K242465 · Hologic, Inc. · QOF · Nov 15, 2024 · Microbiology
Device Facts
Record ID
K242465
Device Name
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
Applicant
Hologic, Inc.
Product Code
QOF · Microbiology
Decision Date
Nov 15, 2024
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 866.3981
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay is a fully automated multiplexed real-time polymerase chain reaction (RT-PCR) in vitro diagnostic test intended for the qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus (Flu A), influenza B virus (Flu B), and respiratory syncytial virus (RSV). Nucleic acids are isolated and purified from nasopharyngeal (NP) swab specimens and anterior nasal (AN) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza, and RSV can be similar. This assay is intended to aid in the differential diagnosis of SARS-CoV-2, Flu A, Flu B, and RSV infections in humans and is not intended to detect influenza C virus infections. Nucleic acids from the viral organisms identified by this test are generally detectable in NP and AN swab specimens during the acute phase of infection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infective of the presence of the identified virus and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out coinfection with other organism(s) detected by the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus, or RSV infections. This assay is designed for use on the Panther Fusion system.
Device Story
Fully automated multiplexed real-time RT-PCR assay for Panther Fusion system; detects SARS-CoV-2, Flu A, Flu B, and RSV RNA. Input: NP or AN swab specimens in eSTM (RespDirect) or VTM/UTM. Process: automated sample lysis, magnetic particle-based nucleic acid capture/elution, and multiplex RT-PCR amplification. Output: qualitative results for each analyte plus cycle threshold (Ct) values. Used in clinical laboratories by professional users. Provides differential diagnosis for symptomatic patients; aids clinical decision-making when combined with other findings. Benefits include rapid, automated, high-throughput testing for common respiratory pathogens.
Clinical Evidence
Prospective multicenter study (n=1033) and enrichment study (n=210) evaluated performance of AN swabs in eSTM. Prospective study: SARS-CoV-2 PPA 99.1%, NPA 99.0%; Flu A PPA 100%, NPA 99.9%; Flu B PPA 83.3%, NPA 99.8%; RSV PPA 100%, NPA 99.9%. Enrichment study (supplemental for low prevalence): Flu A PPA 97.2%, NPA 93.2%; Flu B PPA 97.8%, NPA 99.4%; RSV PPA 98.4%, NPA 95.8%.
Technological Characteristics
Multiplex real-time RT-PCR; automated nucleic acid extraction/amplification on Panther Fusion system. Targets: ORF1ab (SARS-CoV-2), Matrix (Flu A, Flu B, RSV). Fluorophores: ROX (SARS-CoV-2), FAM (Flu A), HEX (RSV), RED647 (Flu B). Internal Control-S (RED677). Uses magnetic particles for capture. Software version 7.2.7 or 7.2.9.
Indications for Use
Indicated for qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and RSV in nasopharyngeal (NP) and anterior nasal (AN) swab specimens from symptomatic individuals. Not for influenza C detection. Results aid diagnosis alongside clinical/epidemiological data; not sole basis for patient management.
Regulatory Classification
Identification
A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) The intended use in the labeling required under § 809.10 of this chapter must include a description of the following: Analytes and targets the device detects and identifies, the specimen types tested, the results provided to the user, the clinical indications for which the test is to be used, the specific intended population(s), the intended use locations including testing location(s) where the device is to be used (if applicable), and other conditions of use as appropriate.
(2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device.
(3) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens;
(ii) Detailed descriptions of the performance characteristics of the device for each specimen type claimed in the intended use based on analytical studies including the following, as applicable: Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, precision, reproducibility, and clinical studies;
(iii) Detailed descriptions of the test procedure(s), the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing;
(iv) A warning statement that viral culture should not be attempted in cases of positive results for SARS-CoV-2 and/or any similar microbial agents unless a facility with an appropriate level of laboratory biosafety (
*e.g.,* BSL 3 and BSL 3+, etc.) is available to receive and culture specimens; and(v) A prominent statement that device performance has not been established for specimens collected from individuals not identified in the intended use population (
*e.g.,* when applicable, that device performance has not been established in individuals without signs or symptoms of respiratory infection).(vi) Limiting statements that indicate that:
(A) A negative test result does not preclude the possibility of infection;
(B) The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician;
(C) There is a risk of incorrect results due to the presence of nucleic acid sequence variants in the targeted pathogens;
(D) That positive and negative predictive values are highly dependent on prevalence;
(E) Accurate results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results; and
(F) When applicable (
*e.g.,* recommended by the Centers for Disease Control and Prevention, by current well-accepted clinical guidelines, or by published peer-reviewed literature), that the clinical performance may be affected by testing a specific clinical subpopulation or for a specific claimed specimen type.(4) Design verification and validation must include:
(i) Detailed documentation, including performance results, from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, as appropriate, additional characterized clinical samples. The clinical study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained using a comparator that FDA has determined is appropriate. Detailed documentation must include the clinical study protocol (including a predefined statistical analysis plan), study report, testing results, and results of all statistical analyses.
