(50 days)
No
The description details a PCR-based assay with automated result interpretation by the instrument's software, but there is no mention of AI or ML algorithms being used for this interpretation or any other part of the process. The "Intelligent Cooling/Heating Optical Reaction" module refers to microprocessor control, not AI/ML.
No.
This device is an in vitro diagnostic test for detecting methicillin-resistant Staphylococcus aureus (MRSA) DNA, intended to aid in the prevention and control of MRSA infections. It does not directly treat or cure a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The BD GeneOhm™ MRSA ACP Assay is a 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." Furthermore, the "Device Description" also refers to it as a "qualitative in vitro diagnostic test."
No
The device description clearly outlines the use of physical components like nasal swabs, lysis kits, PCR reagents, reaction tubes, and the SmartCycler® II instrument, which is a hardware device. While software is used for interpretation, the device is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The BD GeneOhm™ MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs..."
The "Device Description" also refers to it as a "qualitative in vitro diagnostic test".
These statements clearly indicate that the device is intended for use outside of the body to examine specimens for diagnostic purposes, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BD GeneOhm™ MRSA ACP Assay is a 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 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 GeneOhm™ MRSA ACP 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 to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.
Product codes
NQX
Device Description
Not Found
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
Clinical performance characteristics of the BD GeneOhm™ MRSA ACP Assay were determined in a multi-site prospective investigational study. Three (3) investigational centers participated in the study. The Comparative Reference Method consisted of an initial analysis on a selective chromogenic media followed by subculture on Blood Agar (BA) of presumptive S. aureus colonies. Identification was confirmed with an agglutination test. while methicillin-resistance was confirmed by cefoxitin disk diffusion susceptibility testing. Results obtained for 1216 specimens are summarized in Tables 1 to 4.
Summary of Performance Studies
Clinical Performance: A multi-site prospective investigational study was conducted with 1216 specimens.
Overall Clinical Sensitivity: 92.0% (87.1%, 95.4%)
Overall Clinical Specificity: 94.6% (93%, 95.9%)
Overall Unresolved Rate (after repeat): 0.0% (0.0% - 0.3%)
Overall Invalid Run Rates: 4.4% (3/68) (0.9% - 12.4%)
Analytical Sensitivity (LoD) using Genomic DNA:
LoD ranged from 2.5 to 5 copies/PCR reaction, with an average of 5 DNA copies/PCR reaction.
Analytical Sensitivity (LoD) using Viable Bacteria with Clinical Nasal Matrix:
LoD ranged from 130 to 576 CFU/swab, with an average of 300 CFU/swab.
Analytical Inclusivity:
140 strains from 31 countries were tested (52 from public collections, 88 from clinical isolates).
99% of all strains were detected at the relevant clinical load (roughly 100 genome copies/μL).
Detected all MREJ wild types (i, iii, iii, iv, v, vii), and MREJ mutant types (ii mut25, iii mut25).
Detected MRSA SCCmec types I, II, III, IV, V, VI, and PFGE types USA 100 to 800, 1000, and 1100.
Detected VRSA and VISA strains.
Evaluation of a Well Characterized Challenge Strain Panel:
15 MRSA, 4 BORSA, 1 MRSE, and 5 MSSA strains were tested.
All MRSA strains (including PFGE types USA 100, 300, 400) exhibited positive results at 2-3X LoD.
All BORSA, MSSA, and MRSE strains exhibited negative results at high concentrations.
Analytical Specificity:
Tested 42 non-staphylococcal species: 41 produced negative results, 1 produced a positive result due to MRSA contamination.
Specificity with Coagulase Negative Staphylococci (MSCNS, MRCNS, CNS) was 100%.
Specificity with MSSA was 100% at ~ 3x10^4 copies/PCR reaction (~ 7 x 10^7 CFU/swab), and 95.5% at ~ 3x10^6 copies/PCR reaction (~ 7 x 10^7 CFU/swab).
Interfering Substances:
No reportable interference with 18 tested substances, except for blood when present in excess.
Rhinaris® and Secaris® at high concentrations showed slight inhibition, but expected assay results were still obtained.
Reproducibility:
Site-to-Site Reproducibility (3 clinical sites, 1 lot of reagents):
Overall percent agreement: 100% for Moderate Positive (MP) and Negative (Neg) categories, 95.0% for Low Positive (LP), 88.3% for High Negative 1:100 (HN1:100), and 47.2% for High Negative 1:10 (HN1:10).
