(82 days)
Not Found
No
The description focuses on standard molecular diagnostic techniques (rRT-PCR) and does not mention any AI or ML components for data analysis or interpretation.
No
The device is an in vitro diagnostic test designed for the detection of influenza A, influenza B, and RSV RNA directly from nasopharyngeal swabs, intended as an aid in diagnosing infections, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a qualitative in vitro diagnostic test" and is "intended for use as an aid in diagnosing influenza A and/or RSV infection."
No
The device is an in vitro diagnostic test that utilizes hardware components (Abbott m2000sp and m2000rt systems) for nucleic acid extraction, purification, and real-time PCR, in addition to the software for analysis.
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 device is a "qualitative in vitro diagnostic test designed for the detection of influenza B, and RSV RNA directly from nasopharyngeal swabs...". The term "in vitro diagnostic" is clearly used.
- Device Description: The description details how the device performs nucleic acid extraction, purification, and real-time reverse transcription polymerase chain reaction (rRT-PCR) on clinical specimens (nasopharyngeal swabs) to detect viral RNA. This is a typical process for an in vitro diagnostic test.
- Performance Studies: The document describes clinical and analytical performance studies conducted to evaluate the device's accuracy and reliability in detecting the target viruses in patient samples. This is a requirement for IVD devices.
- Key Metrics: The document provides key performance metrics such as Sensitivity and Specificity, which are standard measures used to evaluate the performance of diagnostic tests.
All of these elements strongly indicate that the IMDx Flu A/B and RSV for Abbott m2000 assay is an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IMDx Flu A/B and RSV for Abbott m2000 assay performed on the Abbott m2000 System is a qualitative in vitro diagnostic test designed for the detection of influenza B, and RSV RNA directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. The assay detects RNA from influenza A. influenza B, and RSV (A and B) using real-time, reverse transcription polymerase chain reaction (rRT-PCR) and fluorogenic target specific hybridization for unique sequences in the viral target genomes. The IMDx Flu A/B and RSV for Abbott m2000 assay is intended for use as an aid in diagnosing influenza A and/or RSV infection.
Negative results for influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent(s) detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered when diagnosing respiratory viral infection.
Performance characteristics for influenza A were established during the 2011-2013 influenza seasons when Influenza A/2009 H1N1 and Influenza A/H3 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary,
If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Product codes (comma separated list FDA assigned to the subject device)
OCC, OOI
Device Description
The IMDx Flu A/B and RSV for Abbott m2000 assay uses nucleic acid extraction and purification technology, performed on the Abbott m2000sp. combined with rRT-PCR. performed with the Abbott m2000rt, to generate and detect amplified products from influenza A, influenza B, and RSV RNA that is isolated from clinical specimens.
The assay targets the influenza A matrix (M) gene, influenza B non-structural protein (NS1) gene, and RSV A and RSV B fusion (F) gene. The presence of a viral RNA target sequence 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 amplification cycle at which fluorescent signal is detected by the Abbott m2000rt is inversely proportional to the viral RNA target concentration present in the original sample.
An RNA bacteriophage species unrelated to influenza B, or RSV is introduced into each specimen during sample preparation to serve as a process control bacteriophage is lysed simultaneously with influenza A, influenza B and RSV B in the sample, and amplified in the same reaction as the viral RNA targets using rRT-PCR. The process control serves to demonstrate that the entire assay process has proceeded correctly for each sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal swabs
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
The performance of the IMDx Flu A/B and RSV for Abbott m2000 assay was assessed compared to viral culture followed by direct fluorescent antibody (DFA) detection during the course of two (2) influenza seasons (2011-2012 and 2012-2013). For the 2011-2012 season (collected February-April 2012), four (4) geographically diverse test sites within the United States prospectively collected influenza A/B and RSV samples enrolled for this study were nasopharyngeal swabs collected for routine influenza testing. A total of four hundred and ninety seven (497) specimens were included in the final data set and analyzed for product performance.
For the 2012-2013 season (collected March-April 2013), three (3) geographically diverse test sites within the United States prospectively collected influenza A/B and RSV samples enrolled for this study were nasopharyngeal swabs collected for routine influenza testing. A total of four hundred and thirty-five (435) specimens were included in the final data set and analyzed for product performance.
Between the two influenza seasons, a total of 932 NPS samples were tested and analyzed for performance.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Agreement:
Study type: Clinical Agreement compared to viral culture followed by DFA detection.
Sample size: 932 Nasopharyngeal Swab (NPS) samples (497 from 2011-2012 season; 435 from 2012-2013 season).
Key results:
Influenza A Clinical Agreement Summary (All Sites):
Sensitivity: 97.6% (94% - 99%) 95% CI
Specificity: 95.7% (94% - 97%) 95% CI
125/33 samples were confirmed as influenza A Positive using an FDA cleared molecular assay.
24/4 samples were confirmed as influenza A Negatives using an FDA cleared nucleic acid test.
Influenza B Clinical Agreement Summary (All Sites):
Sensitivity: 97.1% (90% - 99%) 95% CI
Specificity: 97.2% (96% - 98%) 95% CI
320/24 samples were confirmed as influenza B Positive using an FDA cleared molecular assay.
RSV Clinical Agreement Summary (All Sites):
Sensitivity: 97.2% (92% - 99%) 95% CI
Specificity: 93.0% (91% - 95%) 95% CI
439/58 samples were confirmed as RSV Positive using an FDA cleared molecular assay.
51/3 samples were confirmed as RSV Positive using an FDA cleared molecular assay.
