Who is the manufacturer of IMDX VANR FOR ABBOTT M2000?

Intelligent Medical Devices, Inc. filed the 510(k) submission for IMDX VANR FOR ABBOTT M2000 (K123753).

What is the FDA product code for IMDX VANR FOR ABBOTT M2000?

NIJ. It is classified under 21 CFR 866.1640 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for IMDX VANR FOR ABBOTT M2000?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like IMDX VANR FOR ABBOTT M2000?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IMDX VANR FOR ABBOTT M2000

K123753 · Intelligent Medical Devices, Inc. · NIJ · Jul 17, 2013 · Microbiology

Device Facts

Record ID	K123753
Device Name	IMDX VANR FOR ABBOTT M2000
Applicant	Intelligent Medical Devices, Inc.
Product Code	NIJ · Microbiology
Decision Date	Jul 17, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.1640
Device Class	Class 2

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 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.

Device Story

The IMDx VanR for Abbott m2000 is a qualitative real-time PCR assay for detecting vanA and vanB genes. It uses the Abbott m2000sp for automated sample preparation (lysis, extraction) and the Abbott m2000rt for amplification and detection. The system uses fluorescently-labeled oligonucleotide probes to distinguish vanA and vanB targets. An internal process control (inactivated bacteria) is co-extracted and co-amplified to ensure assay integrity. The device is used in clinical laboratories by trained personnel. The Abbott m2000rt software interprets fluorescence data to provide a qualitative result (Detected/Not Detected). Results aid healthcare providers in identifying and controlling VRE colonization in healthcare settings. It does not diagnose active infection or guide treatment.

Clinical Evidence

Clinical performance evaluated at five US sites using 1,500 prospective specimens (stool, rectal, peri-rectal) compared to enriched culture plus alternative PCR. Sensitivity ranged from 87.0% (stool) to 96.8% (rectal swab). Specificity ranged from 85.8% (stool) to 93.9% (peri-rectal). NPV was high (97.4%–99.4%). Retrospective study of 44 rectal swabs showed 100% PPA. Bench testing included precision, LoD, analytical reactivity (91 strains), and cross-reactivity (96 organisms).

Technological Characteristics

Real-time PCR assay; fluorescently-labeled oligonucleotide probes; automated sample preparation and amplification on Abbott m2000 system. Targets vanA and vanB genes. Includes internal process control (inactivated bacteria).

Indications for Use

Indicated for qualitative detection of vanA and/or vanB genes associated with VRE in patients at risk for colonization. Specimens: peri-rectal swabs, rectal swabs, or stool. Not for VRE infection diagnosis or treatment monitoring.

Regulatory Classification

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.

Predicate Devices

BD GeneOhm™ VanR Assay (K102416)

Related Devices

K102416 — BD GENEOHM VANR ASSAY · Bd Diagnostics Science · Oct 20, 2011
K061686 — IDI-VANR ASSAY · Geneohm Sciences Canada, Inc. · Aug 30, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ K123753 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 (<1X LoD). The final panel member was a true negative sample (negative specimen matrix alone). Table 2 lists %CV values for precision studies. Table 3 lists % agreement values for precision studies. | Precision Panel Member | Reproducibility | Repeatability | Lot to Lot | Instrument to Instrument | | |-----------------------------|-----------------|---------------|------------|--------------------------|------| | 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 {7}------------------------------------------------ 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. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". #### 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. {10}------------------------------------------------ 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 {11}------------------------------------------------ #### 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) Image /page/11/Picture/10 description: The image shows the text "John Hobson-S" at the top, followed by "2013.07.16" and "13:11:52-04'00'". The text is overlaid on a patterned background that includes the letters "FDA" in a triangular shape. The text appears to be a timestamp or record of some kind, possibly related to the FDA.

IMDX VANR FOR ABBOTT M2000

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