(ii) Risk analysis and documentation demonstrating how risk control measures are implemented to address device system hazards, such as Failure Modes Effects Analysis and/or Hazard Analysis. This documentation must include a detailed description of a protocol (including all procedures and methods) for the continuous monitoring, identification, and handling of genetic mutations and/or novel respiratory pathogen isolates or strains (
*e.g.,* regular review of published literature and periodic in silico analysis of target sequences to detect possible mismatches). All results of this protocol, including any findings, must be documented and must include any additional data analysis that is requested by FDA in response to any performance concerns identified under this section or identified by FDA during routine evaluation. Additionally, if requested by FDA, these evaluations must be submitted to FDA for FDA review within 48 hours of the request. Results that are reasonably interpreted to support the conclusion that novel respiratory pathogen strains or isolates impact the stated expected performance of the device must be sent to FDA immediately.(iii) A detailed description of the identity, phylogenetic relationship, and other recognized characterization of the respiratory pathogen(s) that the device is designed to detect. In addition, detailed documentation describing how to interpret the device results and other measures that might be needed for a laboratory diagnosis of respiratory infection.
(iv) A detailed device description, including device components, ancillary reagents required but not provided, and a detailed explanation of the methodology, including molecular target(s) for each analyte, design of target detection reagents, rationale for target selection, limiting factors of the device (
*e.g.,* saturation level of hybridization and maximum amplification and detection cycle number, etc.), internal and external controls, and computational path from collected raw data to reported result (*e.g.,* how collected raw signals are converted into a reported signal and result), as applicable.(v) A detailed description of device software, including software applications and hardware-based devices that incorporate software. The detailed description must include documentation of verification, validation, and hazard analysis and risk assessment activities, including an assessment of the impact of threats and vulnerabilities on device functionality and end users/patients as part of cybersecurity review.
(vi) For devices intended for the detection and identification of microbial agents for which an FDA recommended reference panel is available, design verification and validation must include the performance results of an analytical study testing the FDA recommended reference panel of characterized samples. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(vii) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiation between the Influenza A virus subtypes in human clinical specimens, the design verification and validation must include a detailed description of the identity, phylogenetic relationship, or other recognized characterization of the Influenza A and B viruses that the device is designed to detect, a description of how the device results might be used in a diagnostic algorithm and other measures that might be needed for a laboratory identification of Influenza A or B virus and of specific Influenza A virus subtypes, and a description of the clinical and epidemiological parameters that are relevant to a patient case diagnosis of Influenza A or B and of specific Influenza A virus subtypes. An evaluation of the device compared to a currently appropriate and FDA accepted comparator method. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(5) When applicable, performance results of the analytical study testing the FDA recommended reference panel described in paragraph (b)(4)(vi) of this section must be included in the device's labeling under § 809.10(b) of this chapter.
(6) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiation between the Influenza A virus subtypes in human clinical specimens in addition to detection of SARS-CoV-2 and similar microbial agents, the required labeling under § 809.10(b) of this chapter must include the following:
(i) Where applicable, a limiting statement that performance characteristics for Influenza A were established when Influenza A/H3 and A/H1-2009 (or other pertinent Influenza A subtypes) were the predominant Influenza A viruses in circulation.
(ii) Where applicable, a warning statement that reads 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 departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
(iii) Where the device results interpretation involves combining the outputs of several targets to get the final results, such as a device that both detects Influenza A and differentiates all known Influenza A subtypes that are currently circulating, the device's labeling must include a clear interpretation instruction for all valid and invalid output combinations, and recommendations for any required followup actions or retesting in the case of an unusual or unexpected device result.
(iv) A limiting statement that if a specimen yields a positive result for Influenza A, but produces negative test results for all specific influenza A subtypes intended to be differentiated (
*i.e.,* H1-2009 and H3), this result requires notification of appropriate local, State, or Federal public health authorities to determine necessary measures for verification and to further determine whether the specimen represents a novel strain of Influenza A.(7) If one of the actions listed at section 564(b)(1)(A) through (D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those influenza viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized influenza viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's labeling required under § 809.10(b) of this chapter that accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that accompanies the device, prominently providing a hyperlink to the manufacturer's public website where the analytical reactivity testing data can be found. The manufacturer's website, as well as the primary part of the manufacturer's website that discusses the device, must provide a prominently placed hyperlink to the website containing this information and must allow unrestricted viewing access.
K222736 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay · Hologic, Inc. · May 16, 2023
Submission Summary (Full Text)
{0}
FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY AND INSTRUMENT
## I Background Information:
A 510(k) Number
K242465
B Applicant
Hologic, Inc.