Reproducibility:
Study type: Reproducibility study using a sixteen-member panel (2 influenza A strains, 1 influenza B strain, 1 RSV-A strain) at three target levels (Moderate Positive, Low Positive, High Negative) and a negative sample.
Sample size: Each panel member tested in replicates of three, twice a day, for 10 experiment runs at three sites (total of 90 samples per level per site).
Key results: Aggregate percent CV values across all sites were ≤ 3.7% for all targets, and for all concentrations tested.
Analytical Sensitivity (Limit of Detection):
Study type: LoD determination.
Key results:
Influenza A/Swine/NY/02/09 (H1N1): 3.9 x 10^0 TCID50/mL
Influenza A/Brisbane/10/07 (H3N2): 1.51 x 10^1 TCID50/mL
Influenza B/Florida/04/2006: 2.82 x 10^2 TCID50/mL
RSV A (RSVA Type A): 4.17 x 10^0 TCID50/mL
RSV B CH93-(18)-18: 1.65 x 10^0 TCID50/mL
Analytical Reactivity:
Study type: Reactivity panel testing.
Sample size: 55 strains (31 influenza A, 15 influenza B, and 9 RSV). Each strain diluted and tested in triplicate.
Key results: All strains tested were positive for their representative assay targets.
Analytical Specificity: Cross Reactivity:
Study type: Cross-reactivity testing.
Sample size: Panel of 36 organisms (respiratory pathogens or human microbiota) and purified human DNA.
Key results: No cross reactivity was observed.
Microbial Interference:
Study type: Microbial Interference study.
Sample size: 36 organisms and human DNA tested against 6 target organisms in triplicate.
Key results: No evidence of interference was observed.
Competitive Interference:
Study type: Competitive interference (co-infection) study.
Key results: No observed interference with co-infection samples; high concentration targets did not interfere with the detection of a second target that was near LoD.
Potentially Interfering Substances:
Study type: Interfering substances study.
Sample size: 6 viral strains tested in triplicate in the presence of various substances.
Key results: No interference in the performance of the IMDx Flu A/B and RSV for Abbott m2000 assay was observed. FluMist® influenza vaccine did not interfere when diluted appropriately.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Influenza A Clinical Agreement Summary (All Sites):
Sensitivity: 97.6% (94% - 99%) 95% CI
Specificity: 95.7% (94% - 97%) 95% CI
Influenza B Clinical Agreement Summary (All Sites):
Sensitivity: 97.1% (90% - 99%) 95% CI
Specificity: 97.2% (96% - 98%) 95%CI
RSV Clinical Agreement Summary (All Sites):
Sensitivity: 97.2% (92% - 99%) 95% CI
Specificity: 93.0% (91% - 95%) 95%CI
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.
(a)
Identification. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B;
(2) Influenza A subtype H1 and Influenza A subtype H3;
(3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;
(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
(5) Human Metapneumovirus;
(6) Rhinovirus; and
(7) Adenovirus.
(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.
0
510(k) SUMMARY
| Date of Summary: | August 14, 2013 |
|---|---|
| Product Name | IMDx Flu A/B and RSV for Abbott m2000 |
| 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 |
AUG 2 1 2013
| Trade or Proprietary Name: | IMDx Flu A/B and RSV for Abbott m2000 |
|---|---|
| Common or Usual Name: | Respiratory Virus Panel Nucleic Acid Assay System |
| Product Code: | OCC, OOI |
| Regulation Section: | 21CFR866.3980 |
| Device Class: | Class II |
Microbiology (83)
Intended Use
Panel:
The IMDx Flu A/B and RSV for Abbott m2000 assay performed on the Abbott m2000 System is a qualitative in vitro diagnostic test designed for the detection of influenza B, and RSV RNA directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. The assay detects RNA from influenza A. influenza B, and RSV (A and B) using real-time, reverse transcription polymerase chain reaction (rRT-PCR) and fluorogenic target specific hybridization for unique sequences in the viral target genomes. The IMDx Flu A/B and RSV for Abbott m2000 assay is intended for use as an aid in diagnosing influenza A and/or RSV infection.
Negative results for influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent(s) detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered when diagnosing respiratory viral infection.
Performance characteristics for influenza A were established during the 2011-2013 influenza seasons when Influenza A/2009 H1N1 and Influenza A/H3 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary,
If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
1
Device Description
The IMDx Flu A/B and RSV for Abbott m2000 assay uses nucleic acid extraction and purification technology, performed on the Abbott m2000sp. combined with rRT-PCR. performed with the Abbott m2000rt, to generate and detect amplified products from influenza A, influenza B, and RSV RNA that is isolated from clinical specimens.
The assay targets the influenza A matrix (M) gene, influenza B non-structural protein (NS1) gene, and RSV A and RSV B fusion (F) gene. The presence of a viral RNA target sequence 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 amplification cycle at which fluorescent signal is detected by the Abbott m2000rt is inversely proportional to the viral RNA target concentration present in the original sample.
An RNA bacteriophage species unrelated to influenza B, or RSV is introduced into each specimen during sample preparation to serve as a process control bacteriophage is lysed simultaneously with influenza A, influenza B and RSV B in the sample, and amplified in the same reaction as the viral RNA targets using rRT-PCR. The process control serves to demonstrate that the entire assay process has proceeded correctly for each sample.