Lot-to-Lot Reproducibility (1 clinical site, 3 lots of reagents):
Overall percent agreement: 100% for MP and Neg categories, 98.3% for LP, 91.7% for HN1:100, and 41.7% for HN1:10.
Precision:
Within-laboratory precision (1 site, 2 technologists, 12 days):
100% agreement for Neg, LP, and MP samples.
95.8% for HN1:100 and 41.7% for HN1:10.
Carry-Over Contamination:
No false positive results due to carry-over contamination observed over 16 runs.
Key Metrics
Sensitivity (Overall): 92.0% (87.1%, 95.4%)
Specificity (Overall): 94.6% (93%, 95.9%)
Unresolved Rates (Overall After Repeat): 0.0% (0.0% - 0.3%)
Invalid Run Rates (Overall): 4.4% (3/68) (0.9% - 12.4%)
Limit of Detection (Genomic DNA): Ranged from 2.5 to 5 copies/PCR reaction (average 5 copies/PCR reaction)
Limit of Detection (Viable Bacteria): Ranged from 130 to 576 CFU/swab (average 300 CFU/swab)
Analytical Inclusivity: 99% detection.
Analytical Specificity: 100% (with CNS and certain MSSA concentrations), 95.5% (with higher MSSA concentrations).
Predicate Device(s)
BD GeneOhm™ MRSA Assav (K042357), Cepheid Xpert MRSA Assay (K070462)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K093346
510(k) Summary DEC 1 5 2009 BD Diagnostics BD GeneOhm™ MRSA ACP Assay
Submitted By:
BD Diagnostics (GeneOhm Sciences Canada Inc.) 2555, Boul, du Parc-Technologique Québec (Québec) Canada G1P 4S5
Contact:
Patricia Dionne, Ph.D.
MRSA Detection Assay
BD GeneOhm™ MRSA ACP Assay
Date Prepared:
December 11, 2009
866.1640
Microbiology
NOX
Name of Device:
Trade Name: Common Name: Type of Test: Classification Name:
Regulation Number: Product Code: Classification advisory committee:
BD GeneOhm™ MRSA Assav (K042357) Cepheid Xpert MRSA Assay (K070462)
Nucleic Acid Amplification test, DNA, qualitative
non-resistant markers, Staphylococcus colonies
System, Test, Genotypic Detection, resistant and
Predicate Devices:
Device Description:
Intended Use:
The BD GeneOhm™ MRSA ACP Assay is a 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 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 GeneOhm™ MRSA ACP 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 to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.
Test Description:
A nasal specimen is collected and transported to the laboratory using a recommended swab. The lysis of bacterial cells in nasal swab specimens is performed using the BD GeneOhm™ MRSA ACP Lysis kit. An aliguot of the lysate is added to prepared PCR reagents which contain MRSA-specific primers that will amplify in the presence of genetic target. The assay also includes an Internal Control (IC) to monitor for the presence of inhibitors in the PCR reaction and to confirm the integrity of assay reagents.
1
BD Diagnostics BD GeneOhm™ MRSA ACP Assay
Controls and specimen lysates are added to disposable reaction tubes and placed in the SmartCycler® II instrument. The amplification, detection and results interpretation are automatically performed by the SmartCycler® II software. The BD GeneOhm™ MRSA ACP Assay procedure can be performed within 2 hours, depending on the number of specimens processed. To recover MRSA for epidemiological typing or for further antibiotic susceptibility testing, appropriate culture media can be inoculated during or up to 24 hours after specimen preparation.
The primers and probes in the BD GeneOhm™ MRSA ACP Assay detect a proprietary sequence inserted into the S. aureus chromosome indicating the presence of MRSA DNA. Amplification of IC and MRSA DNA are detected using specific hybridization probes that bind to a specific sequence of the amplified target. Differentiation of MRSA DNA and IC is done using molecular beacons which contain different fluorometric properties. The beacon-target hybrid fluoresces at a different wavelength for MRSA and IC and the emitted light from this reaction is measured by the SmartCycler® II instrument. MRSA or IC specific amplicons are detected simultaneously in two different fluorescence channels on the SmartCycler and can therefore be differentiated. The operation of the SmartCycler® II instrument is based on the proprietary microprocessor-controlled I-CORE® (Intelligent Cooling/Heating Optical Reaction) module.