C Proprietary and Established Names
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QOF | Class II | 21 CFR 866.3981 - Device To Detect And Identify Nucleic Acid Targets In Respiratory Specimens From Microbial Agents That Cause The SARS-Cov-2 Respiratory Infection And Other Microbial Agents When In A Multi-Target Test | MI - Microbiology |
| OOI | Class II | 21 CFR 862.2570 - Instrumentation for clinical multiplex test systems | CH - Clinical Chemistry |
## II Submission/Device Overview:
### A Purpose for Submission:
To expand the Intended Use of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay, which was originally FDA-cleared under K222736 for use with nasopharyngeal swab (NPS) specimens in UTM/VTM or eSTM (RespDirect). In K241240, the intended use was expanded to include testing of anterior nasal (AN) swab specimens in UTM/VTM. This current submission includes
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
{1}
testing of AN swab specimens that are collected with the Hologic RespDirect Collection Kit and eluted in eSTM media.
## B Measurand:
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay detects SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus RNA isolated from NPS specimens and AN swab specimens from individuals with signs and symptoms of a respiratory tract infection.
## C Type of Test:
This assay is a multiplexed nucleic acid test that detects and differentiates SARS-CoV-2, influenza A, influenza B, and RSV through nucleic acid extraction, amplification, and detection using real-time RT-PCR. All steps of the assay are automated, after the manual addition of sample into the sample lysis tube (SLT) and performed within the Panther and Panther Fusion system.
## III Intended Use/Indications for Use:
### A Intended Use(s):
See Indications for Use below.
### B Indication(s) for Use:
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a fully automated multiplexed real-time polymerase chain reaction (RT-PCR) in vitro diagnostic test intended for the qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus (Flu A), influenza B virus (Flu B), and respiratory syncytial virus (RSV). Nucleic acids are isolated and purified from nasopharyngeal (NP) swab specimens and anterior nasal (AN) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza, and RSV can be similar. This assay is intended to aid in the differential diagnosis of SARS-CoV-2, Flu A, Flu B, and RSV infections in humans and is not intended to detect influenza C virus infections.
Nucleic acids from the viral organisms identified by this test are generally detectable in NP and AN swab specimens during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infection are indicative of the presence of the identified virus and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
Positive results do not rule out coinfection with other organisms. The organism(s) detected by the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus, or RSV infections. This assay is designed for use on the Panther Fusion system.
### C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
For in vitro diagnostic use only
K242465 - Page 2 of 15
{2}
D Special Instrument Requirements:
For use with the Panther Fusion System, only.
IV Device/System Characteristics:
A Device Description:
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a multiplex real-time reverse transcriptase PCR (RT-PCR) in vitro diagnostic test developed for use on the fully automated. Panther Fusion system to detect and differentiate SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) directly from nasopharyngeal and anterior nasal swab specimens.
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay cartridge contains the same sample preparation and PCR reaction chemistry as the previously cleared Panther Fusion Flu A/B/RSV assay (K171963). To accommodate addition of the SARS-CoV-2 reagents (primers/probes) to the multiplexed reagents, minor changes were made to the previously cleared analyte primer/probe concentrations and RFU cutoffs. Additionally, the fluorophore for Flu B was changed from ROX to RED647 to accommodate the addition of SARS-CoV-2 to the assay.
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay involves the following steps:
a. Sample lysis - Prior to processing and testing on the Panther Fusion system, specimens are transferred to a Specimen Lysis Tube (SLT) containing specimen transport media (STM). Alternatively, samples can be collected with the RespDirect Collection kit which contains enhanced specimen transport media (eSTM). STM and eSTM lyse the cells, release target nucleic acid and protect them from degradation during storage.
b. Nucleic acid capture and elution - These steps take place in a single tube on the Panther Fusion system. The eluate is transferred to the Panther Fusion system reaction tube containing the assay reagents. The Internal Control-S (IC-S) is added to each test specimen and controls via the working Panther Fusion Capture Reagent-S (wFCR-S). The IC-S in the reagent is used to monitor specimen processing, amplification, and detection. Magnetic particles with covalently bound oligonucleotides mediate the nucleic acid capture. Capture oligonucleotides hybridize to total nucleic acid in the test specimen. Hybridized nucleic acid is then separated from the lysed specimen in a magnetic field. Wash and aspiration steps remove extraneous components debris from the reaction tube. The elution step elutes purified nucleic acid.
c. Elution transfer and multiplex RT-PCR - Eluted nucleic acid is transferred to a Panther Fusion reaction tube already containing oil and reconstituted master mix. A reverse transcriptase generates a DNA copy of the target sequence. Target specific forward and reverse primers and probes then amplify targets while simultaneously detecting and discriminating multiple target types via multiplex RT-PCR. The Panther Fusion system compares the fluorescence signal to a predetermined cut-off to produce a qualitative result for the presence or absence of the analyte. The positive result for each analyte will be accompanied by the cycle threshold (Ct value).