Substantial Equivalency
The IMDx Flu A/B and RSV for Abbott m2000 assay is substantially equivalent to the Verigene® Respiratory Virus Plus Nucleic Acid Test on the Verigene® System (RV+) (K103209). The tables below compare the characteristics of the IMDx Flu A/B and RSV for Abbott m2000 Assay (New Device) and the Nanosphere Verigene Assay (Predicate Device).
| Similarity to Predicate Device
| Characteristic | IMDx Flu A/B and RSV for Abbott m2000 | Verigene® Respiratory Virus Plus Nucleic Acid Test on the Verigene® System (RV+) |
|---|---|---|
| 510(k) | K131584 | K103209 |
| Regulation | 866.3980 | 866.3980 |
| Product Code | OCC, OOI | OCC; NSU |
| Device Class | Class II | Class II |
| Intended use | The IMDx Flu A/B and RSV for Abbott | |
| m2000 assay performed on the Abbott m2000 | ||
| System is a qualitative in vitro diagnostic test | ||
| designed for the detection of influenza A, | ||
| influenza B, and RSV RNA directly from | ||
| nasopharyngeal swabs from patients with signs | ||
| and symptoms of respiratory infection. The | ||
| assay detects RNA from influenza A, influenza | ||
| B, and RSV (A and B) using real-time, reverse | ||
| transcription polymerase chain reaction (rRT- | ||
| PCR) and fluorogenic target specific | ||
| hybridization for unique sequences in the viral | ||
| target genomes. The IMDx Flu A/B and RSV | ||
| for Abbott m2000 assay is intended for use as | ||
| an aid in diagnosing influenza A and/or | ||
| influenza B and/or RSV infection. | The Verigene® Respiratory Virus Plus Nucleic | |
| Acid Test (RV+) on the Verigene® System is a | ||
| qualitative nucleic acid multiplex test intended to | ||
| simultaneously detect and identify multiple | ||
| respiratory virus nucleic acids in nasopharyngeal | ||
| (NP) swab specimens from individuals with | ||
| signs and symptoms of respiratory tract | ||
| infection. The following virus types and | ||
| subtypes are identified using the RV+: influenza | ||
| A, influenza A subtype H1, influenza A subtype | ||
| H3, 2009 H1N1, influenza B, Respiratory | ||
| Syncytial Virus (RSV) subtype A, and RSV | ||
| subtype B. The test is not intended to detect | ||
| influenza C virus. Detecting and identifying | ||
| specific viral nucleic acids from individuals | ||
| exhibiting signs and symptoms of respiratory | ||
| infection aids in the diagnosis of respiratory viral | ||
| Characteristic | IMDx Flu A/B and RSV for Abbott m2000 | Verigene® Respiratory Virus Plus Nucleic |
| Acid Test on the Verigene® System (RV+) | ||
| Negative results for influenza A, influenza B, | ||
| or RSV do not preclude influenza virus or | ||
| RSV infection and should not be used as the | ||
| sole basis for diagnosis, treatment, or patient | ||
| management decisions. Conversely, positive | ||
| results do not rule-out bacterial infection or co- | ||
| infection with other viruses. The agent(s) | ||
| detected may not be the definite cause of | ||
| disease. The use of additional laboratory | ||
| testing and clinical presentation must be | ||
| considered when diagnosing respiratory viral | ||
| infection. | infection, if used in conjunction with other | |
| clinical and laboratory findings. |
Negative results for influenza A, influenza B, or
RSV do not preclude influenza virus or RSV
infection and should not be used as the sole basis
for diagnosis, treatment, or patient management
decisions. Conversely, positive results do not
rule-out bacterial infection or co-infection with
other viruses. The agent detected may not be the
definite cause of disease. The use of additional
laboratory testing and clinical presentation must
be considered in order to obtain the final
diagnosis of respiratory viral infection. |
| | Performance characteristics for influenza A
were established during the 2011-2012 and
2012-2013 influenza seasons when influenza
A/2009 H1N1 and influenza A/H3 were the
predominant influenza A viruses in circulation.
When other influenza A viruses are emerging,
performance characteristics may vary. | Performance characteristics for influenza A
Virus were established when influenza A/H3,
A/H1, and 2009 H1N1 were the predominant
influenza A viruses circulating. These
characteristics may vary when other influenza A
viruses are emerging. |
| | If infection with a novel influenza A virus is
suspected based on current clinical and
epidemiological screening criteria
recommended by public health authorities,
specimens should be collected with
appropriate infection control precautions for
novel virulent influenza viruses and sent to
state or local health department for testing.
Viral culture should not be attempted in these
cases unless a BSL 3+ facility is available to
receive and culture specimens. | If infection with a novel influenza A virus is
suspected based on current clinical and
epidemiological screening criteria recommended
by public health authorities, specimens should be
collected with appropriate infection control
precautions used specifically for novel virulent
influenza viruses and sent to state or local health
department for testing. Viral culture should not
be attempted in these cases unless a BSL 3+
facility is available to receive and culture
specimens. |
| Sample type | Nasopharyngeal swabs | Nasopharyngeal swabs |
| Sample
Preparation | Automated extraction of nucleic acids | Automated extraction of nucleic acids |
| Test Principle | Real-time, reverse transcription polymerase
chain reaction (rRT-PCR) DNA amplification | Real-time, reverse transcription polymerase
chain reaction (RT-PCR) DNA amplification |
| Targets
Detected | influenza A
influenza B
RSV A/B | influenza A
influenza B
RSV A
RSV B |
| Controls | Positive Control
Negative Control
Process Control | Positive Control
Negative Control
Inhibition Control
Internal Control |
| Instrumentation | Abbott® m2000TM System (K092705) | Verigene ®System (K070804) |
Similarity to Predicate Device
2
.
