(106 days)
Not Found
No
The device description and performance studies focus on PCR technology and standard analytical methods, with no mention of AI or ML.
No
This device is an in vitro diagnostic test used to detect and differentiate between types of herpes simplex virus, aiding in diagnosis, not providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states the device is an "in vitro diagnostic test".
No
The device is an in vitro diagnostic test that uses PCR and fluorescent probes to detect and differentiate HSV DNA. It is intended to be run on the Abbott m2000 instrument system, which is a hardware platform. The description details reagents, controls, and the physical process of amplification and detection, indicating it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in vitro diagnostic test" and is intended for "qualitative detection and differentiation of herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) DNA from male and female skin lesions from anogenital or oral sites." This clearly indicates it is used to test samples taken from the human body outside of the body to aid in diagnosis.
- Device Description: The description details the use of PCR and fluorescent probes to detect and differentiate HSV DNA in clinical specimens. This is a common method used in IVD tests.
- Performance Studies: The document includes detailed descriptions of prospective and retrospective clinical studies, as well as analytical performance characteristics like sensitivity, specificity, precision, cross-reactivity, and limit of detection. These types of studies are conducted to demonstrate the performance of an IVD device.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K100336) is a strong indicator that this device is being compared to a previously cleared IVD device, which is a standard process for regulatory submission of IVDs.
All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMDx HSV-1/2 for Abbott m2000 assay is an in vitro diagnostic test for the direct, qualitative detection and differentiation of herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) DNA from male and female skin lesions from anogenital or oral sites. The test is intended for use as an aid in the diagnosis of HSV infection in symptomatic patients. The assay is intended to be run on the Abbott m2000 instrument system.
Warning: The IMDx HSV-1/2 for Abbott m2000 assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended for prenatal screening.
Product codes
OQO
Device Description
The IMDx FISV-1/2 for Abbott m2000 assay uses PCR to generate amplified product from HSV-1 and HSV-2 present in clinical specimens. The presence of HSV-1 and/or HSV-2 target DNA is indicated by the fluorescent signal generated through the use of fluorescently labeled oligonucleotide probes on the Abbott m2000rt instrument. The probes do not generate a signal unless they are specifically bound to the amplified product. The amplification cycle at which fluorescent signal is detected by the Abbott m2000rt is inversely proportional to the HSV-1 and/or HSV-2 DNA target concentration present in the original specimen. A plasmid containing DNA unrelated to HSV-1 and HSV-2 is introduced into each specimen during sample preparation to serve as an internal control. The internal control is amplified in the same reaction as the HSV-1 and HSV-2 DNA targets, and serves to demonstrate that the sample preparation and amplification proceeded correctly for each specimen. A preparation of intact, inactivated HSV-1 and HSV-2 virus is included as the positive control in the IMDx HSV-1/2 for Abbott m2000 assay. Run as a separate control, the positive control serves to demonstrate that the HSV-1/2 PCR reagents are functional. In addition, the positive control functions as a process control to demonstrate that sample preparation has proceeded correctly during the run. A negative control consisting of M4RT viral transport medium is included in each run to independently verify the absence of contaminating target material in assay reagents.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
male and female skin lesions from anogenital or oral sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Description of the test set, sample size, data source, and annotation protocol:
A total of 954 prospective specimens (807 anogenital and 147 oral) were included in the final data set and analyzed for product performance as compared to results obtained from the ELVIS® (Enzyme Linked Virus Inducible System) HSV ID and D3 Typing Test System (Diagnostic Hybrids, Athens, OH).
161 anogenital prospective specimens identified as HSV-2 positive by ELVIS viral culture were removed from the initial 807 anogenital specimens for the calculation of the HSV-1 clinical performance. Two oral specimens identified as HSV-2 positive by ELVIS viral culture were removed from the initial 147 oral specimens for the calculation of the HSV-1 clinical performance.
A total of 54 retrospective specimens (27 anogenital and 27 oral) were tested with the IMDx HSV-1/2 for Abbott m2000 assay and results were compared to historical results for the ELVIS® HSV ID and D3 Typing Test System. Twelve (12) anogenital specimens identified as HSV-2 positive by ELVIS viral culture were removed from the initial 27 anogenital specimens for the calculation of the HSV-1 clinical performance. There was no HSV-2 positive detected in 27 oral specimens.