Hologic RespDirect Collection Kit
An ancillary collection kit that consists of the RespDirect Swab, intended for collection of NP swab and AN swab specimens, and the enhanced Direct Load Tube (eDLT), containing enhanced specimen transport media (eSTM). This transport media lyses cells, releasing target nucleic acids and protects them from degradation during storage.
K242465 - Page 3 of 15
{3}
K242465 - Page 4 of 15
# B Principle of Operation:
The assay detects viral nucleic acids that have been extracted from a patient respiratory sample (i.e., NPS or AN swab specimens). A multiplex real-time RT-PCR reaction is carried out under optimized conditions generating amplicons for SARS-CoV-2, influenza A, influenza B, and RSV. The Internal Control-S (IC-S) is added to each test specimen before processing to act as a control for specimen processing, amplification, and detection. Identification of SARS-CoV-2, influenza A, influenza B, RSV, and the IC-S occurs using target-specific primers and fluorescent-labeled probes that hybridize to conserved regions in the viral genomes (Table 1).
Table 1. Assay Primer and Probe Targets
| Analyte | Gene Targeted | Instrument Channel |
| --- | --- | --- |
| SARS-CoV-2 | ORF1ab | ROX |
| Influenza A Virus | Matrix | FAM |
| Respiratory Syncytial Virus A/B | Matrix | HEX |
| Influenza B Virus | Matrix | RED647 |
| Internal Control-S | Not applicable* | RED677 |
*Internal Control-S is a non-infectious synthetic nucleic acid sequence that is extracted and detected through targeted primers and probes.
# C Instrument Description Information:
1. Instrument Name:
Panther System and Panther Fusion System, software version 7.2.7 or 7.2.9.
2. Specimen Identification:
Specimen identification is entered via barcode.
3. Specimen Sampling and Handling:
NPS and AN swab specimens collected in transport media.
4. Calibration:
Real Time Fluorometers (RTF) undergo a single calibration during manufacturing. No additional calibration is performed by the end user.
5. Quality Control:
The assay contains an internal control (IC-S) which is added to each test specimen via the working Panther Fusion Capture Reagent-S (wFCR-S). The IC-S is used to monitor specimen processing, amplification, and detection.
Two external controls are also included with this assay in a single use vial, the Panther Fusion SARS-CoV-2/Flu A/B/RSV Positive Control and the Panther Fusion Negative Control. The controls were validated in the analytical and clinical studies.
# V Substantial Equivalence Information:
## A Predicate Device Name(s):
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
## B Predicate 510(k) Number(s):
{4}
K241240
# C Comparison with Predicate(s):
| Device & Predicate Device(s): | K242465 (Subject) | K241240 (Predicate) |
| --- | --- | --- |
| Device Trade Name | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay |
| General Device Characteristic Similarities | | |
| Regulation Number/Name | Same | 21 CFR 866.3981 – Device To Detect And Identify Nucleic Acid Targets in Respiratory Specimens From Microbial Agents That Cause The SARS-Cov-2 Respiratory Infection And Other Microbial Agents When In A Multi-Target Test |
| Product Code(s) | Same | QOF, OOI |
| Prescription Use Only | Same | Yes |
| Platform | Same | Automated nucleic acid amplification platform. Uses Panther Fusion system for all steps including nucleic acid extraction, amplification, detection, and result processing |
| Technology/Principle of Operation | Same | Multiplexed polymerase chain reaction test |
| Assay Controls | Same | Internal and external controls |
| Time to Obtain Test Results | Same | ~ 2.5 hours |
| Patient Population | Same | Individuals with signs and symptoms of respiratory tract infection |
| Intended User | Same | Professional user |
| Organisms Detected | Same | SARS-CoV-2, Flu A, Flu B, RSV (RSV A and RSV B) |
| General Device Characteristic Differences | | |
| Intended Use | The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a fully automated multiplexed real-time polymerase chain reaction (RT-PCR) in vitro diagnostic test intended for the qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus (Flu A), influenza B virus (Flu B), and respiratory syncytial virus (RSV). Nucleic acids are isolated and purified from | The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a fully automated multiplexed real-time polymerase chain reaction (RT-PCR) in vitro diagnostic test intended for the qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus (Flu A), influenza B virus (Flu B), and respiratory syncytial virus (RSV). Nucleic acids are isolated and purified from |
K242465 - Page 5 of 15
{5}
K242465 - Page 6 of 15
| Device & Predicate Device(s): | K242465 (Subject) | K241240 (Predicate) |
| --- | --- | --- |
| | nasopharyngeal (NP) swab specimens and anterior nasal (AN) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza, and RSV can be similar. This assay is intended to aid in the differential diagnosis of SARS-CoV-2, Flu A, Flu B, and RSV infections in humans and is not intended to detect influenza C virus infections.
