(223 days)
Not Found
No
The description details a standard PCR-based assay for detecting specific genes. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis is based on direct detection of fluorescent signals from amplified DNA, not on complex pattern recognition or learning algorithms.
No
The device is an in vitro diagnostic assay used for the qualitative detection of vancomycin resistance genes, acting as an aid to identify, prevent, and control vancomycin-resistant colonization. It is explicitly stated that it is "not intended to diagnose VRE infection nor to guide or monitor treatment of infection," which means it does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" states that the assay is an "in vitro diagnostic assay" and can be "used as an aid to identify, prevent and control vancomycin-resistant colonization". This indicates its role in diagnosing VRE colonization.
No
The device is an in vitro diagnostic assay that includes reagents and is performed on an Abbott m2000rt instrument, indicating it is a hardware-based system with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is an "in vitro diagnostic assay."
- Purpose: It is designed to detect specific nucleic acids (vanA and vanB genes) in human specimens (perirectal swabs, rectal swabs, or stool) to aid in identifying, preventing, and controlling vancomycin-resistant colonization. This is a diagnostic purpose performed outside of the body.
- Method: The device uses PCR amplification, a common technique in in vitro diagnostics.
- Specimens: It is performed on human specimens.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMDx VanR for Abbott m2000 assay is an in vitro diagnostic assay that uses polymerase chain reaction (PCR) amplification for the qualitative detection of nucleic acids encoding the vancomycin resistance genes vanA and/or vanB. The assay is performed directly on human perirectal swabs, rectal swabs, or stool specimens from patients at risk for Vancomycin Resistant Enterococcus (VRE) colonization. The IMDx VanR for Abbott m2000 assay detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci. The IMDx VanR for Abbott m2000 assay can be used as an aid to identify. prevent and control vancomycin-resistant colonization in healthcare settings. The IMDx VanR for Abbott m2000 assay is not intended to diagnose VRE infection nor to guide or monitor treatment of infection. Culture methods are necessary to recover organisms for epidemiology typing and confirmation testing.
Product codes (comma separated list FDA assigned to the subject device)
NIJ, OOI
Device Description
The IMDx VanR for Abbott m2000 assay is a PCR-based assay that targets regions unique to the vanA and vanB vancomycin resistance genes that may be associated with vancomycin resistant Enterococcus (VRE). Detection of the vanA and vanB genes is measured by the presence of fluorescently-labeled oligonucleotide probes that generate a fluorescent signal when specifically bound to amplified vanA and/or vanB PCR products. Differentiation of vanA from vanB is attained by labeling the oligonucleotide probes with different colored fluorescent dyes. The amplification cycle at which fluorescent signal is detected by the Abbott m2000rt is inversely proportional to the vanA and vanB DNA target level present in the sample.
The IMDx VanR for Abbott m2000 assay includes reagents for the detection of the assay process control, which contains inactivated bacteria, unrelated to enterococci, and is introduced into each specimen during sample preparation. The process control (also acting as an internal control (IC)) is co-extracted with the specimen and co-amplified in the same PCR reaction as the vanA and vanB targets. The IC demonstrates that the entire assay process has proceeded within specification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
perirectal swabs, rectal swabs, stool specimens
Indicated Patient Age Range
The subjects ranged in age from less than 1 to 98 years old.
Intended User / Care Setting
Not Found
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)
Analytical Performance
- Precision (Repeatability/Reproducibility): Assay precision was measured in four independent studies: within laboratory repeatability, user-to-user reproducibility, lot-to-lot reproducibility and instrument reproducibility using a seven-member panel consisting of one vanA and one vanB VRE strain at varying concentrations: Positive (2-3X LoD), Low Positive (LoD) and High Negative (= 95% of the time. Six strains of vancomycin-resistant Enterococcus, four VanA-type and two VanB-type, were tested. Dilutions of quantified bacterial stocks were tested in replicates of sixty (60). The LoD of the assay was estimated using probit analysis for each target (vanA and vanB).
- Analytical Reactivity: Eighty-eight (88) well-characterized vancomycin-resistant Enterococcus strains and/or clinical isolates (43 VanA-type and 45 VanB-type) were evaluated with the IMDx VanR for Abbott m2000 assay. All strains were detected by the assay.