A contrived specimen study was performed to provide additional performance data for detection of HSV-2 in oral samples. HSV-negative oral samples (culture negative and PCR negative) used for the contrived study were remainders from the clinical specimens used for the method comparison study. Thirty (30) contrived HSV-2 positive oral samples were prepared by spiking HSV-2 virus into HSV-negative oral samples. HSV-2 virus was spiked in HSV-negative oral samples at concentrations 2-3X LoD, 10X LoD, 100X LoD, 1,000X LoD and 10,000X LoD. In addition. fifteen (15) HSV-1 true positive oral and fifteen (15) HSV-negative oral samples remaining from the clinical specimens used for the method comparison study were also tested. All samples were randomized and blinded to the operator prior to testing.
Summary of Performance Studies
Prospective Studies:
- HSV-1 Results for Anogenital Specimens:
- Sample Size: 646 total (102 POS, 544 NEG by Reference Method)
- Sensitivity: 99.0% (101/102) [95% CI: 94.7%-99.8%]
- Specificity: 96.3% (524/544) [95% CI: 94.4%-97.6%]
- HSV-2 Results for Anogenital Specimens:
- Sample Size: 807 total (161 POS, 646 NEG by Reference Method)
- Sensitivity: 97.5% (157/161) [95% CI: 93.8% - 99.0%]
- Specificity: 89.5% (578/646) [95% CI: 86.9% - 91.6%]
- HSV-1 Results for Oral Specimens:
- Sample Size: 145 total (37 POS, 108 NEG by Reference Method)
- Sensitivity: 100.0% (37/37) [95% CI: 90.6% - 100.0%]
- Specificity: 77.8% (84/108) [95% CI: 69.1% - 84.6%]
- HSV-2 Results for Oral Specimens:
- Sample Size: 147 total (2 POS, 145 NEG by Reference Method)
- Sensitivity: 0.0% (0/2) [95% CI: 0.0% - 65.8%]
- Specificity: 98.6% (143/145) [95% CI: 95.1% - 99.6%]
Retrospective Studies:
- HSV-1 Results for Anogenital Specimens:
- Sample Size: 15 total (15 POS by Reference Method)
- Sensitivity: 93.3% (14/15) [95% CI: 70.2% - 98.8%]
- Specificity: N/A
- HSV-2 Results for Anogenital Specimens:
- Sample Size: 27 total (12 POS, 15 NEG by Reference Method)
- Sensitivity: 100.0% (12/12) [95% CI: 75.7 - 100.0%]
- Specificity: 93.3% (14/15) [95% CI: 70.2% - 98.8%]
- HSV-1 Results for Oral Specimens:
- Sample Size: 27 total (27 POS, 0 NEG by Reference Method)
- Sensitivity: 100.0% (27/27) [95% CI: 87.5% - 100.0%]
- Specificity: N/A
- HSV-2 Results for Oral Specimens:
- Sample Size: 27 total (0 POS, 27 NEG by Reference Method)
- Sensitivity: N/A
- Specificity: 100.0% (27/27) [95% CI: 87.5% - 100.0%]
HSV-2 Oral Contrived Specimen Study:
- HSV-2 was detected in all contrived samples at all concentrations tested (2-3X LoD, 10X LoD, 100X LoD, 1,000X LoD and 10,000X LoD).
Analytical Performance Characteristics:
- Precision/Reproducibility:
- Within Laboratory Repeatability (Sample Size: 72 replicates per panel member):
- HSV-1 Positive (2-3X LoD): 100.00% agreement (72/72)
- HSV-1 Low Positive (~1X LoD): 100.00% agreement (72/72)
- HSV-1 High Negative (
- Within Laboratory Repeatability (Sample Size: 72 replicates per panel member):
§ 866.3305 Herpes simplex virus serological assays.
(a)
Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.(b)
Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
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510(k) Summary
| Product Name | IMDx HSV-1/2 for Abbott m2000 |
|---|---|
| Sponsor | Intelligent Medical Devices, Inc. |
| 285 Bear Hill Road | |
| Waltham, MA 02451 | |
| Correspondent | MDC Associates, LLC |
| Fran White, Regulatory Consultant | |
| 180 Cabot Street | |
| Beverly, MA 01915 | |
| Device Identification | |
| Trade or Proprietary Name: | IMDx HSV-1/2 for Abbott m2000 |
| Common or Usual Name: | HSV-1/2 assay |
| Product Code: | OQO |
| Regulation Section: | 21 CFR 866.3305 |
Class II
Intended Use
Regulation Section: Product Classification:
The IMDx HSV-1/2 for Abbott m2000 assay is an in vitro diagnostic test for the direct, qualitative detection and differentiation of herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) DNA from male and female skin lesions from anogenital or oral sites. The test is intended for use as an aid in the diagnosis of HSV infection in symptomatic patients. The assay is intended to be run on the Abbott m2000 instrument system.