Nucleic acids from the viral organisms identified by this test are generally detectable in NP and AN swab specimens during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infection are indicative of the presence of the identified virus and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
Positive results do not rule out coinfection with other organisms. The organism(s) detected by the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus, or RSV infections. This assay is designed for use on the Panther Fusion system.
The Hologic RespDirect Collection Kit is cleared for NP swab specimens only for testing | nasopharyngeal (NP) swab specimens and anterior nasal (AN) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza, and RSV can be similar. This assay is intended to aid in the differential diagnosis of SARS-CoV-2, Flu A, Flu B, and RSV infections in humans and is not intended to detect influenza C virus infections.
Nucleic acids from the viral organisms identified by this test are generally detectable in NP and AN swab specimens during the acute phase of infection. The detection and identification of specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory tract infection are indicative of the presence of the identified virus and aids in diagnosis if used in conjunction with other clinical and epidemiological information, and laboratory findings. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
Positive results do not rule out coinfection with other organisms. The organism(s) detected by the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A virus, influenza B virus, or RSV infections. This assay is designed for use on the Panther Fusion system.
The Hologic RespDirect Collection Kit is cleared for NP swab specimens only for testing |
{6}
| Device & Predicate Device(s): | K242465 (Subject) | K241240 (Predicate) |
| --- | --- | --- |
| | | with the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. |
| Specimen Type/Transport Media Claims | • NPS in VTM/UTM or AN swab in VTM/UTM
• NPS in eSTM (RespDirect) or AN swab in eSTM (RespDirect) | • NPS in VTM/UTM or AN swab in VTM/UTM
• NPS in eSTM (RespDirect) |
| Adaptive Crosstalk Correction Implemented | Same | Yes |
VI Standards/Guidance Documents Referenced:
Standards
- CLSI EP12-A2. User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline – Second Edition.
- CLSI EP17-A2. Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition.
- CLSI EP25. Evaluation of Stability of In Vitro Medical Laboratory Test Reagents; Second Edition.
- CLSI EP37. Supplemental Tables for Interference Testing in Clinical Chemistry; First Edition.
- CLSI EP05-A3. Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition.
- CLSI MM13. Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Second Edition.
- CLSI EP07. Interference Testing in Clinical Chemistry; Third Edition.
- CLSI EP15-A3. User Verification of Precision and Estimation of Bias; Approved Guideline – Third Edition.
- CLSI EP24-A2. Assessment of the Diagnostic Accuracy of Laboratory Testing Using Receiver Operating Characteristic Curves; Approved Guideline – Second Edition.
- CLSI EP25-A. Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
Special Controls
Class II Special Controls as per 21 CFR 866.3981
FDA Guidance Documents
- Respiratory Viral Panel Multiplex Nucleic Acid Assay – Class II Special Controls Guidance for Industry and FDA Staff, October 9, 2009.
- Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], July 28, 2014.
- Guidance for Industry and FDA Staff: Content of Premarket Submissions for Device Software Functions, June 14, 2023.
- Guidance for Industry and Food and Drug Administration Staff: Electronic Submission Template for Medical Device 510(k) Submissions, October 2, 2023.
K242465 - Page 7 of 15
{7}
- Guidance for Industry and FDA Staff: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, September 27, 2023.
## VII Performance Characteristics (if/when applicable):
### A Analytical Performance:
Since the initial clearance of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (K222736), an Adaptive Crosstalk Correction (ACC) factor was implemented in the Assay Definition Module (ADM) software (K241240). No further device modifications have been introduced.
For those studies originally performed in K222736 and subsequently in K241240, there have been no device changes. Since there were no modifications to the assay (e.g., test reagent formulation, software, etc.), it was unnecessary to repeat several of the studies performed in support of K222736 or K241240. If a study was not repeated, a reference to where the results can be found (i.e., publicly available K222736 and K241240 Decision Summaries) has been made.
1. **Precision/Reproducibility:**
a. **Within-Laboratory Precision**
Please refer to the Within-Laboratory Precision Study data presented in the K222736 Decision Summary.
b. **Reproducibility**
Please refer to the Reproducibility Study data presented in the K222736 Decision Summary.
2. **Linearity:**
Not applicable; this is a qualitative assay.
3. **Analytical Specificity/Interference:**
**Analytical Reactivity (Inclusivity)**
a. **Wet-Testing**
Please refer to the Inclusivity Wet-Testing Study data presented in the K222736 Decision Summary.
b. **In silico**
Please refer to the Inclusivity *in silico* Study data presented in the K222736 Decision Summary.