- Challenge Study: A challenge study was conducted using a panel of 72 well-characterized strains of Enterococcus: 23 vanA strains, 25 vanB strains, 2 strains with both vanA and vanB genes, 1 strain with both vanA and vanC genes, 5 vanC strains, 3 vanD strains, 1 vanG strains, 1 vanG strain, and 10 vancomycin-susceptible strains. All Enterococcus strains harboring vanA or vanB resistance genes were detected. All Enterococcus strains harboring vanC, vanE, or vanG resistance genes and all vancomycin-sensitive Enterococcus strains were not detected by the IMDx VanR for Abbott m2000 assay.
- Cross-Reactivity/Microbial Interference: The IMDx VanR for Abbott m2000 assay was evaluated for potential cross-reactivity and/or interference using a panel of 96 organisms that may be present in rectal. peri-rectal and stool samples. Included in the panel were 13 vancomycin-sensitive Enterococcus strains and 10 vancomycin-resistant (non-vanAlvanB) Enterococcus strains. Bacteria were tested at a concentration of >= 1 x 10^6 CFU/mL, and viruses at a concentration of >= 1 x 10 TCIDs6/mL. None of the organisms tested were found to cross-react or interfere with the IMDx VanR for Abbott m2000 assay.
- Vancomycin-Resistant Staphylococcus aureus (VRSA) strains: Twelve (12) VRSA (VanA-type) isolates from the Network on Antimicrobial Resistance in Staphylococcus aureus (NARSA) were tested with the IMDx VanR for Abbott m2000 assay. The vanA gene was detected in all strains. The vanB gene was not detected in any of the strains. Since S. aureus may harbor vanA and vanB vancomycin resistance genes, the IMDx VanR for Abbott m2000 assay may produce detected results if S. aureus organisms harboring these genes are present in the clinical specimen.
- Interfering Substances: The IMDx VanR for Abbott m2000 assay was challenged with twenty-three (23) substances that may be present in rectal, peri-rectal or stool specimens. No assay interference was observed for any of the substances.
Clinical Performance Characteristics
- Study type: Comparison to enriched culture combined with confirmation of the molecular basis of vancomycin resistance of isolates using an alternate PCR method.
- Sample size: 587 peri-rectal swabs, 444 rectal swabs, and 469 stool specimens.
- Key Results: Performance data for peri-rectal swabs, rectal swabs (prospective and retrospective collection), and stool specimens are provided in tables.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Peri-rectal Swab Specimens:
- Sensitivity: 94.0% (95% CI: 83.8% - 97.9%)
- Specificity: 93.9% (95% CI: 91.5% - 95.6%)
- Positive Predictive Value: 58.8% (95% CI: 47.8% - 68.9%)
- Negative Predictive Value: 99.4% (95% CI: 98.3% - 99.8%)
- Prevalence: 8.5%
Rectal Swab Specimens (Prospective Collection):
- Sensitivity: 96.8% (95% CI: 89.1% - 99.1%)
- Specificity: 91.7% (95% CI: 88.3% - 94.2%)
- Positive Predictive Value: 68.5% (95% CI: 58.3% - 77.2%)
- Negative Predictive Value: 99.4% (95% CI: 97.7% - 99.8%)
- Prevalence: 15.8%
Rectal Swab Specimens (Retrospective Collection):
- Positive Percent Agreement: 100.0% (95% CI: 91.6% - 100.0%)
- Negative Percent Agreement: 0.0% (95% CI: 0.0% - 65.8%)
Stool Specimens:
- Sensitivity: 87.0% (95% CI: 77.0% - 93.0%)
- Specificity: 85.8% (95% CI: 82.0% - 88.8%)
- Positive Predictive Value: 51.3% (95% CI: 42.3% - 60.2%)
- Negative Predictive Value: 97.4% (95% CI: 95.2% - 98.6%)
- Prevalence: 14.7%
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.
