(71 days)
Not Found
No
The device uses an algorithm to interpret PCR results, but there is no indication of learning or adaptation, which are key characteristics of AI/ML. The algorithm is described as a fixed comparison of Cq values.
No
The device is described as a qualitative in vitro diagnostic test intended to aid in the prevention and control of MRSA infections by detecting SA and MRSA DNA from nasal swabs. It is specifically stated that "It is not intended to diagnose, guide or monitor MRSA infections." This indicates that it is a diagnostic tool, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states that the device is "a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA)..." Even though it clarifies that "It is not intended to diagnose, guide or monitor MRSA infections," its primary function is still detection for diagnostic purposes (to "aid in the prevention and control of MRSA infections").
No
The device is a qualitative in vitro diagnostic test that involves physical components like nasal swabs, reagents, a bioMérieux NucliSENS® easyMAG® instrument, and an Applied Biosystems 7500 FAST Dx System for sample processing, amplification, and detection. While it uses software for result determination, it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The very first sentence explicitly states: "MRSA/SA ELITe MGB® is a qualitative in vitro diagnostic test..." This is the most direct confirmation.
- Nature of the Test: The device performs a test on a biological sample (DNA purified from nasal swabs) outside of the body ("in vitro").
- Purpose: The test is intended to detect specific analytes (Staphylococcus aureus and methicillin-resistant Staphylococcus aureus DNA) to aid in the prevention and control of MRSA infections in healthcare settings. This aligns with the purpose of an IVD, which is to provide information about a patient's health status.
- Device Description: The description details the use of reagents, instruments, and a process to analyze the sample, which is characteristic of an IVD.
N/A
Intended Use / Indications for Use
MRSA/SA ELITe MGB® is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) using DNA purified from nasal swabs. MRSA/SA ELITe MGB® is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose, guide or monitor MRSA infections, or provide results of susceptibility to oxacillin/methicilliin. A negative result does not preclude MRSA/SA (Staphylococcus aureus) nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.
Special conditions for use statement(s): Prescription Use Only.
Product codes (comma separated list FDA assigned to the subject device)
NQX, NSU, JJH
Device Description
MRSA/SA ELITe MGB® is a real-time, multiplex polymerase chain reaction (PCR) assay for the in vitro qualitative detection of MRSA and SA DNA extracted from human nasal swab samples. In this system, sample preparation and amplification/real-time detection are completed on separate instruments. Sample processing is completed on the bioMérieux NucliSENS® easyMAG® instrument with bioMérieux NucliSENS Nucleic Acid Extraction Reagents according to the manufacturer's instructions. Following processing, the extracted sample is placed in the well of a 96 well plate to which "monoreagent" is added. The monoreagent contains the primers and probes for the genes of interest and the internal control combined with master mix. The assay is performed on an Applied Biosystems 7500 FAST Dx System that consists of the 7500 FAST Dx instrument, a personal computer, 96-well plates and seals. The total system run time is 150 minutes consisting of 60 minutes for sample processing and about 90 minutes for the real time amplification and detection steps. The instrument never comes into contact with any fluids within the 96-well plate. Each disposable plate is intended to test up to 96 samples, controls or any mixture thereof. The 96-well plates are not re-usable and are specific to the system. The kit contains enough reagents for 100 reactions. One positive and one negative control are required for each PCR run; a Negative Processing Control and a Positive Processing Control are recommended to be run in each extraction run. The design of the assay includes systems to identify both the gene responsible for methicillin resistance and for a conserved portion of a gene unique to S. aureus. Thus, for a true "MRSA," both targets will be identified in roughly equal proportions. Results are determined by using an algorithm that compares output. Cq, from the cycler (called Ct in the output from the cvcler.) The algorithm is implemented for automatic results determination by analyzing the output Cq with ELITe MGB® software.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
a. Correlation with MRSA/SA ELITe MGB® manual calling algorithm
In accordance with guidance received from FDA in Q120176, the original data from K112937 was recalculated using ELITe MGB software.
Results of MRSA/SA ELITe MGB® using the ELITe MGB® Software exhibit 100% concordance with results of MRSA/SA ELITe MGB® using the manual calling algorithm found in the labeling for MRSA/SA ELITe MGB®.
b. Clinical Studies:
No further studies were performed since K112937. The change to automate the calling algorithm using ELITe MGB® software will not affect this performance.
c. Clinical Cut-off:
Not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
KJ32468
510(k) Summary
MRSA/SA ELITe MBG
-
Date: .
August 5, 2013
Epoch Biosciences MRSA/SA ELITe MGB®
Epoch Biosciences
21720 23td Dr SE, Suite 150 Bothell, WA 98021 USA
OCT 17 2013
.