**Exclusivity Testing**
Please refer to the Exclusivity Study data presented in the K222736 Decision Summary.
**Cross-Reactivity/Microbial Interference**
a. **Wet-Testing**
Please refer to the Cross-Reactivity/Microbial Interference Wet-Testing Study data presented in the K222736 Decision Summary.
K242465 - Page 8 of 15
{8}
b. In silico
Please refer to the Cross-Reactivity in silico Study data presented in the K222736 Decision Summary.
Interfering Substances
Please refer to the Interfering Substance Study data presented in the K222736 Decision Summary.
Competitive Interference
Please refer to the Interfering Substance Study data presented in the K222736 and K241240 Decision Summaries.
4. Assay Reportable Range:
Not applicable; this is a qualitative assay.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
a. Controls
The assay contains an internal control (IC-S) added to each test specimen and external positive and negative controls. For more information, see Section IV.C.5. Quality Control, above.
b. Sample Stability
Please refer to the Sample Stability Study data presented in the K222736 Decision Summary.
c. Kit Stability
Please refer to the Kit Stability Study data presented in the K222736 Decision Summary.
d. Shipping Stability
Please refer to the Shipping Stability Study data presented in the K222736 Decision Summary.
6. Detection Limit:
Please refer to the Limit of Detection Study data presented in the K222736 and K241240 Decision Summaries.
7. Assay Cut-Off:
Please refer to the Assay Cut-Off Study data presented in the K222736 Decision Summary.
8. Accuracy (Instrument):
Not applicable.
9. Carry-Over:
Please refer to the Carry-Over Study data presented in the K222736 Decision Summary.
B Comparison Studies:
1. Method Comparison with Predicate Device:
Not applicable.
K242465 - Page 9 of 15
{9}
2. Matrix Comparison:
Please refer to the Matrix Comparison Study data presented in the K222736 Decision Summary.
C Clinical Studies:
1. Clinical Sensitivity:
Prospective Study to Expand the Intended Use to Include an AN swab specimens collected using RespDirect Collection Kit in eSTM media Specimen Claim
The clinical performance of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay was established in a multi-center study conducted with two patient-matched paired AN swab specimens that were prospectively collected (i.e., all comers between two time points who meet the inclusion criteria) from individuals with signs and symptoms of respiratory tract infections from January 2023 to May 2023. One AN swab specimen was collected using the RespDirect Collection Kit with eSTM media for candidate device testing and the other AN swab specimen was collected using a synthetic flocked swab by a healthcare professional (HCP) and eluted in UTM/VTM for comparator testing. The collection order for candidate and comparator specimens was randomized. AN swab specimens from nine geographically diverse clinical sites in the U.S. were enrolled and tested fresh (Category I specimens) or frozen (Category II specimens) with the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay at three U.S. testing sites.
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay was evaluated for SARS-CoV-2 performance by comparing the candidate device testing results to a composite comparator algorithm (CCA) consisting of three highly sensitive U.S. FDA EUA SARS-CoV-2 molecular tests. A final CCA result was assigned when two of the three comparator assays were in concordance. The comparator method utilized to establish performance for the Flu A, Flu B, and RSV targets was a U.S. FDA-cleared molecular Flu A/B/RSV assay. All comparator testing was performed in accordance with the respective package inserts at one central laboratory.
A total of 1033 subjects (each providing patient-matched paired AN swab specimens) were acquired and enrolled for the prospective clinical study. Of these 1033 subjects, four were withdrawn because they did not meet the study eligibility criteria, leaving 1029 subjects. Of these 1029 subjects, 7 had their AN swab specimens excluded because they had an invalid candidate device result upon retesting and one specimen was withdrawn because the incorrect sample tube was used. Of the evaluable specimens, 1011 were test fresh (Category I specimens) with the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay and 10 were frozen (Category II specimens) prior to testing. Furthermore, two specimens were excluded for SARS-CoV-2 performance analysis due to invalid or inconclusive CCA results. This left 1019 prospective AN swab specimens (1009 fresh, 10 frozen) with evaluable results for SARS-CoV-2 and 1021 AN swab specimens (1011 fresh, 10 frozen) with evaluable results for Flu A, Flu B, and RSV.
K242465 - Page 10 of 15
{10}
Of the 1033 subjects enrolled in the study, 1032 had their AN swab specimens tested with the candidate device. Eleven (11) of these specimens were invalid by the candidate device during testing, for an initial invalid rate of $1.1\%$ (11/1032). Upon retesting, the invalid rate decreased to $0.7\%$ (7/1032).
Table 2 provides a summary of demographic information for the 1021 evaluable specimens included in the prospective clinical study.