BD GeneOhm™ VanR Assay (K102416)
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
27 IMDx VanR for Abbott m2000 Supplement IMDx Response to FDA Request for Additional Information
510(k) SUMMARY
| Date of Summary: | July 10, 2013 | JUL 17 2013 |
|---|---|---|
| Product Name | IMDx VanR for Abbott m 2000 | |
| Sponsor | Intelligent Medical Devices, Inc. | |
| 19 Blackstone Street | ||
| Cambridge, MA 02139 | ||
| Correspondent | MDC Associates, LLC | |
| Fran White, Regulatory Consultant | ||
| 180 Cabot Street | ||
| Beverly, MA 01915 | ||
| Device Identification | ||
| Trade or Proprietary Name: | ||
| Common or Usual Name: | IMDx VanR for Abbott m 2000 | |
| Vancomycin-resistant enterococci detection assay |
Product Code: NIJ, OOI Regulation Section: 21 CFR 866.1640 Antimicrobial susceptibility test powder Device Class: Class II Panel: 83; Microbiology
Device Description
The IMDx VanR for Abbott m2000 assay is a PCR-based assay that targets regions unique to the vanA and vanB vancomycin resistance genes that may be associated with vancomycin resistant Enterococcus (VRE). Detection of the vanA and vanB genes is measured by the presence of fluorescently-labeled oligonucleotide probes that generate a fluorescent signal when specifically bound to amplified vanA and/or vanB PCR products. Differentiation of vanA from vanB is attained by labeling the oligonucleotide probes with different colored fluorescent dyes. The amplification cycle at which fluorescent signal is detected by the Abbott m2000rt is inversely proportional to the vanA and vanB DNA target level present in the sample.
The IMDx VanR for Abbott m2000 assay includes reagents for the detection of the assay process control, which contains inactivated bacteria, unrelated to enterococci, and is introduced into each specimen during sample preparation. The process control (also acting as an internal control (IC)) is co-extracted with the specimen and co-amplified in the same PCR reaction as the vanA and vanB targets. The IC demonstrates that the entire assay process has proceeded within specification.
Intended Use
The IMDx VanR for Abbott m2000 assay is an in vitro diagnostic assay that uses polymerase chain reaction (PCR) amplification for the qualitative detection of nucleic acids encoding the
1
IMDx Response to FDA Request for Additional Information
vancomycin resistance genes vanA and/or vanB. The assay is performed directly on human perirectal swabs, rectal swabs, or stool specimens from patients at risk for Vancomycin Resistant Enterococcus (VRE) colonization. The IMDx VanR for Abbott m2000 assay detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci. The IMDx VanR for Abbott m2000 assay can be used as an aid to identify. prevent and control vancomycin-resistant colonization in healthcare settings. The IMDx VanR for Abbott m2000 assay is not intended to diagnose VRE infection nor to guide or monitor treatment of infection. Culture methods are necessary to recover organisms for epidemiology typing and confirmation testing.
Substantial Equivalency
The IMDx VanR for Abbott m2000 assay is substantially equivalent to the BD GeneOhm™ VanR Assay (K102416). Table 1 compares the characteristics of the IMDx VanR for m2000 assay (New Device) and the GeneOhm assay (Predicate Device).
| Similarities | ||
|---|---|---|
| Characteristic | Predicate Device | |
| BD GeneOhm VanR Assay | ||
| (K102416) | New Device | |
| IMDx VanR for | ||
| Abbott m2000 | ||
| Intended Use | The BD GeneOhm VanR Assay is a | |
| qualitative in vitro test for the rapid detection | ||
| of vancomycin-resistant ( vanA and vanB ) | ||
| genes directly from perianal or rectal swabs. | ||
| The BD GeneOhm VanR Assay detects the | ||
| presence of the vanA and vanB genes that can | ||
| be associated with vancomycin-resistant | ||
| enterococci (VRE). The assay is performed on | ||
| an automated real-time PCR instrument with | ||
| perianal or rectal swabs from individuals at | ||
| risk for VRE colonization. The BD GeneOhm | ||
| VanR Assay can be used as an aid to identify, | ||
| prevent and control vancomycin-resistant | ||
| colonization in healthcare settings. The BD | ||
| GeneOhm VanR Assay is not intended to | ||
| diagnose VRE infections nor to guide or | ||
| monitor treatment for VRE infections. | ||
| Concomitant cultures are necessary to recover | ||
| organisms for epidemiological, susceptibility | ||
| testing and for further confirmatory | ||
| identification. | The IMDx VanR for Abbott m2000 assay | |
| is an in vitro diagnostic assay that uses | ||
| polymerase chain reaction (PCR) | ||
| amplification for the qualitative detection | ||
| of nucleic acids encoding the vancomycin | ||
| resistance genes vanA and/or vanB . The | ||
| assay is performed directly on human peri- | ||
| rectal swabs, rectal swabs, or stool | ||
| specimens from patients at risk for | ||
| Vancomycin Resistant Enterococcus | ||
| (VRE) colonization. The IMDx VanR for | ||
| Abbott m2000 assay detects the presence | ||
| of vanA and vanB genes that can be | ||
| associated with vancomycin-resistant | ||
| enterococci. The IMDx VanR for Abbott | ||
| m2000 assay can be used as an aid to | ||
| identify, prevent and control vancomycin- | ||
| resistant colonization in healthcare settings. | ||
| The IMDx VanR for Abbott m2000 assay | ||
| is not intended to diagnose VRE infection | ||
| nor to guide or monitor treatment of | ||
| infection. Culture methods are necessary | ||
| to recover organisms for epidemiology | ||
| typing and confirmation testing. | ||
| Sample Type | Perianal or rectal swab specimens | Rectal and peri-rectal swabs |
| or stool specimens | ||
| Test Principle | Real-time PCR DNA amplification | Real-time PCR DNA amplification |
Table 1: Substantial Equivalence.