Warning: The IMDx HSV-1/2 for Abbott m2000 assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended for prenatal screening.
Device Description
The IMDx FISV-1/2 for Abbott m2000 assay uses PCR to generate amplified product from HSV-1 and HSV-2 present in clinical specimens. The presence of HSV-1 and/or HSV-2 target DNA is indicated by the fluorescent signal generated through the use of fluorescently labeled oligonucleotide probes on the Abbott m2000rt instrument. The probes do not generate a signal unless they are specifically bound to the amplified product. The amplification cycle at which fluorescent signal is detected by the Abbott m2000rt is inversely proportional to the HSV-1 and/or HSV-2 DNA target concentration present in the original specimen. A plasmid containing DNA unrelated to HSV-1 and HSV-2 is introduced into each specimen during sample preparation to serve as an internal control. The internal control is amplified in the same reaction as the HSV-1 and HSV-2 DNA targets, and serves to demonstrate that the sample preparation and amplification proceeded correctly for each specimen. A preparation of intact, inactivated HSV-1 and HSV-2 virus is included as the positive control in the IMDx HSV-1/2 for Abbott m2000 assay. Run as a separate control, the positive control serves to demonstrate that the HSV-1/2 PCR reagents are functional. In addition, the positive control functions as
1
a process control to demonstrate that sample preparation has proceeded correctly during the run. A negative control consisting of M4RT viral transport medium is included in each run to independently verify the absence of contaminating target material in assay reagents.
Substantial Equivalency
The IMDx HSV-1/2 for Abbott m2000 is substantially equivalent to the Eragen Bioscience, Inc MultiCode® RTx Herpes Simplex Virus 1 & 2 Kit. (K100336). Table 1 compares the characteristics of the IMDx HSV-1/2 for Abbott m2000 assay (New Device) and the MultiCode® RTx Herpes Simplex Virus 1 & 2 Kit (Predicate Device). The differences noted do not impact the intended use and do not raise questions as to the safety and effectiveness of the test (new) device.
| Similarities | ||
|---|---|---|
| Characteristic | Eragen Biosciences MultiCode®- | |
| RTx Herpes Simplex Virus 1 & 2 | ||
| Kit | IMDx HSV-1/2 for | |
| Abbott m2000 Assay | ||
| (New Device) | ||
| 510(k) | K100336 | TBD |
| Regulation | 21 CFR 866.3305 | 21 CFR 866.3305 |
| Product Code | OQO | OQO |
| Device Class | Class II | Class II |
| Intended use | The MultiCode®-RTx Herpes Simplex | |
| Virus 1 & 2 Kit is a polymerase chain | ||
| reaction (PCR)-based qualitative in | ||
| vitro diagnostic test for the detection | ||
| and typing of herpes simplex virus | ||
| (HSV.1&2) DNA in vaginal lesions. It | ||
| is indicated for use in the detection and | ||
| typing of HSV-1 or HSV-2 in vaginal | ||
| lesion swab specimens from | ||
| symptomatic female patients as an aid | ||
| in the diagnosis of genital herpes | ||
| infection. |
Warning: The device is not FDA
cleared for the use with cerebral spinal
fluid (CSF) or any lesions other than
vaginal. The assay is not intended to be
used for male penile specimens, for
prenatal screening, or females under the
age of 18 years. | The IMDx HSV-1/2 for Abbott m2000 assay
is an in vitro diagnostic test for the direct,
qualitative detection and differentiation of
Herpes Simplex Virus type 1 (HSV-1) and
type 2 (HSV-2) DNA from male and female
skin lesions from anogenital or oral sites.
The test is intended for use as an aid in the
diagnosis of HSV infection in symptomatic
patients. The assay is intended to be run on
the Abbott m2000 instrument system.
