BD MAX MRSA XT, BD MAX INSTRUMENT

• K Number: K133605
• Device Name: BD MAX MRSA XT, BD MAX INSTRUMENT
• Manufacturer: GENEOHM SCIENCES CANADA, INC.
• Date Cleared: 2013-12-20 ( 25 days)
• Product Code: NQX OOI
• Regulation Number: 866.1640

Intended Use

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.

Predicate Devices

K120138

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on automated PCR and standard data interpretation based on predefined thresholds, with no mention of AI/ML terms or methodologies.

Therapeutic

No.
The device is described as an "automated qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA," and it explicitly states: "It is not intended to diagnose MRSA infections nor guide or monitor treatment for MRSA infections." This indicates it is a diagnostic tool, not a therapeutic one.

Diagnostic

Yes

The device is explicitly described as an "automated qualitative in vitro diagnostic test" intended for the direct detection of MRSA DNA to aid in the "prevention and control of MRSA infections." While it states it is "not intended to diagnose MRSA infections," its primary function is laboratory analysis that informs clinical assessment, which is a characteristic of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states that 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, in addition to the software.

IVD (In Vitro Diagnostic)

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

The "Intended Use / Indications for Use" section explicitly states: "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."

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

NQX, OOI

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Nasal swabs

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Healthcare settings

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

Not Found

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

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 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.

A total of 2451 specimens were enrolled in the clinical study.

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

Precision:
Within-laboratory precision was evaluated at one (1) site using 4 sample categories near the LoD (Moderate Positive, Low Positive, High Negative, True Negative). 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 used the same sample categories as the Precision Study. Samples were tested in triplicate, on 5 distinct days, with 2 panels tested by 2 different technologists, at 3 clinical sites using 1 lot of reagents (Site-to-Site). An extended study also tested 2 additional lots of reagents (Lot-to-Lot) at one of these sites.
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.
For Lot-to-Lot Reproducibility, the overall percent agreement was 100% for MP and TN; 96.7% for LP and 61.1% for HN.
SDPA values were analyzed as an additional means of assessing reproducibility. Mean SDPA values and variance components were presented for HN MRSA, LP MRSA, and MP MRSA for MREJ1, meca or mecC 2, and SPC3 targets.

Analytical Sensitivity (Limit of Detection or LoD):
The LoD was determined by testing MRSA bacterial suspensions from 11 MRSA strains (11 MREJ genotypes) in replicates of 24 per concentration by 2 operators using 3 production lots. The LoD ranged from 64 to 343 CFU/swab.

Analytical Inclusivity:
Seventy-seven (77) MRSA strains from 27 countries (including VRSA and VISA) were tested at low bacterial load (2-3 x LoD). The assay detected MREJ types i, ii, iii, iv, v, vi, vii, ix, xiii, xiv and xxi, and 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. All VRSA and VISA strains were detected.

Evaluation of a Well Characterized Challenge Strain Panel:
17 MRSA strains with high and low oxacillin MICs were tested at 2-3 x LoD and exhibited MRSA POS results.
4 BORSA strains tested at ≥10^6 CFU/swab exhibited MRSA NEG results.
5 MSSA strains tested at ≥10^6 CFU/swab exhibited MRSA NEG results.
1 MRSE strain tested at ≥10^6 CFU/swab exhibited an MRSA NEG result.

Analytical Specificity:
The assay was performed on samples containing high levels of non-target organisms and MSSA strains.
15 empty cassette variant MSSA strains tested at ≥10^6 CFU/swab produced MRSA NEG results.
57 non-staphylococcal species strains tested at ≥10^6 CFU/mL (except for C. neoformans) produced MRSA NEG results.
45 Coagulase-Negative staphylococcal (CoNS) and Coagulase-Positive staphylococcal (CoPS) strains (28 species) tested at 0.5 McFarland exhibited MRSA NEG results.
50 MSSA strains tested at high concentrations ≥10^6 CFU/swab produced MRSA NEG results.
17 viruses (12 species) tested at ≥10^6 PFU/mL produced MRSA NEG results.

Interfering Substances:
Twenty-nine (29) microorganisms and chemical substances were evaluated. All but Tobramycin (at 4.5 x 10^-3 g/swab) showed no reportable interference.

Microbial Competitive Inhibitory Effect:
Demonstrated competition from MRSE at an MRSA:MRSE ratio of 1: ≥ 1x10^3 and from MSSA at an MRSA:MSSA ratio of 1: ≥ 1x10^4.

Carryover / Cross-Contamination:
A study with 18 runs of 24 samples (alternating high positive and negative) performed by 4 operators showed 3 false positive results out of 210 expected negative results (1.4%).

Clinical Performance Study:
Multi-site prospective investigational study with 3 centers.
Sample size: 2352 compliant specimens (out of 2451 enrolled).
Comparative Reference Method: Direct culture complemented by enriched culture and Cefoxitin disk diffusion susceptibility testing.
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%)
Discordant results investigation: 12 of 54 MRSA False Positive BD MAX™ MRSA XT specimens found to be MRSA POS after repeat of Reference Method; 5 of 11 MRSA False Negative BD MAX™ MRSA XT specimens found to be MRSA NEG after repeat of Reference Method.

Comparison to Direct Culture:
Sample size: 2391 compliant specimens (out of 2451 enrolled).
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%)

Unresolved Rates:
Initial Unresolved Rate: 0.6% (16/2399).
Unresolved Rate After Repeat: 0.1% (2/2398).

Empty Cassette Variants:
10 specimens showed a positive MREJ result without mecA or mecC gene detection, and were found true negative MRSA specimens relative to Reference Method.