2
IMDx Response to FDA Request for Additional Information
| Similarities | ||
|---|---|---|
| Characteristic | Predicate Device | |
| BD GeneOhm VanR Assay | ||
| (K102416) | New Device | |
| IMDx VanR for | ||
| Abbott m2000 | ||
| Targets | ||
| Detected | vanA and vanB | vanA and vanB |
| Controls | Positive Control | |
| Negative Control | ||
| Process Control | Positive Control | |
| Negative Control | ||
| Process Control | ||
| Differences | ||
| Characteristic | Predicate Device | |
| BD GeneOhm VanR Assay | ||
| (K102416) | New Device | |
| IMDx VanR for Abbott m2000 | ||
| Instrument | Cepheid SmartCycler System | Abbott m2000 System |
| Sample | ||
| Preparation | Manual | Automated |
The differences between the IMDx VanR for Abbott m2000 assay and the BD GeneOhm VanR Assay do not impact substantial equivalence. Both assays detect vanA and vanB nucleic acids from similar specimen types and have comparable intended uses. The differences noted above do not change the intended use of the IMDx VanR for Abbott m2000 and do not raise questions regarding the safety and effectiveness of the device.
Performance Characteristics Analytical Performance
Precision (Repeatability/Reproducibility)
Assay precision was measured in four independent studies: within laboratory repeatability, userto-user reproducibility, lot-to-lot reproducibility and instrument reproducibility using a seven-member panel consisting of one vanA and one vanB VRE strain at varving concentrations: Positive (2-3X LoD), Low Positive (LoD) and High Negative (vanA
Positive | 3.3% | 3.6% | 0.7% | 1.0% | 0.8% |
| vanA
Low Positive | 3.9% | 4.7% | 2.8% | 1.5% | 1.7% |
Table 2. Precision (%CV) for vanA/vanB based on CN values.
3
IMDx Response to FDA Request for Additional Information
| Precision | Reproducibility | Repeatability | Lot to Lot | Instrument to Instrument | |
|---|---|---|---|---|---|
| vanA | |||||
| High Negative | 3.4% | 3.3% | 3.6% | 3.5% | 2.8% |
| vanB | |||||
| Positive | 2.0% | 2.3% | 0.6% | 1.1% | 0.8% |
| vanB | |||||
| Low Positive | 2.6% | 2.1% | 1.5% | 1.3% | 1.5% |
| vanB | |||||
| High Negative | 3.2% | 2.1% | 1.7% | 2.4% | 2.6% |
| Negative | N/A | N/A | N/A | N/A | N/A |
Table 3. Precision (% Agreement).
| Precision
Panel | Expected
Positivity | Reproducibility | Repeatability | Lot to
Lot | Instrument to
Instrument | |
|--------------------------|------------------------|-----------------|---------------|---------------|-----------------------------|---------|
| Member | | | | | m2000sp | m2000rt |
| vanA
Positive | 100% | 100.0% | 97.2% | 100.0% | 100.0% | 100.0% |
| vanA
Low Positive | 95% | 96.7% | 95.8% | 100.0% | 100.0% | 100.0% |
| vanA
High
Negative | 20 - 80% | 66.7% | 55.6% | 44.4% | 55.6% | 55.6% |
| vanB
Positive | 100% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
| vanB
Low Positive | 95% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
| vanB
High
Negative | 20 - 80% | 35.6% | 27.8% | 55.6% | 16.7% | 27.8% |
| Negative | 0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
Analytical Sensitivity (Limit of Detection)
Limit of Detection (LoD) studies were conducted to determine the lowest concentration of each target analyte that could be detected ≥ 95% of the time. Six strains of vancomycin-resistant Enterococcus, four VanA-type and two VanB-type, were tested. Dilutions of quantified bacterial stocks were tested in replicates of sixty (60). The LoD of the assay was estimated using probit analysis for each target (vanA and vanB). The observed LoD for VRE strains tested is provided in Table 4.