3
| Differences from Predicate Device | ||||
|---|---|---|---|---|
| Characteristic | IMDx Flu A/B and RSV for Abbott m2000 | Verigene® Respiratory Virus Plus Nucleic | ||
| Acid Test on the Verigene® System (RV+) | ||||
| Throughput | Batch | Single use cassette | ||
| Viral Sub- | No | Yes | ||
| Typing |
These differences do not affect substantial equivalency of the IMDx Flu A/B and RSV for Abbott m2000 and Verigene® Respiratory Virus Plus Nucleic Acid Test. Both assays detect influenza B and RSV viral nucleic acids from nasopharyngeal swabs and the assays have comparable intended uses. The differences noted above do not change the intended use and do not raise different questions of safety and effectiveness.
Performance Characteristics
Clinical Agreement
The performance of the IMDx Flu A/B and RSV for Abbott m2000 assay was assessed compared to viral culture followed by direct fluorescent antibody (DFA) detection during the course of two (2) influenza seasons (2011-2012 and 2012-2013). For the 2011-2012 season (collected February-April 2012), four (4) geographically diverse test sites within the United States prospectively collected influenza A/B and RSV samples enrolled for this study were nasopharyngeal swabs collected for routine influenza testing. A total of four hundred and ninety seven (497) specimens were included in the final data set and analyzed for product performance.
For the 2012-2013 season (collected March-April 2013), three (3) geographically diverse test sites within the United States prospectively collected influenza A/B and RSV samples enrolled for this study were nasopharyngeal swabs collected for routine influenza testing. A total of four hundred and thirty-five (435) specimens were included in the final data set and analyzed for product performance.
| Patient Population | ||||
|---|---|---|---|---|
| Age and Gender Distribution | ||||
| Age | Female | Male | ||
| 2011-2012 | 2012-2013 | 2011-2012 | 2012-2013 | |
| ≤5 years | 84 (30.1%) | 71 (31.8%) | 76 (34.7%) | 101 (47.6%) |
| 6 - 21 years | 38 (13.6%) | 29 (13.0%) | 45 (20.5%) | 28 (13.2%) |
| 22 - 59 years | 96 (34.4%) | 76 (34.1%) | 63 (28.9%) | 44 (20.7%) |
| ≥ 60 years | 61 (21.9%) | 47 (21.1%) | 34 (15.5%) | 39 (18.4%) |
| Season Totals | 279 | 223 | 218 | 212 |
| Overall Totals | 502 | 430 |
Between the two influenza seasons, a total of 932 NPS samples were tested and analyzed for performance. Results are shown below. Discordant samples were tested using the Nanosphere Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System and subsequent results are documented in the footnote.
4
Influenza A Clinical Agreement Summary
| All Sites
| Influenza A | Viral Culture | |||||
|---|---|---|---|---|---|---|
| Positive | Negative | Total | ||||
| IMDx Flu A/B | ||||||
| and RSV for | ||||||
| Abbott m 2000 | ||||||
| Assay | Positive | 164 | 331 | 197 | Sensitivity | 97.6% (94% - 99%) 95% CI |
| Negative | 42 | 731 | 735 | Specificity | 95.7% (94% - 97%) 95% CI | |
| Total | 168 | 764 | 932 |
125/33 samples were confirmed as influenza A Positive using an FDA cleared molecular assay.
24/4samples were confirmed as influenza A Negatives using an FDA cleared nucleic acid test.
Influenza B Clinical Agreement Summary
| All Sites | Viral Culture | |||||
|---|---|---|---|---|---|---|
| Influenza B | Positive | Negative | Total | |||
| IMDx Flu A/B | Positive | 67 | 243 | 91 | Sensitivity | 97.1% (90% - 99%) 95% CI |
| and RSV for | ||||||
| Abbott m2000 | ||||||
| Assay | Negative | 2 | 839 | 841 | Specificity | 97.2% (96% - 98%) 95%CI |
| Total | 69 | 863 | 932 |
320/24 samples were confirmed as influenza B Positive using an FDA cleared molecular assay.
RSV Clinical Agreement Summary
| All Sites
| RSV | Viral Culture | |||||
|---|---|---|---|---|---|---|
| Positive | Negative | Total | ||||
| IMDx Flu A/B | ||||||
| and RSV for | ||||||
| Abbott m2000 | ||||||
| Assay | Positive | 104 | 584 | 162 | Sensitivity | 97.2% (92% - 99%) 95% CI |
| Negative | 35 | 767 | 770 | Specificity | 93.0% (91% - 95%) 95%CI | |
| Total | 69 | 825 | 932 |
439/58 samples were confirmed as RSV Positive using an FDA cleared molecular assay.
51/3 samples were confirmed as RSV Positive using an FDA cleared molecular assay.
Analytical Performance
Reproducibility
A sixteen-member panel was used for the reproducibility study. The panel was made with 2 influenza A strains (one HINI and one H3N2), one influenza B strain, one RSV-A strain. Each strain. Each strain was spiked in M4RT viral transport medium at three different approximate target levels: Moderate Positive (~2-3X LoD), Low Positive (1X LoD) and High Negative (0.2 - 0.8X LoD). Panel members were formulated with only one target present (influenza A, influenza B, RSV-A, RSV-B). A negative sample (transport medium only) was also included.
Each panel member was tested in replicates of three, twice a days, for a total of 10 experiment runs. Testing was conducted at three site, the runs were performed by two operators, with each operator performing one run each day.