Expected Values:
Clinical study showed 8.6% overall positive MRSA percentage (203/2393) for all sites.
In-patient: 10.6% positive (178/1683).
Out-patient: 3.9% positive (28/710).

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

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%)

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%)

Unresolved Rates:
Initial: 0.6% (16/2399) {95% Cl: 0.4%. 1.1%}
After Repeat: 0.1% (2/2398) (95% CI: 0%, 0.3%)

Predicate Device(s)

K120138

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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:

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 testina.

Special Conditions for Use Statement: For prescription use

Special Instrument Requirements:

The BD MAX™ System

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.

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 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.	Same
Specimen type	Nasal swabs	Same
Assay Format	Amplification: PCR
Detection: Fluorogenic target-
specific hybridization	Same
Mode of Detection
for Methicillin
Resistance in
S.aureus	Presence of SCCmec cassette
at orfX junction and mecA or
mecC genes	Presence of SCCmec cassette
at orfX junction (specific to S.
aureus)
Interpretation of
Test Results	Automated (Diagnostic software
of BD MAX™ System)	Same
Analysis Platform	BD MAX™ System	Same
PCR Sample
Preparation	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 meca or mecC 2
  (MREJ types
  pooled) | 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 | Reference
Number | MREJ
Type | SCCmec
typing / PFGE
type |
|----------------------------------------------------------|--------------------------------|--------------|---------------------------------|
| 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 |
| Harmony
collection of
European
epidemic
MRSA | 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 | Reference
Number | MREJ
Type | SCCmec
typing / PFGE
type |
| | 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 HOS
47.3.270206 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
Acinetobater
baumannii	Corynebacterium
bovis	Escherichia coli
(3 strains)	Neisseria
meningitidis	Pasteurella
aerogenes
Acinetobater
haemolyticus	Corynebacterium
flavescens	Haemophilus
influenzae	Streptococcus
anginosus	Proteus mirabilis
Bacillus cereus	Corynebacterium
genitalium	Klebsiella oxytoca	Streptococcus
agalactiae	Proteus vulgaris
Bordetella
pertussis	Cryptococcus
neoformans	Klebsiella
pneumoniae	Streptococcus
mitis	Providencia stuarti
Candida albicans
(2 strains)	Enterobacter
aerogenes	Lactobacillus
crispatus	Streptococcus
mutans	Pseudomonas
aeruginosa
Candida
guilliermondii	Enterobacter
cloacae	Lactobacillus
reuteri	Streptococcus
pneumoniae	Pseudomonas
fluorescens
Candida tropicalis	Enterococcus
faecalis	Lactobacillus
acidophilus	Streptococcus
pyogenes	Salmonella
enterica subsp.
Enterica
Candida glabrata	Enterococcus
faecium	Listeria
monocytogenes	Streptococcus
salivarius	Serratia
marcescens
Citrobacter freundii	Enterococcus
flavescens	Micrococcus luteus	Streptococcus
sanguinis	Shigella sonnei
Citrobacter koseri	Enterococcus hirae	Moraxella
catarrhalis	Streptococcus suis	Yersinia
enterocolitica
Corynebacterium
aquaticus	Enterrococcus
gallinarum	Neisseria
gonorrhoeae	Streptococcus sp.
Various Coagulase Positive Staphylococcus Species
Staphylococcus
intermedius	Staphylococcus
lutrae (2 stains)	Staphylococcus
pseudointermedius	Staphylococcus
schleiferi	Staphylococcus
schleiferi subs
coagulans
Staphylococcus
delphini
Various Coagulase Negative Staphylococcus Species
Staphylococcus
arlettae	Staphylococcus
chromogenes	Staphylococcus
gallinarum	Staphylococcus
lentus	Staphylococcus
sciuri
Staphylococcus
auricularis	Staphylococcus
cohnii subsp.
urealyticum	Staphylococcus
haemolyticus
(3 strains)	Staphylococcus
lugdunensis	Staphylococcus
simulans
Staphylococcus
capitis	Staphylococcus
epidermidis
(9 strains)	Staphylococcus
hominis (3 strains)	Staphylococcus
pasteuri	Staphylococcus
warneri (2 strains)
Staphylococcus
caprae	Staphylococcus
equorum	Staphylococcus
hominis subsp.
hominis	Staphylococcus
pulvereri	Staphylococcus
xylosus (2 strains)
Staphylococcus
camosus	Staphylococcus
felis	Staphylococcus
kloosii	Staphylococcus
saprophyticus	Staphylococcus
xylosus
Virus
Adenovirus
(type 1 and 7A)	Enterovirus	Human
parainfluenza (type
1, 2, 3)	Measles	Respiratory
syncytial virus
Human
coronavirus (2)	Epstein Barr Virus	Human
metapneumovirus	Mumps virus	Rhinovirus
Cytomegalovirus	Human influenza
virus (type A and
B)

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 Ophtalmic
Solution	NI
USP, 0.1% Dexamethasone Phosphate Equivalent
Chloraseptic™	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™ Nasal
Gel™ Extreme Congestion
Relief	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 subsp
hominis	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

| Clinical
Sites | Positive Percent
Agreement with
95% CI 1 | Negative Percent
Agreement with
95% 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

15

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 Repeat
0.1% (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 Number
of Specimens¹ | BD MAX™ MRSA XT Assay
Number of MRSA Positive | Positive MRSA
Percentage |
|-------------|-------------------------------|--------------------------------------------------|-----------------------------|
| 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.

16

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.

17

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 [phone] or [phone] 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 [phone] or [phone] 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

18

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.

19

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