- Contact Person:
Submitter:
Debra K. Hutson Director, QA/RA, North America 21720 23rd Dr SE, Suite 150 Bothell, WA 98021 Phone: 425-482-5174 425-482-5550 Fax: Email: d.hutson@elitechgroup.com
-
- Device Name: MRSA/SA ELITe MGB® Device Class: Class II Product Code: NQX Antimicrobial Susceptibility Test Powder Regulation name: Panel: 83 Microbiology Regulation Number: 21 CFR 866.1640
-
Predicate Device:
-
Intended Use MRSA/SA ELITe MGB® is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) using DNA purified from nasal swabs. MRSA/SA ELITe MGB® is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose, guide or monitor MRSA infections, or provide results of susceptibility to oxacillin/methicilliin. A negative result does not preclude MRSA/SA (Staphylococcus aureus) nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.
Special conditions for use statement(s): Prescription Use Only.
1
Device Description
MRSA/SA ELITe MGB® is a real-time, multiplex polymerase chain reaction (PCR) assay for the in vitro qualitative detection of MRSA and SA DNA extracted from human nasal swab samples. In this system, sample preparation and amplification/real-time detection are completed on separate instruments. Sample processing is completed on the bioMérieux NucliSENS® easyMAG® instrument with bioMérieux NucliSENS Nucleic Acid Extraction Reagents according to the manufacturer's instructions. Following processing, the extracted sample is placed in the well of a 96 well plate to which "monoreagent" is added. The monoreagent contains the primers and probes for the genes of interest and the internal control combined with master mix. The assay is performed on an Applied Biosystems 7500 FAST Dx System that consists of the 7500 FAST Dx instrument, a personal computer, 96-well plates and seals. The total system run time is 150 minutes consisting of 60 minutes for sample processing and about 90 minutes for the real time amplification and detection steps. The instrument never comes into contact with any fluids within the 96-well plate. Each disposable plate is intended to test up to 96 samples, controls or any mixture thereof. The 96-well plates are not re-usable and are specific to the system. The kit contains enough reagents for 100 reactions. One positive and one negative control are required for each PCR run; a Negative Processing Control and a Positive Processing Control are recommended to be run in each extraction run. The design of the assay includes systems to identify both the gene responsible for methicillin resistance and for a conserved portion of a gene unique to S. aureus. Thus, for a true "MRSA," both targets will be identified in roughly equal proportions. Results are determined by using an algorithm that compares output. Cq, from the cycler (called Ct in the output from the cvcler.) The algorithm is implemented for automatic results determination by analyzing the output Cq with ELITe MGB® software.
Substantial Equivalence Information - Assay (reagent)
-
- Predicate Device Name
- Epoch Bioscience MRSA/SA ELITe MGB®
-
- Comparison with predicate
Similarities
| Parameter | Test System
Epoch Bioscience MRSA/SA ELITe
MGB® using ELITe MGB® Software for
data analysis | Predicate Device
Epoch Bioscience MRSA/SA ELITe MGB®
K112937 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Intended Use /
Indication for
Use | MRSA/SA ELITe MGB® is a qualitative
in vitro diagnostic test for the direct
detection of Staphylococcus aureus
(SA) and methicillin-resistant
Staphylococcus aureus (MRSA) using
DNA purified from nasal swabs.
MRSA/SA ELITe MGB® is intended to
aid in the prevention and control of
MRSA infections in healthcare
settings. It is not intended to diagnose,
guide or monitor MRSA infections, or
provide results of susceptibility to | Same |
| Parameter | Test System | Predicate Device |
| | Epoch Bioscience MRSA/SA ELITE MGB® using ELITE MGB® Software for data analysis | Epoch Bioscience MRSA/SA ELITE MGB® K112937 |
| | oxacillin/methicillin. A negative result does not preclude MRSA/SA ( Staphylococcus aureus ) nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing. | |
| Mode of identification of S. aureus | Presence of conserved region in a Staphylococcus aureus -specific gene. | Same |
| Mode of detection for methicillin resistance | Presence of the mecA gene which is responsible for resistance to methicillin. | Same |
| Assay Format | Qualitative real-time polymerase chain reaction (PCR) assay using 3 forward primer, 3 reverse primers, and 3 fluorescent-labeled probes for the amplification and detection of Staphylococcus aureus (SA) and methicillin resistant Staphylococcus aureus (MRSA) DNA. | Same |
| Composition | MRSA/SA ELITE MGB® PCR Mix
Tfi PCR Master Mix