To conduct the site-to-site reproducibility study, panel members (moderate positive, high negative, and negative) for each virus were randomized and sample identities were blinded to the user. Each panel member was tested in replicates of three, twice a day for five days, for a total of 10 runs. Testing was conducted at three sites. At cach site, the runs were performed by two operator performing one run each day. The entire study was conducted using the same instrument system (Abbott m2000rt) at each site, and one reagent lot of
5
the IMDx Flu A/B and RSV for Abbott m2000 kits. The aggregate percent CV values across all sites were ≤ 3.7% for all targets, and for all concentrations tested.
| Site 1 | Site 2 | Site 3 | All 3 Sites | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Specific Panel | |||||||||
| Member | Level | % Agreement | |||||||
| (Agreement | |||||||||
| with expected | |||||||||
| result) | Avg. CN | ||||||||
| (%CV) | % Agreement | ||||||||
| (Agreement | |||||||||
| with expected | |||||||||
| result) | Avg. CN | ||||||||
| (%CV) | % Agreement | ||||||||
| (Agreement | |||||||||
| with expected | |||||||||
| result) | Avg. CN | ||||||||
| (%CV) | % Agreement | ||||||||
| (95% CI) | Avg. CN | ||||||||
| (%CV) | |||||||||
| Moderate | |||||||||
| Positive | 100.00 | ||||||||
| (30/30) | 33.52 | ||||||||
| (2.46) | 100.00 | ||||||||
| (30/30) | 34.28 | ||||||||
| (2.17) | 93.33 | ||||||||
| (28/30) | 33.76 | ||||||||
| (2.58) | 97.78 | ||||||||
| (94.73 - 100.00) | 33.85 | ||||||||
| (2.28) | |||||||||
| influenza A | |||||||||
| (H1N1) | Low Positive | 100.00 | |||||||
| (30/30) | 34.95 | ||||||||
| (1.67) | 100.00 | ||||||||
| (30/30) | 35.83 | ||||||||
| (2.41) | 96.67 | ||||||||
| (29/30) | 35.16 | ||||||||
| (3.21) | 97.78 | ||||||||
| (94.73 - 100.00) | 35.31 | ||||||||
| (2.35) | |||||||||
| High | |||||||||
| Negative | 36.67 | ||||||||
| (11/30) | 36.92 | ||||||||
| (4.67) | 33.33 | ||||||||
| (10/30) | 37.88 | ||||||||
| (1.99) | 33.33 | ||||||||
| (10/30) | 37.43 | ||||||||
| (3.31) | 34.44 | ||||||||
| (24.63 - 44.26) | 37.38 | ||||||||
| (3.04) | |||||||||
| Moderate | |||||||||
| Positive | 100.00 | ||||||||
| (30/30) | 33.26 | ||||||||
| (1.77) | 100.00 | ||||||||
| (30/30) | 33.65 | ||||||||
| (1.37) | 100.00 | ||||||||
| (30/30) | 33.31 | ||||||||
| (1.59) | 100.00 | ||||||||
| (100.00 - 100.00) | 33.41 | ||||||||
| (1.53) | |||||||||
| Influenza A | |||||||||
| (H3N2) | Low Positive | 100.00 | |||||||
| (30/30) | 34.61 | ||||||||
| (1.29) | 100.00 | ||||||||
| (30/30) | 34.85 | ||||||||
| (1.22) | 100.00 | ||||||||
| (30/30) | 35.04 | ||||||||
| (1.96) | 100.00 | ||||||||
| (100.00 - 100.00) | 34.83 | ||||||||
| (1.50) | |||||||||
| High | |||||||||
| Negative | 6.67 | ||||||||
| (2/30) | 36.53 | ||||||||
| (1.41) | 16.67 | ||||||||
| (5/30) | 37.31 | ||||||||
| (1.81) | 20.00 | ||||||||
| (6/30) | 37.28 | ||||||||
| (1.88) | 14.44 | ||||||||
| (7.18-21.71) | 37.04 | ||||||||
| (1.72) | |||||||||
| Moderate | |||||||||
| Positive | 100.00 | ||||||||
| (30/30) | 32.25 | ||||||||
| (1.37) | 96.67 | ||||||||
| (29/30) | 32.18 | ||||||||
| (1.33) | 100.00 | ||||||||
| (30/30) | 32.22 | ||||||||
| (0.79) | 98.89 | ||||||||
| (96.72 - 100.00) | 32.22 | ||||||||
| (1.13) | |||||||||
| Influenza B | Low Positive | 96.67 | |||||||
| (29/30) | 33.91 | ||||||||
| (0.81) | 96.67 | ||||||||
| (29/30) | 33.89 | ||||||||
| (1.21) | 73.33 | ||||||||
| (22/30) | 33.89 | ||||||||
| (1.00) | 88.89 | ||||||||
| (82.40 - 95.38) | 33.90 | ||||||||
| (1.01) | |||||||||
| High | |||||||||
| Negative | 30.00 | ||||||||
| (9/30) | 34.53 | ||||||||
| (1.07) | 36.67 | ||||||||