Substantial Equivalence:
The BD GeneOhm™ MRSA ACP Assay is substantially equivalent the BD GeneOhm™ MRSA Assay (K042357) and the Cepheid Xpert MRSA Assay (K070462).
Performance Data:
Clinical performance characteristics of the BD GeneOhm™ MRSA ACP Assay were determined in a multi-site prospective investigational study. Three (3) investigational centers participated in the study. The Comparative Reference Method consisted of an initial analysis on a selective chromogenic media followed by subculture on Blood Agar (BA) of presumptive S. aureus colonies. Identification was confirmed with an agglutination test. while methicillin-resistance was confirmed by cefoxitin disk diffusion susceptibility testing. Results obtained for 1216 specimens are summarized in Tables 1 to 4.
Table 1: Results Obtained with the BD GeneOhm™ MRSA ACP Assay in Comparison with the Reference Method
| | Comparative
Reference
Method | | | |
|-------------------------------------|------------------------------------|-----|------|------|
| | + | - | | |
| BD
GeneOhm™
MRSA ACP
Assay | + | 172 | 56 | 228 |
| | - | 15 | 973 | 988 |
| | | 187 | 1029 | 1216 |
2
| Clinical
| Sites | Prevalence | Sensitivity with 95% CI* | Specificity with 95% CI* |
|---|---|---|---|
| Site 1 | 11.6% (67/579) | 94.0% (85.4%, 98.3%) | 96.7% (94.7%, 98.1%) |
| Site 2 | 17.5% (56/320) | 88.9% (77.4%, 95.8%) | 89.8% (85.4%, 93.2%) |
| Site 3 | 20.1% (66/329) | 92.4% (83.2%, 97.5%) | 95.1% (91.7%, 97.3%) |
| Overall | 15.4% (189/1228) | 92.0% (87.1%, 95.4%) | 94.6% (93%, 95.9%) |
Table 2: Performance Obtained using the BD GeneOhm™ MRSA ACP Assay in Comparison with the Reference Method
- CI: Confidence Intervals
Table 3: Unresolved Rates
| Clinical Sites | Initial unresolved rate
with 95% Cl* | | Unresolved rate after repeat
with 95% Cl* | |
|----------------|-----------------------------------------|---------------|----------------------------------------------|---------------|
| Site 1 | 1.0% (6/579) | (0.4% - 2.2%) | 0.0% (0/579) | (0.0% - 0.6%) |
| Site 2 | 0.3% (1/308) | (0.0% - 1.8%) | 0.0% (0/308) | (0.0% - 1.2%) |
| Site 3 | 1.5% (5/329) | (0.5% - 3.5%) | 0.0% (0/329) | (0.0% - 1.1%) |
| Overall | 1.0% (12/1216) | (0.5% - 1.7%) | 0.0% (0/1216) | (0.0% - 0.3%) |
- CI: Confidence Intervals
Table 4: Overall Invalid Run Rates
| Table 4: Overall Invalid Run Rates | ||
|---|---|---|
| Site | Invalid Run Rates with 95% CI* | |
| Site 1 | 0.0% (0/25) | (0.0% - 13.7%) |
| Site 2 | 4.5% (1/22) | (0.1% - 22.8%) |
| Site 3 | 9.5% (2/21) | (1.2% - 30.4%) |
| Overall | 4.4% (3/68) | (0.9% - 12.4%) |
| * CI: Confidence Intervals |
Cl: Confidence Intervals
Analytical Sensitivity:
Limit of Detection (LoD) Determination Using Genomic DNA:
The analytical sensitivity (limits of detection or LoDs) of the BD GeneOhm™ MRSA ACP Assay testing genomic DNA were determined using decreasing amount of quantified (copies/PCR reaction) genomic DNA from cultures of 6 MRSA strains that represent 6 MREJ genotypes (i, ii, iii, iii, iii, iii, iii) and 4 SCCmec types (I, III, III, IV). Each MRSA strain was tested in replicates of 48 per concentration by 2 different operators using 3 different lots of Iyophilized BD GeneOhm™ MRSA ACP Assay Master Mixes. Analytical sensitivity (LoD), defined as the lowest concentration at which ≥ 95% of all replicates tested positive, ranged from 2.5 to 5 copies/PCR reaction, with an average value of 5 DNA copies/PCR reaction.