4
IMDx Response to FDA Request for Additional Information
| Strain | Genotype | Limit of Detection (95% CI) |
|---|---|---|
| E. faecium ATCC 51559 | vanA | 1010.7 CFU/swab (975.1 - 1047.5) |
| E. faecium ATCC 700221 | vanA | 4300.6 CFU/swab (3862.6 - 4788.2) |
| E. faecium ATCC BAA-2318 | vanA | 889.0 CFU/swab (777.1 - 1017.0) |
| E. faecium ATCC BAA-2320 | vanA | 2435.4 CFU/swab (2043.9–2901.7) |
| E. faecalis ATCC 51575 | vanB | 810.1 CFU/swab (571.7-1147.8) |
| E. faecalis ATCC 700802 | vanB | 1610.0 CFU/swab (1569.1 – 1652.0) |
Table 4. Limit of Detection
Analytical Reactivity
Eighty-eight (88) well-characterized vancomycin-resistant Enterococcus strains and/or clinical isolates (43 VanA-type and 45 VanB-type) were evaluated with the IMDx VanR for Abbott m2000 assay. All strains were detected by the assay.
Challenge Study
A challenge study was conducted using a panel of 72 well-characterized strains of Enterococcus: 23 vanA strains, 25 vanB strains, 2 strains with both vanA and vanB genes, 1 strain with both vanA and vanC genes, 5 vanC strains, 3 vanD strains, 1 vanG strains, 1 vanG strain, and 10 vancomycin-susceptible strains. All Enterococcus strains harboring vanA or vanB resistance genes were detected. All Enterococcus strains harboring vanC, vanE, or vanG resistance genes and all vancomycin-sensitive Enterococcus strains were not detected by the IMDx VanR for Abbott m2000 assay.
Cross-Reactivity/Microbial Interference
The IMDx VanR for Abbott m2000 assay was evaluated for potential cross-reactivity and/or interference using a panel of 96 organisms that may be present in rectal. peri-rectal and stool samples. Included in the panel were 13 vancomycin-sensitive Enterococcus strains and 10 vancomycin-resistant (non-vanAlvanB) Enterococcus strains. Bacteria were tested at a concentration of ≥ 1 x 106 CFU/mL, and viruses at a concentration of ≥ 1 x 10 TCIDs6/mL. None of the organisms tested were found to cross-react or interfere with the IMDx VanR for Abbott m2000 assay.
Vancomycin-Resistant Staphylococcus aureus (VRSA) strains
Twelve (12) VRSA (VanA-type) isolates from the Network on Antimicrobial Resistance in Staphylococcus aureus (NARSA) were tested with the IMDx VanR for Abbott m2000 assay. The vanA gene was detected in all strains. The vanB gene was not detected in any of the strains. Since S. aureus may harbor vanA and vanB vancomycin resistance genes, the IMDx VanR for Abbott m2000 assay may produce detected results if S. aureus organisms harboring these genes are present in the clinical specimen.
5
Interfering Substances
The IMDx VanR for Abbott m2000 assay was challenged with twenty-three (23) substances that may be present in rectal, peri-rectal or stool specimens. The substances included: anti-fungal/ anti-itch vaginal cream, suppositories, anti-hemorrhoid creams/ointments, antacids, enemas. condoms with spermicidal lubricant, anti-diarrheal medication, laxatives, antibiotics (oral and topical), non-steroidal anti-inflammatory medications, moist towelettes, fecal components (e.g. blood, mucus, fecal lipid), and MRI contrast agent. No assay interference was observed for any of the substances.
Clinical Performance Characteristics
The performance of the IMDx VanR for Abbott m2000 assay was assessed by comparison to enriched culture combined with confirmation of the molecular basis of vancomycin resistance of isolates using an alternate PCR method. Samples were collected from five geographically diverse test sites within the United States. The patient distribution, by age, is shown in Figure 1. Samples enrolled for this study included a total of 587 peri-rectal swabs. 444 rectal swabs, and 469 stool specimens. Assay performance, by specimen type, is listed in Tables 5-10. Tables 11-12 presents Assay performance by genotype detected.