| (11/30) | 34.74 | ||||||||
| (0.90) | 53.33 | ||||||||
| (16/30) | 34.50 | ||||||||
| (1.07) | 40.00 | ||||||||
| (29.88 - 50.12) | 34.53 | ||||||||
| (0.93) | |||||||||
| Moderate | |||||||||
| Positive | 100.00 | ||||||||
| (30/30) | 32.62 | ||||||||
| (3.52) | 100.00 | ||||||||
| (30/30) | 32.10 | ||||||||
| (4.82) | 93.33 | ||||||||
| (28/30) | 32.47 | ||||||||
| (2.60) | 97.78 | ||||||||
| (94.73 - 100.00) | 32.39 | ||||||||
| (3.64) | |||||||||
| RSV-A | Low Positive | 96.67 | |||||||
| (29/30) | 33.63 | ||||||||
| (2.15) | 96.67 | ||||||||
| (29/30) | 33.57 | ||||||||
| (2.47) | 100.00 | ||||||||
| (30/30) | 33.15 | ||||||||
| (3.21) | 97.78 | ||||||||
| (94.73 - 100.00) | 33.45 | ||||||||
| (2.52) | |||||||||
| High | |||||||||
| Negative | 6.67 | ||||||||
| (2/30) | 34.93 | ||||||||
| (2.80) | 6.67 | ||||||||
| (2/30) | 35.03 | ||||||||
| (1.90) | 23.33 | ||||||||
| (7/30) | 34.50 | ||||||||
| (3.07) | 12.22 | ||||||||
| (5.46 - 18.99) | 34.82 | ||||||||
| (2.48) | |||||||||
| Moderate | |||||||||
| Positive | 96.67 | ||||||||
| (29/30) | 32.68 | ||||||||
| (1.90) | 100.00 | ||||||||
| (30/30) | 32.39 | ||||||||
| (2.14) | 90.00 | ||||||||
| (27/30) | 31.78 | ||||||||
| (2.54) | 95.56 | ||||||||
| (91.30 - 99.81) | 32.29 | ||||||||
| (2.18) | |||||||||
| RSV-B | Low Positive | 86.67 | |||||||
| (26/30) | 35.20 | ||||||||
| (1.91) | 86.67 | ||||||||
| (26/30) | 35.21 | ||||||||
| (1.50) | 70.00 | ||||||||
| (21/30) | 34.63 | ||||||||
| (2.14) | 81.11 | ||||||||
| (73.02 - 89.20) | 35.02 | ||||||||
| (1.83) | |||||||||
| High | |||||||||
| Negative | 70.00 | ||||||||
| (21/30) | 36.78 | ||||||||
| (0.95) | 86.67 | ||||||||
| (26/30) | 36.55 | ||||||||
| (1.20) | 80.00 | ||||||||
| (24/30) | 36.06 | ||||||||
| (1.76) | 78.89 | ||||||||
| (70.46 - 87.32) | 36.23 | ||||||||
| (0.83) | |||||||||
| Negative | Negative | 100.00 | |||||||
| (30/30) | -1.00 | ||||||||
| (0.00) | 100.00 | ||||||||
| (30/30) | -1.00 | ||||||||
| (0.00) | 100.00 | ||||||||
| (30/30) | -1.00 | ||||||||
| (0.00) | 100.00 | ||||||||
| (100.00 - 100.00) | -1.00 | ||||||||
| (0.00) |
Analytical Sensitivity (Limit of Detection)
The Analytical Sensitivity, or Limit of Detection (LoD), is defined as the concentration at which ≥ 95% of all replicates tested positive. The LoD for the IMDx Flu A/B and RSV for Abbott m2000 assay was determined using two strains of influenza A, two strains of influenza B, one strain of RSV-A, and one strain of RSV-B. Volumes of each dilution tested were in accordance with sample processing instructions provided in this package insert, and are representative of the amount of material collected by swab sampling methods. The results are summarized in the table below.
| Strain | LoD |
|---|---|
| Influenza A/Swine/NY/02/09 (H1N1) | $3.9 x 10^0$ TCID50/mL |
| Influenza A/Brisbane/10/07 (H3N2) | $1.51 x 10^1$ TCID50/mL |
| Influenza B/Florida/04/2006 | $2.82 x 10^2$ TCID50/mL |
| RSV A (RSVA Type A) | $4.17 x 10^0$ TCID50/mL |
| RSV B CH93-(18)-18 | $1.65 x 10^0$ TCID50/mL |
| Strain | Concentration Tested |
| A/California/7/2009 (H1N1) | 1.07 x 102 CEID50/mL |
| A/New Caledonia/20/99 (H1N1) | 2.62 x 101 TCID50/mL |
| A/Solomon Islands/3/2006 (H1N1) | 6.19 x 100 TCID50/mL |
| A/PR/8/34 (H1N1) | 1.56 x 100 TCID50/mL |
| A/WS/33 (H1N1) | 4.88x 10-1 CEID50/mL |
| A/Brisbane/59/07 (H1N1) | 2.49 x 101 TCID50/mL |
| A/Swine/Canada/6294/09 (H1N1) | 6.57 x 100 TCID50/mL |
| A/NJ/8/76 (H1N1) | 5.91 x 100 TCID50/mL |
| A/NWS/33 (H1N1) | 4.05 x 100 CEID50/mL |
| A/FM/1/47 (H1N1) | 1.20 x 101 CEID50/mL |
| A/Mal/302/54 (H1N1) | 1.86 x 100 CEID50/mL |
| A/Denver/1/57 (H1N1) | 7.48 x 101 CEID50/mL |
| A/Virginia/ATCC2/2009 (H1N1) | 5.91 x 100 CEID50/mL |