| MRSA
Strain | MREJ
Genotype | SCCmec
Type | LoD Concentration |
|----------------|------------------|----------------|-------------------------|
| 1 | type i | I | 5 copies/PCR reaction |
| 2 | type ii | II | 5 copies/PCR reaction |
| 3 | type iii | III | 5 copies/PCR reaction |
| 4 | type iv | III | 5 copies/PCR reaction |
| 5 | type v | IV | 2.5 copies/PCR reaction |
| 6 | type vii | II | 5 copies/PCR reaction |
- 3 -
3
Limit of Detection (LoD) Determination Using Viable Bacteria with Clinical Nasal Matrix: The analytical sensitivity (limits of detection or LoDs) of the BD GeneOhm™ MRSA ACP Assay testing viable MRSA strains with clinical nasal matrix were determined using simulated positive swabs that were prepared by soaking swabs in a wide range of MRSA bacterial suspensions prepared and quantified from cultures of 6 MRSA strains that represent 6 MREJ genotypes (i, iii, iii, iv, v, and vii) and 4 SCCmec types (l, II, III, IV), and then discharged/eluted in pooled negative clinical nasal matrix. Each MRSA strain was tested in replicates of 24 per concentration by 2 different operators using 3 different lots of lyophilized BD GeneOhm™ MRSA ACP Assay Master Mixes. Analytical sensitivity (LoD), defined as the lowest concentration at which ≥ 95% of all replicates tested positive, ranged from 130 to 576 CFU/swab, with an average value of 300 CFU/swab.
| MRSA
Strain | MREJ
Genotype | SCCmec
Type | LoD
Concentration |
|----------------|------------------|----------------|----------------------|
| 1 | type i | I | 207 CFU/swab |
| 2 | type ii | II | 576 CFU/swab |
| 3 | type iii | III | 256 CFU/swab |
| 4 | type iv | III | 245 CFU/swab |
| 5 | type v | IV | 130 CFU/swab |
| 6 | type vii | II | 386 CFU/swab |
Analytical Inclusivity:
Analytical ubiquity of the BD GeneOhm™ MRSA ACP Assay was evaluated in the analytical inclusivity study. A variety of Staphylococcus aureus strains were included in the study taking into account geographic origin, MREJ genotype, SCCmec type, pulse field gel electrophoresis (PFGE) type, temporal diversity and susceptibility pattern. Onehundred-forty (140) strains from 31 countries were tested in this analytical inclusivity study, including 52 from public collections and 88 from well-characterized clinical isolates, including Vancomycin-resistant Staphylococcus aureus (VRSA) and Vancomycinintermediate Staphylococcus aureus (VISA) strains.
When tested at the relevant clinical load (roughly 100 genome copies/μL), 99% of all the strains were detected. The BD GeneOhm™MRSA ACP Assay detected all of the MREJ wild tvpes i, iii, iii, iv, v and vii tested, as well as MREJ mutant types ii mut25 and iii mut25. The BD GeneOhm™ MRSA ACP Assay detected MRSA SCCmec types I, II. III. IV. V and VI, as well as MRSA PFGE types USA 100 to 800, 1000 and 1100. All Staphylococcus aureus strains displaying additional resistance to vancomycin (VRSA and VISA) were also detected. When the same strains were tested in triplicate at concentrations Trade Name: BD GeneOhm MRSA ACP Assay Regulation Number: 21 CFR §866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Codes: NQX Dated: October 22, 2009 Received: October 26, 2009
Dear Mr. Boule:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA 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
9
CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5460. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Ludella M. Poole for
Sally A. Hoivat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
10
510(k) Number (if known): K093346
Device Name: BD GeneOhm™ MRSA ACP Assay
×
Indication for Use:
The BD GeneOhm™ MRSA ACP Assay is a 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 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 GeneOhm™ MRSA ACP 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 to guide or monitor treatment for MRSA infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing or for further susceptibility testing.
Prescription Use: (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices Evaluation and Safety (OIVD)
Luddie M. Poole
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
510(k): K093346