Warning: The IMDx HSV-1/2 for Abbott
m2000 assay is not FDA-cleared for use with
cerebrospinal fluid (CSF). The assay is not
intended for pre-natal screening. |
| Test Principle | Real-time PCR DNA amplification | Real-time PCR DNA amplification |
| Assay Results | Qualitative detection and
differentiation of HSV-1 and HSV-2 | Qualitative detection and differentiation of
HSV-1 and HSV-2 |
Table 1. Substantial Equivalence
2
| Differences | ||
|---|---|---|
| Characteristic | Eragen Biosciences MultiCode®- | |
| RTx Herpes Simplex Virus 1 & 2 | ||
| Kit | IMDx HSV-1/2 for | |
| Abbott m2000 Assay | ||
| (New Device) | ||
| Instrumentation | Sample extraction using Roche MagNA | |
| Pure System or bioMérieux NucliSENS | ||
| system. Real-time PCR amplification/ | ||
| detection using the Roche LightCycler | ||
| 1.2 instrument. | Sample extraction and real-time PCR | |
| amplification/detection using the Abbott | ||
| m2000 system. | ||
| Detection | ||
| Method | Pairs fluorescent-labeled primers with | |
| quencher labeled nucleotides. Measures | ||
| decrease in assay fluorescence with | ||
| each PCR cycle. | Double-labeled (fluorophore and quencher) | |
| hydrolysis probes. Measures increase in | ||
| assay fluorescence with each PCR cycle. | ||
| Sample type | Female vaginal lesions | Male and female skin lesions from |
| anogenital or oral sites |
Performance Characteristics
Clinical Performance Characteristics
Prospective Studies: The performance of the IMDx HSV-1/2 for Abbott m2000 assay was evaluated at four geographically diverse locations within the United States from 2012 to 2013. A total of 954 prospective specimens (807 anogenital and 147 oral) were included in the final data set and analyzed for product performance as compared to results obtained from the ELVIS® (Enzyme Linked Virus Inducible System) HSV ID and D3 Typing Test System (Diagnostic Hybrids, Athens, OH).
One hundred and sixty one (161) anogenital prospective specimens identified as HSV-2 positive by ELVIS viral culture were removed from the initial 807 anogenital specimens for the calculation of the HSV-1 clinical performance. Two oral specimens identified as HSV-2 positive by ELVIS viral culture were removed from the initial 147 oral specimens for the calculation of the HSV-1 clinical performance.
| HSV-1 | Reference Method | |||
|---|---|---|---|---|
| POS | NEG | Total | ||
| IMDx | POS | 101 | 20a | 121 |
| NEG | 1b | 524 | 525 | |
| Total | 102 | 544 | 646 | |
| Sensitivity; 95% CI | 99.0% (101/102) 95% CI [94.7%-99.8%] | |||
| Specificity; 95% CI | 96.3% (524/544) 95% CI [94.4%-97.6%] |
Table 2. Summary of HSV-1 Results for Anogenital Specimens (Prospective Study)
a Discordant analysis was performed for 17 of the 20 specimens identified as HSV-1 positive by the IMDx HSV-1/2 for Abbott m2000 assay. HSV-1 was detected in 6 of the 17 specimens. The remaining 11 specimens remained discordant (HSV-1 was not detected).
b Discordant analysis was performed for the single specimen identified as HSV-1 negative by the IMDx HSV-1/2 for Abbott m2000 assay. HSV-1 was not detected in this specimen and HSV-2 was detected in this specimen.
3
| HSV-2 | ELVIS HSV ID and D3 Typing | |||
|---|---|---|---|---|
| POS | NEG | Total | ||
| IMDx | POS | 157 | 68a | 225 |
| NEG | 4b | 578 | 582 | |
| Total | 161 | 646 | 807 | |
| Sensitivity; 95% CI | 97.5% (157/161) 95% CI [93.8% - 99.0%] | |||
| Specificity; 95% CI | 89.5% (578/646) 95% CI [86.9% - 91.6%] |
Table 3. Summary of HSV-2 Results for Anogenital Specimens (Prospective Study)
4 Discordant analysis was performed for 62 of the 68 specimens identified as HSV-2 positive by the IMDx HSV-1/2 for Abbott m2000 assay. HSV-2 was detected in 55 of the 62 specimens. The remaining 7 specimens remained discordant (HSV-2 was not detected).
o Discordant analysis was performed for 2 of the 4 specimens identified as HSV-2 negative by the IMDx HSV-1/2 for Abbott m2000 assay. FISV-2 was not detected in either specimen.
| HSV-1 | Reference Method | |||
|---|---|---|---|---|
| POS | NEG | Total | ||
| IMDx | POS | 37 | 24a | 61 |
| NEG | 0 | 84 | 84 | |
| Total | 37 | 108 | 145 | |
| Sensitivity; 95% CI | 100.0% (37/37) 95% CI [90.6% - 100.0%] | |||
| Specificity; 95% CI | 77.8% (84/108) 95% CI [69.1% - 84.6%] |
Table 4. Summary of HSV-1 Results for Oral Specimens (Prospective Study)
4 Discordant analysis was performed for the 24 specimens identified as HSV-1 positive by the IMDx HSV-1/2 for Abbott m2000 assay. HSV-1 was detected in 14 of the 24 specimens. The remaining 10 specimens remained discordant (HSV-1 was not detected).