| A/Wisconsin/67/05 (H3N2) | 4.85 x 101 TCID50/mL |
| A/MRC2 (H3N2) | 1.56 x 102 CEID50/mL |
| A/Aichi/2/26 (H3N2) | 2.85 x 102 CEID50/mL |
| A/Victoria/3/75 (H3N2) | 8.87 x 100 CEID50/mL |
| A/Port Chalmers/1/73 (H3N2) | 3.64 x 102 TCID50/mL |
| A/Perth/16/09 (H3N2) | 3.79 x 100 TCID50/mL |
| A/Hong Kong/8/68 (H3N2) | 5.10 x 100 TCID50/mL |
| A/Rhode Island/01/2010 (H3N2) | 1.50 x 103 TCID50/mL |
| A/New York/55/2004 (H3N2) | 2.58 x 102 TCID50/mL |
| A/Uruguay/716/2007 (H3N2) | 9.79 x 102 TCID50/mL |
| A/Florida/2/2006 (H3N2) | 2.28 x 102 TCID50/mL |
| A/Victoria/361/2011 (H3N2) | 3.84 x 102 CEID50/mL |
| A/Indiana/10/2011 (H3N2v) | 4.61 x 102 TCID50/mL |
| A/Texas/71/2007 (H3N2v) | 1.56 x 100 TCID50/mL |
| A/Indiana/08/2011 (H3N2v) | 2.60 x 100 TCID50/mL |
| B/Mass/3/66 | 1.78 x 101 CEID50/mL |
| B/Allen/45 | 1.00 x 104 CEID50/mL |
| B/Lee/40 | 1.00 x 104 CEID50/mL |
| B/Maryland/1/59 | 1.00 x 103 CEID50/mL |
| B/Florida/07/04 | 1.82 x 101 TCID50/mL |
| B/Florida/02/2006 | 3.43 x 100 TCID50/mL |
| B/Hong Kong/5/72 | 1.19 x 101 CEID50/mL |
| B/RUSSIA/69 | 9.99 x 100 CEID50/mL |
| B/TAIWAN/2/62 (93-02) | 1.00 x 103 CEID50/mL |
| B/GL/1739/54 | 1.00 x 106 CEID50/mL |
| B/Brisbane/60/08 | 2.01 x 10-1 TCID50/mL |
| B/Wisconsin/01/2010 | 3.20 x 100 CEID50/mL |
| B/Santiago/4360/2007 | 1.61 x 100 CEID50/mL |
| B/Texas/39/2006 | 5.91 x 101 CEID50/mL |
| B/Ohio/01/2005 | 1.19 x 102 CEID50/mL |
| RSV/A2 | 7.42 x 100 TCID50/mL |
| RSVA/Long | 7.08 x 103 TCID50/mL |
| RSVA 1998/12-21 | 2.10 x 101 TCID50/mL |
| RSVA 1998/3-2 | 6.97 x 100 TCID50/mL |
| RSVA 2001/2-20 | 4.09 x 100 TCID50/mL |
| RSVA 2001/3-12 | 9.97 x 100 TCID50/mL |
| RSVB/9320 | 8.39 x 100 TCID50/mL |
| RSVB/WV/14617/85 | 1.79 x 100 TCID50/mL |
Analytical Reactivity
A panel of 55 strains (31 influenza A, 15 influenza B, and 9 RSV) was tested for their ability to be detected by the IMDx Flu A/B and RSV for Abbott m2000 assay. Each strain was diluted in viral transport media and tested in triplicate. All strains tested were positive for their representative assay targets.
6
.
:
7
| Strain | Concentration Tested |
|---|---|
| A/duck/Pennsylvania/10218/84 | |
| (H5N2)* | 23 pg/μL |
| A/HongKong/33982/2009 (H9N2)* | 57 pg/μL |
Denotes testing on purified genomic RNA
Analytical Specificity: Cross Reactivity
A panel of 36 organisms from respiratory pathogens or human microbiota, and purified human DNA were tested at approximately 1x106 CFU/mL for bacteria, 1x105 TCIDs/mL for viruses, and 1.0x104 copies/mL for human DNA using the IMDx Flu A/B and RSV for Abbott m2000 assay. No cross reactivity was observed for the IMDx Flu A/B and RSV for Abbott m2000 assay.
Microbial Interference
The same panel of 36 organisms from respiratory pathogens or human microbiota, and purified human DNA at concentrations of approximately 1x10 CFU/mL for bacteria, 1x10 TCID-30/mL for viruses, and 1.0x10 copies/mL for human DNA were added to sample tubes containing one of six target organisms; two influenza B and two RSV strains in viral transport medium. The two influenza A strains used for this study were influenza A/Swine/NY/02/2009 (H1N1) and influenza A/Brisbane/10/2007 (H3N2). The two influenza B strains used for this study were influenza B/Florida/04/2006 (V/87) and influenza B/Malaysia/2506/2004 (YA/88). The two RSV strains used for this study were RSV A Type A and RSV B CH93-18(18). Assay analytes were present in the samples at concentrations corresponding to 2-3X LoD. Each of the six strains was tested against the 36 member panel in triplicate using the IMDx Flu A/B and RSV for Abbott m2000 assay. No evidence of interference was observed.