Table 2. Demographic Data for Prospectively Collected, Evaluable AN Swab Specimens in eSTM (RespDirect)
| | | Overall N (%) |
| --- | --- | --- |
| Sex | Male | 427 (41.8%) |
| | Female | 594 (58.2%) |
| Age | <5 years | 18 (1.8%) |
| | 5-21 years | 120 (11.8%) |
| | 22-40 years | 386 (37.8%) |
| | 41-60 years | 319 (31.2%) |
| | >60 years | 178 (17.4%) |
| Total | | 1021 |
A summary of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay prospective clinical study performance is provided in Table 3.
Positive Percent Agreement (PPA) was calculated as $100\% \times (\mathrm{TP} / (\mathrm{TP} + \mathrm{FN}))$ . True positive (TP) indicates that both the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay and the comparator method had a positive result for the specific analyte, and false negative (FN) indicates that the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay was negative while the comparator result was positive. Negative Percent Agreement (NPA) was calculated as $100\% \times (\mathrm{TN} / (\mathrm{TN} + \mathrm{FP}))$ . True negative (TN) indicates that both the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay and the comparator method had negative results, and false positive (FP) indicates that the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay was positive while the comparator result was negative. Specimens that obtained discordant results for SARS-CoV-2 underwent additional testing with two U.S. FDA EUA SARS-CoV-2 molecular tests, and discordant results for Flu A, Flu B or RSV underwent additional testing with a U.S. FDA EUA SARS-CoV-2/Flu A/B/RSV molecular test, when sufficient sample volume remained.
Table 3. Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Performance with Prospectively Collected AN Swab Specimens in eSTM (RespDirect)
| Analyte | Specimen Type | Positive Percent Agreement | | | Negative Percent Agreement | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | TP/ (TP+FN) | % | 95% CI | TN/ (TN+FP) | % | 95% CI |
| SARS-CoV-2 | Fresh | 107/108 | 99.1 | 94.9-99.8 | 892/901 | 99.0 | 98.1-99.5 |
| | Frozen | 2/2 | 100 | 34.2-100 | 8/8 | 100 | 67.6-100 |
| | Overall | 109/110 | 99.1 | 95.0-99.8 | 900/9091 | 99.0 | 98.1-99.5 |
| Flu A | Fresh | 11/11 | 100 | 74.1-100 | 999/1000 | 99.9 | 99.4-99.9 |
| | Frozen | 0/0 | 0 | NC | 10/10 | 100 | 72.3-100 |
| | Overall | 11/11 | 100 | 74.1-100 | 1009/10102 | 99.9 | 99.4-100 |
K242465 - Page 11 of 15
{11}
| Flu B | Fresh | 5/6 | 83.3 | 43.6-97.0 | 1003/1005 | 99.8 | 99.3-100 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Frozen | 0/0 | 0 | NC | 10/10 | 100 | 72.3-100 |
| | Overall | 5/6³ | 83.3 | 43.6-97.0 | 1013/1015⁴ | 99.8 | 99.3-99.9 |
| RSV | Fresh | 1/1 | 100 | 20.7-100 | 1009/1010 | 99.9 | 99.4-100 |
| | Frozen | 0/0 | 0 | NC | 10/10 | 100 | 72.3-100 |
| | Overall | 1/1 | 100 | 20.7-100 | 1019/1020⁵ | 99.9 | 99.4-100 |
TP – true positive; FN – false negative; TN – true negative; FP – false positive; NC – Not calculable
¹Seven (7) specimens with false positive SARS-CoV-2 results had sufficient sample volume remaining for discordant testing. All were negative for SARS-CoV-2 by two different U.S. FDA EUA SARS-CoV-2 molecular tests.
²The specimen with a false positive Flu A result was negative for Flu A by a U.S. FDA EUA SARS-CoV-2/Flu A/B/RSV molecular test.
³The specimen with a false negative Flu B result was negative for Flu B by a U.S. FDA EUA SARS-CoV-2/Flu A/B/RSV molecular test.
⁴Both specimens with false positive Flu B results were negative for Flu B by a U.S. FDA EUA SARS-CoV-2/Flu A/B/RSV molecular test.
⁵The specimen with a false positive RSV result was negative for RSV by a U.S. FDA EUA SARS-CoV-2/Flu A/B/RSV molecular test.
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay reported one prospective, evaluable AN swab specimen in eSTM (RespDirect) with a co-infection (0.1% of all prospective specimens, 1/1021). The co-infection contained two pathogens, SARS-CoV-2 and Flu B. The sample was negative for all analytes by the comparator methods.
Data for prospective clinical study conducted with NP swab specimens and AN swab specimens in UTM/VTM are presented in the Decision Summaries for K222736 and K241240.