| HSV-2 | Reference Method | |||
|---|---|---|---|---|
| POS | NEG | Total | ||
| IMDx | POS | 0 | 2a | 2 |
| NEG | 2b | 143 | 145 | |
| Total | 2 | 145 | 147 | |
| Sensitivity; 95% CI | 0.0% (0/2) 95% CI [0.0% - 65.8%] | |||
| Specificity; 95% CI | 98.6% (143/145) 95% CI [95.1% - 99.6%] |
Table 5. Summary of HSV-2 Results for Oral Specimens (Prospective Study)
4 Discordant analysis was performed for the 2 specimens identified as HSV-2 positive by the IMDx HSV-1/2 for Abbott m2000 assay. HSV-2 was detected in both specimens.
b Discordant analysis was performed for the 2 specimens identified as HSV-2 negative by the IMDx HSV-1/2 for Abbott m2000 assay. HSV-2 was not detected in either specimen. HSV-1 was detected in both specimens.
Retrospective Studies: A total of 54 retrospective specimens (27 anogenital and 27 oral) were tested with the IMDx HSV-1/2 for Abbott m2000 assay and results were compared to historical results for the ELVIS® HSV ID and D3 Typing Test System. Twelve (12) anogenital specimens identified as HSV-2 positive by ELVIS viral culture were removed from the initial 27 anogenital specimens for the calculation of the HSV-1 clinical performance. There was no HSV-2 positive detected in 27 oral specimens.
4
| HSV-I | Reference Method | |||
|---|---|---|---|---|
| POS | NEG | Total | ||
| POS | 14 | 0 | ] 4 | |
| IMDx | NEG | () | ||
| Total | 15 | () | 15 | |
| Sensitivity; 95% CI | 93.3% (14/15) 95% CI [70.2% - 98.8%] | |||
| Specificity; 95% CI | N/A |
Table 6. Summary of HSV-1 Results for Anogenital Specimens (Retrospective Study)
| HSV-2 | Reference Method | ||||
|---|---|---|---|---|---|
| POS | NEG | Total | |||
| POS | 12 | 13 | |||
| IMDx | NEG | 0 | 4 | 14 | |
| Total | 12 | 15 | 27 | ||
| Sensitivity; 95% CI | 100.0% (12/12) 95% CI [75.7 - 100.0% | ||||
| Specificity; 95% Cl | 93.3% (14/15) 95% CI 70.2% - 98.8%] |
Table 8. Summary of HSV-1 Results for Oral Specimens (Retrospective Study)
| HSV-1 | Reference Method | |||
|---|---|---|---|---|
| POS | NEG | Total | ||
| IMDx | POS | 27 | 0 | 27 |
| NEG | 0 | 0 | 0 | |
| Total | 27 | 0 | 27 | |
| Sensitivity; 95% CI | 100.0% (27/27) 95% CI [87.5% - 100.0%] | |||
| Specificity; 95% CI | N/A |
| HSV-2 PCR | HSV-2 Culture | ||||
|---|---|---|---|---|---|
| Positive | Negative | Positive | Negative | ||
| Oral Swabs | Number | 1 | 10 | 0 | 11 |
| Percent | 9.1% | 90.9% | 0% | 100% |
| HSV-2 | Reference Method | |||
|---|---|---|---|---|
| POS | NEG | Total | ||
| IMDx | POS | 0 | 0 | 0 |
| NEG | 0 | 27 | 0 | |
| Total | 0 | 27 | 27 | |
| Sensitivity; 95% CI | N/A | |||
| Specificity; 95% CI | 100.0% (27/27) 95% CI [87.5% - 100.0%] |
HSV-2 Oral Contrived Specimen Study: A contrived specimen study was performed to provide additional performance data for detection of HSV-2 in oral samples. HSV-negative oral samples (culture negative and PCR negative) used for the contrived study were remainders from the clinical specimens used for the method comparison study. Thirty (30) contrived HSV-2 positive oral samples were prepared by spiking HSV-2 virus into HSV-negative oral samples. HSV-2 virus was spiked in
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HSV-negative oral samples at concentrations 2-3X LoD, 10X LoD, 100X LoD, 1,000X LoD and 10,000X LoD. In addition. fifteen (15) HSV-1 true positive oral and fifteen (15) HSV-negative oral samples remaining from the clinical specimens used for the method comparison study were also tested. All samples were randomized and blinded to the operator prior to testing. HSV-2 was detected in all contrived samples at all concentrations tested.
Analytical Performance Characteristics
Precision/Reproducibility:
A seven-member panel was used for all studies. Panel members were formulated with a single target present (HSV-1 MacIntyre strain or HSV-2 MS strain) at three concentrations: ~2-3X LoD (Positive), IX LoD (Low Positive), and