| Organism |
|---|
| Adenovirus type I |
| Adenovirus type 7A |
| Bordetella pertussis |
| Candida albicans |
| Coronavirus |
| Corynebacterium ulcerans |
| Coxsackievirus |
| Cytomegalovirus (CMV) |
| Epstein-Barr Virus (EBV) |
| Escherichia coli |
| Haemophilus influenza |
| Human Herpes Virus 6 (HHV6), Z29 strain |
| Human Herpes Virus 7 (HHV7), SB Strain |
| Human genomic DNA* |
| Klebsiella pneumoniae |
| Lactobacillus acidophilus Z048 |
| Legionella pneumoniae |
| Moraxella catarrhalis |
| Mycoplasma hominis |
| Mycoplasma pneumoniae |
| Neisseria meningitidis |
| Neisseria gonorrhoeae |
| Parainfluenza virus 1 |
| Parainfluenza virus 2 |
| Parainfluenza virus 3 |
8
| Organism |
|---|
| Pseudomonas aeruginosa |
| Staphylococcus aureus MRSA |
| Staphylococcus aureus MSSA |
| Staphylococcus epidermidis MRSE |
| Streptococcus pneumoniae |
| Streptococcus salivarius |
| Measles Virus |
| Mumps |
| Metapneumovirus 3 type B1 |
| Metapneumovirus 9 type A1 |
| Rhinovirus |
| Influenza A/Swine/NY/02/09** |
| Influenza A/Brisbane/10/07** |
| Influenza B/Florida/04/06** |
| Influenza B/Malaysia/2506/04** |
| RSVA Type A strain** |
| RSVB CH93-18(18)** |
Human Genomic DNA ≥ 1.0 X10
** * Tested in competitive interference study
** Tested in competitive interference study.
Competitive Interference
A competitive interference, or co-infection, study was performed to test whether a high titer of one virus would interfere with the detection of a second target virus that was present at low titer. High titered samples were formulated at concentrations of 2 x 10 TCID30mL, and low titered targets were formulated at a concentration of approximately 2-3X LoD for that strain. One strain each of influenza B, and RSV was used in this study. Each virus type was tested at low titers in conjunction with a high titer of each of the other two virus types, and samples were tested in triplicate. There was no observed interference with co-infection samples from the competitive interference study; high concentration targets did not interfere with the detection of a second target that was near LoD.
Potentially Interfering Substances
The susceptibility of the IMDx Flu A/B and RSV for Abbott m2000 assay to interference by elevated levels of cndogenous substances or exogenous was evaluated. Six viral strains were evaluated: two influenza A strains: A/Swine NY/02/09 (H/N) and A/Brisbane/10/07 (H3N2); two influenza B strains: B/Florida/07 and B/Malaysia/2506/04; two RSV strains: RSV-A and RSV-B CH93-(18)-18. These test organisms were diluted to a concentration of 2-3X LoD using M4RT viral transport medium. The test panel consisted of substances that may be found in nasopharyngeal swab specimens (listed in the Table below). Testing was conducted using one lot of IMDx Flu A/B and RSV for Abbott m2000 amplification reagents. Substances were diluted in viral transport media to concentrations that would either replicate or exceed the highest concentration expected to be found in a clinical sample. Each of the 6 viral strains was tested in triplicate in the presence of each substance. No interference in the performance of the IMDx Flu A/B and RSV for Abbott m2000 assay was observed.
| Substance | Active Ingredients and Potential Interferents in
Substance |
|--------------|---------------------------------------------------------------|
| Nasal Sprays | Oxymetazoline |
| | Phenylephrine |
| | Sodium chloride (with preservatives) |
| Nasal Gel | Galphimia glauca |
| | Luffa operculata |
| | Sulfur |
9
| Substance | Active Ingredients and Potential Interferents in
Substance |
|---------------------------|---------------------------------------------------------------|
| | Fluticasone |
| | Mometasone furoate |
| | Budesonide |
| | Flunisolide |
| | Triamcinolone acetonide |
| | Beclomethasone |
| NSAIDs | Aspirin |
| | Ibuprofen |
| | Naproxen |
| Acetaminophen | Acetaminophen |
| Relenza® | Zanamivir |
| Antibacterial, systemic | Tobramycin |
| Benzocaine | Benzocaine |
| Antibiotic nasal ointment | Mupirocin |
| Allergy medicine | Histamine hydrochloricum |
| Mucus (bovine) | Mucin protein, type 1-S |
| Blood (Human) | Whole Blood with EDTA |
In addition to the substances listed above, the FluMist® influenza vaccine was tested for its ability to interfere with the IMDx Flu A/B and RSV for Abbott m2000 assay. FluMist contains live attenuated reassortants of each of the three A/California/07/2009 (H1N1), Influenza A/Perth/16/2009 strains: Influenza (H3N2), and Influenza B/Brisbane/60/2008 and is administered intranasally. Initial testing of FluMist® influenza vaccine at a concentration of 10%5 to 1015 units gave detected signals for influenza B, but the influenza A and B CN values were higher than expected, indicating that the assay detected the viruses present in the vaccine. When the vaccine was diluted to 1 x 10 ° and then tested using the IMDx Flu A/B and RSV for Abbott m2000 assay, influenza A and B were not detected. When the diluted vaccine was used for interference was observed; all test strains of influenza A, influenza B, and RSV were detected as expected.
Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
10
Image /page/10/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized caduceus, a symbol often associated with healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.
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, MDC Associates, LLC. 180 CABOT STREET BEVERLY MA 01915
August 21, 2013
Re: K131584
Trade/Device Name: IMDx Flu A/B and RSV for Abbott m2000 Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: II Product Code: OCC, OOI Dated: May 29, 2013 Received: May 31, 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 moset 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.
11
Page 2-Ms. White
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 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/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sally A Hojvat -S
Sally 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
12
Indications for Use
510(k) Number (if known): K131584
Device Name: IMDx Flu A/B and RSV for Abbott m2000
Indications for Use:
The IMDx Flu A/B and RSV for Abbott m2000 assay performed on the Abbott m2000 System is a qualitative in vitro diagnostic test designed for the detection of influenza B, and RSV RNA directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. The assay detects RNA from influenza A. influenza B, and RSV (A and B) using real-time, reverse transcription polymerase chain reaction (rRT-PCR) and fluorogenic target specific hybridization for unique sequences in the viral target genomes. The IMDx Flu A/B and RSV for Abbott m2000 assay is intended for use as an aid in diagnosing influenza A and/or RSV infection.
Negative results for influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent(s) detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered when diagnosing respiratory viral infection.
Performance characteristics for influenza A were established during the 2011-2013 influenza seasons when Influenza A/2009 H1N1 and Influenza A/H3 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices and Radiological Health (OIR)
Tamara V. Feldblyum -S 2013.08.15 15:53:36 -04'00'
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