Image /page/5/Figure/5 description: The image is a bar graph showing the number of subjects versus patient age in years. The x-axis shows the patient age in years, broken down into groups such as less than or equal to 10, 11-20, 21-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90, and greater than or equal to 91. The y-axis shows the number of subjects, ranging from 0 to 300. The number of subjects is highest in the 61-70 age range, with approximately 275 subjects.
Image /page/5/Figure/6 description: The image shows the title of a figure and a description of the patient population. The title of the figure is "Figure 1. Patient Population." The description states that the subjects ranged in age from less than 1 to 98 years old.
6
| Enriched Culture + Alternative PCR | ||||||
|---|---|---|---|---|---|---|
| VanA-type | ||||||
| Enterococcus | VanB-type | |||||
| Enterococcus | VanA-type and | |||||
| VanB-type | ||||||
| Enterococcus | Negative | Total | ||||
| IMDx VanR | ||||||
| for Abbott | ||||||
| m2000 | vanA | 38 | 0 | 0 | 14 | 52 |
| vanB | 0 | 0 | 0 | 15 | 15 | |
| vanA and vanB | 9 | 0 | 0 | 4 | 13 | |
| Not Detected | 3 | 0 | 0 | 504 | 507 | |
| Total | 50 | 0 | 0 | 537 | 587 |
Table 5. Peri-rectal Swab Specimens: IMDx vs. Enriched Culture and Alternative PCR.
Resulting Truth Table for Peri-rectal Swab Specimens: IMDx vs. Enriched Table 6. Culture and Alternative PCR.
| Enriched Culture + Alternative PCR | |||||
|---|---|---|---|---|---|
| POS | NEG | Total | |||
| IMDx VanR | |||||
| for Abbott | |||||
| m2000 | POS | 47 | 33 | 80 | |
| NEG | 3 | 504 | 507 | ||
| Total | 50 | 537 | 587 |
| 95% CI | |
|---|---|
| Sensitivity | 94.0% (83.8% - 97.9%) |
| Specificity | 93.9% (91.5% - 95.6%) |
| Positive Predictive Value | 58.8% (47.8% - 68.9%) |
| Negative Predictive Value | 99.4% (98.3% - 99.8%) |
| Prevalence | 8.5% |
Table 7. Rectal Swab Specimens (Prospective Collection): IMDx vs. Enriched Culture and Alternative PCR.
| | | VanA-type
Enterococcus | VanB-type
Enterococcus | VanA-type and
VanB-type
Enterococcus | Negative | Total |
|----------------------------------|---------------|-----------------------------------------|-----------------------------------------|-----------------------------------------------------------------|----------|-------|
| IMDx VanR
for Abbott
m2000 | vanA | 51 | 0 | 0 | 11 | 62 |
| | vanB | 0 | 0 | 0 | 16 | 16 |
| | vanA and vanB | 9 | 1 | 0 | 1 | 11 |
| | Not Detected | 2 | 0 | 0 | 309 | 311 |
| | Total | 62 | 1 | 0 | 337 | 400 |
Enriched Culture + Alternative PCR
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IMDx Response to FDA Request for Additional Information
Table 8. Resulting Truth Table from Rectal Swab Specimens (Prospective Collection): IMDx vs. Enriched Culture and Alternative PCR.
| Enriched Culture + Alternative PCR | ||||
|---|---|---|---|---|
| POS | NEG | Total | ||
| IMDx VanR | ||||
| for Abbott | ||||
| m2000 | POS | 61 | 28 | 89 |
| NEG | 2 | 309 | 311 | |
| Total | 63 | 337 | 400 |
| 95% CI | |
|---|---|
| Sensitivity | 96.8% (89.1% - 99.1%) |
| Specificity | 91.7% (88.3% - 94.2%) |
| Positive Predictive Value | 68.5% (58.3% - 77.2%) |
| Negative Predictive Value | 99.4% (97.7% - 99.8%) |
| Prevalence | 15.8% |
Table 9. Rectal Swab Specimens (Retrospective Collection): IMDx vs. Enriched Culture and Alternative PCR.
