant results between the Reference Method and the BD MAX™ MRSA XT assay.

· 12 of 54 MRSA False Positive BD MAX™ MRSA XT specimens were found to be MRSA POS after repeat of Reference Method

· 5 of 11 MRSA False Negative BD MAX™ MRSA XT specimens were found to be MRSA NEG after repeat of Reference Method

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Clinical Sites	Prevalence1	Sensitivity (95% CI)2	Specificity (95% CI)2
Site 1	4.3% (41/960)	92.7% (38/41)(80.6%, 97.5%)	98.9% (907/917)(98.0%, 99.4%)
Site 2	5.8% (38/650)	86.8% (33/38)(72.7%, 94.2%)	98.5% (582/591)(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% (160/23753)	93.1% (149/160)(88.1%, 96.1%)	97.5% (2138/2192)(96.8%, 98.1%)

Table 10: Site-by-Site Performance Obtained for MRSA with the BD MAX™ MRSA XT Assay in Comparison to the Reference Method

1 Prevalence based on reference method only

2 Confidence interval

3 2375 specimens were reference method compliant

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

A total of 2451 specimens were enrolled in the study. Of those, 54 nasal swab specimens were regarded as noncompliant per protocol criteria and six (6) fully compliant specimens gave final non-reportable PCR results. A total of 2391 specimen results were used to determine the positive and negative percent agreement of the BD MAX™ MRSA XT assay in comparison to Direct Culture (Table 11).

Compared to the Direct Culture, the BD MAX ™ MRSA XT assay identified 96.5% of the MRSA positive specimens and 96.9% of the MRSA negative specimens (Table 10).

All Sites		Direct Culture
		Positive	Negative	Total
	Positive	137	69	206
BD MAX™ MRSA XT Assay	Negative	5	2180	2185
	Total	142	2249	2391
Positive Percent Agreement: 96.5% (137/142) (95% CI: 92.0%. 98.5%)
Negative Percent Agreement: 96.9% (2180/2249) (95% CI: 96.1%, 97.6%)

Table 11: Results Obtained for MRSA with the BD MAX™ MRSA XT Assay in Comparison to Direct Culture

Table 12: Site-by-Site Performance Obtained for MRSA with the BD MAX™ MRSA XT Assay in Comparison to Direct Culture

ClinicalSites	Positive PercentAgreement with95% CI 1	Negative PercentAgreement with95% CI 1
Site 1	100% (35/35)(90.1%, 100%)	98.6% (910/923)(97.6%, 99.2%)
Site 2	93.5% (29/31)(79.3%, 98.2%)	97.8% (585/598)(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% (2180/2249)(96.1%, 97.6%)

1 Confidence interval

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Out of 2399 nasal swab specimens compliant at the specimen and PCR level, tested with the BD MAX™ MRSA XT assay, 16 (0.7%) were reported as Unresolved after initial testing. The Unresolved Rate after repeat testing is 0.1% (2/2398) (Table 13; (one specimen was not retested).

Table 13: Unresolved Rates

Initial Unresolved Rates	Unresolved Rates After Repeat0.1% (2/2398) (95% CI: 0%, 0.3%)
0.6% (16/2399) {95% Cl: 0.4%. 1.1%}
'Total number based on compliant specimens and BD MAX™ MRSA XT assay results

Out of 2399 nasal specimens tested with the BD MAX™ MRSA XT 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 2352 eligible specimens included in the clinical performance determination, a total of 10 specimens fit the empty cassette profile with a positive MREJ result, without mecA or mecC gene detection. These 10 specimens were found true negative (TN) MRSA specimens relative to Reference Method.

Expected Values

In the BD MAX™ MRSA XT assay clinical study a total of 2393 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 out-patient categories. The number and percentage of positive cases, as determined by the BD MAX™ MRSA XT assay, are presented in the table below:

Group	Total Numberof Specimens¹	BD MAX™ MRSA XT AssayNumber of MRSA Positive	Positive MRSAPercentage
In-patient	1683	178	10.6%(178/1683)
Out-patient	710	28	3.9%(28/710)
Total¹	2393	206	8.6%(203/2393)

1Total specimens based on compliant PCR results.

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Image /page/16/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire 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

December 20, 2013

Re: K133605

Trade/Device Name: BD MAX™ MRSA XT Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Code: NQX, OOI Dated: November 22, 2013 Received: November 25, 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 to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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 II (Special Controls) or class III (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 (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.

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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/Industrv/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.htm.

Sincerely yours.

Uwe Scherf -S for

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133602

・・・・・・

Device Name BD MAX™ MRSA XT

Indications for Use (Describe)

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

2 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.

FOR FOR FOR FOR FOR FOR FOR FOR CONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Ribhi Shawar -S

FDA

FORM FDA 3881 (6/13)

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

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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).