| Enriched Culture + Alternative PCR | ||||||
|---|---|---|---|---|---|---|
| VanA-type | ||||||
| Enterococcus | VanB-type | |||||
| Enterococcus | VanA-type and | |||||
| VanB-type | ||||||
| Enterococcus | Negative | Total | ||||
| vanA | 30 | 0 | 0 | 2 | 32 | |
| IMDx VanR | ||||||
| for Abbott | ||||||
| m2000 | vanB | 0 | 0 | 0 | 0 | 0 |
| vanA and vanB | 12 | 0 | 0 | 0 | 12 | |
| Not Detected | 0 | 0 | 0 | 0 | 0 | |
| Total | 42 | 0 | 0 | 2 | 44 |
E-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Table 10. Resulting Truth Table from Rectal Swab Specimens (Retrospective Collection): IMDx vs. Enriched Culture and Alternative PCR.
| Enriched Culture + Alternative PCR | ||||
|---|---|---|---|---|
| POS | NEG | Total | ||
| IMDx VanR | ||||
| for Abbott | ||||
| m2000 | POS | 42 | 2 | 44 |
| NEG | 0 | 0 | 0 | |
| Total | 42 | 2 | 44 |
8
IMDx Response to FDA Request for Additional Information
| 95% CI | ||
|---|---|---|
| Positive Percent Agreement | 100.0% | (91.6% - 100.0%) |
| Negative Percent Agreement | 0.0% | (0.0% - 65.8%) |
Table 11. Stool Specimens: IMDx vs. Enriched Culture and Alternative PCR.
| | | VanA -type
Enterococcus | VanB -type
Enterococcus | VanA -type and
VanB -type
Enterococcus | Negative | Total |
|----------------------------------|-----------------------------|------------------------------------------|------------------------------------------|-------------------------------------------------------------------|----------|-------|
| IMDx VanR
for Abbott
m2000 | vanA | 50 | 0 | 0 | 7 | 57 |
| | vanB | 2* | 0 | 0 | 45 | 47 |
| | vanA and vanB | .9 | 0 | 1 | 5 | 15 |
| | Not Detected | 7 | 0 | 0 | 343 | 350 |
| | Total | 68 | 0 | 1 | 400 | 469 |
Enriched Culture + Alternative PCR
- Considered as a false negative result for the 2x2 table below
Table 12. Resulting Truth Table from Stool Specimens: IMDx vs. Enriched Culture and Alternative PCR.
| Enriched Culture + Alternative PCR | ||||
|---|---|---|---|---|
| IMDx VanR | ||||
| for Abbott | ||||
| m2000 | POS | NEG | Total | |
| POS | 60 | 57 | 117 | |
| NEG | 9 | 343 | 352 | |
| Total | 69 | 400 | 469 |
| 95% CI | |
|---|---|
| Sensitivity | 87.0% (77.0% - 93.0%) |
| Specificity | 85.8% (82.0% - 88.8%) |
| Positive Predictive Value | 51.3% (42.3% - 60.2%) |
| Negative Predictive Value | 97.4% (95.2% - 98.6%) |
| Prevalence | 14.7% |
Conclusions
.
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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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
INTELLIGENT MEDICAL DEVICES, INC. C/O FRAN WHITE REGULATORY CONSULTANT MDC ASSOCIATES 180 CABOT STREET BEVERLY MA 01915
July 17, 2013
Re: K123753
Trade/Device Name: IMDx VanR for Abbott m2000 Assay Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: NIJ, OOI Dated: June 13, 2013 Received: June 14, 2013
Dear Ms. White:
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-Ms. White
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 80) and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Uwe Scherf -S (or
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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Indications for Use
K123753 510(k) Number:
Device Name:
IMDx VanR for Abbott m2000
Indications for Use:
The IMDx VanR for Abbott m2000 assay is an in vitro diagnostic assay that uses polymerase chain reaction (PCR) amplification for the qualitative detection of nucleic acids encoding the vancomycin resistance genes vanA and/or vanB. The assay is performed directly on human perirectal swabs, rectal swabs, or stool specimens from patients at risk for Vancomycin-Resistant Enterococcus (VRE) colonization. The IMDx VanR for Abbott m2000 assay detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci. The IMDx VanR for Abbott m2000 assay can be used as an aid to identify, prevent and control vancomycin-resistant colonization in healthcare settings. The IMDx VanR for Abbott m2000 assay is not intended to diagnose VRE infection nor to guide or monitor treatment of infection. Culture methods are necessary to recover organisms for epidemiology typing and confirmation testing.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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