## Supplemental Clinical Data for Low Prevalence Analytes (Category III Specimens)
Flu A, Flu B and RSV were of lower prevalence and were not encountered in sufficiently large numbers during the prospective clinical study to adequately demonstrate assay performance with AN swab specimens collected with the RespDirect Collection Kit in eSTM media. To supplement the results of the prospective clinical study, an enrichment phase of the study was initiated which enrolled only symptomatic individuals who had obtained a Flu A, Flu B and/or RSV positive molecular standard of care (SOC) test within five days of enrollment. Enrichment occurred from October 2023- February 2024. One AN swab specimen was collected using the RespDirect Collection Kit with eSTM media for candidate device testing and the other AN swab specimen was collected using a synthetic flocked swab by a healthcare professional (HCP) and eluted in UTM/VTM for comparator testing. The collection order for candidate and comparator specimens was randomized. AN swab specimens from six geographically diverse clinical sites in the U.S. were enrolled and frozen prior to testing with the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay at one U.S. testing site. The same U.S. FDA-cleared molecular Flu A/B/RSV assay was used as the comparator method; SARS-CoV-2 was not evaluated during the enrichment phase of the study.
A total of 210 subjects (each providing patient-matched paired AN swab specimens) were acquired and enrolled for the enrichment phase of the clinical study. Of these 210 subjects, five were withdrawn because they did not meet the study eligibility criteria, and one additional subject chose to withdraw from the study leaving a total of 204 evaluable AN swab specimens in eSTM (RespDirect) from the enrichment phase.
Of the 210 subjects enrolled in the study, 205 had their AN swab specimens tested with the candidate device. Two (2) of these specimens were invalid by the candidate device during
K242465 - Page 12 of 15
{12}
testing, for an initial invalid rate of $1.0\%$ (2/205). Upon retesting, the invalid rate decreased to $0\%$ (0/205).
Table 4 provides a summary of demographic information for the 204 evaluable specimens included in the enrichment phase of the clinical study.
Table 4. Demographic Data for Evaluable AN Swab Specimens in eSTM (RespDirect) from Enrichment Phase
| | | Overall |
| --- | --- | --- |
| Sex | Male | 85 (41.7%) |
| | Female | 119 (58.3%) |
| Age | <5 years | 43 (21.1%) |
| | 5-21 years | 54 (26.5%) |
| | 22-40 years | 34 (16.7%) |
| | 41-60 years | 37 (18.1%) |
| | >60 years | 36 (17.6%) |
| Total | | 204 |
A summary of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay performance from the enrichment phase of the clinical study is provided in Table 5.
Table 5. Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay Performance with AN Swab Specimens in eSTM (RespDirect) from the Enrichment Phase
| Analyte | Positive Percent Agreement | | | Negative Percent Agreement1 | | |
| --- | --- | --- | --- | --- | --- | --- |
| | TP/(TP+FN) | % | 95% CI | TN/(TN+FP) | % | 95% CI |
| Flu A | 69/712 | 97.2 | 90.3-99.2 | 124/1333 | 93.2 | 87.6-96.4 |
| Flu B | 44/454 | 97.8 | 88.4-99.6 | 158/1595 | 99.4 | 96.5-99.9 |
| RSV | 60/616 | 98.4 | 91.3-99.7 | 137/1437 | 95.8 | 91.2-98.1 |
TP - true positive; FN - false negative; TN - true negative; FP - false positive
All samples enrolled in the enrichment study were SOC positive for Flu A, Flu B, and/or RSV. The NPA for the enrichment study was calculated using results from all evaluable samples with a negative comparator result for the analyte of interest.
2Both specimens with false negative Flu A results were positive for Flu A by a U.S. FDA EUA SARS-CoV-2/Flu A/B/RSV molecular test.
3One (1) of the 9 samples with a false positive Flu A results was positive for Flu A by a U.S. FDA EUA SARS-CoV-2/Flu A/B/RSV molecular test and 8 of the 9 samples were negative for Flu A.
4The sample with a false negative Flu B result was negative for Flu B by a U.S. FDA EUA SARS-CoV-2/Flu A/B/RSV molecular test.
5The sample with a false positive Flu B result was positive for Flu B by a by a U.S. FDA EUA SARS-CoV-2/Flu A/B/RSV molecular test.
6The sample with a false negative RSV result was negative for RSV by a U.S. FDA EUA SARS-CoV-2/Flu A/B/RSV molecular test.
7One (1) of the 6 samples with a false positive RSV results was positive for RSV by a U.S. FDA EUA SARS-CoV-2/Flu A/B/RSV molecular test and 5 of the 6 samples were negative for RSV.
As shown in Table 6, the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay reported 7 evaluable AN swab specimens in eSTM (RespDirect) in the enrichment phase with co-infections (3.4% of all enriched specimens, 7/204). All co-infections contained two pathogens, 4 contained Flu A and RSV, one contained SARS-CoV-2 and Flu A, one
K242465 - Page 13 of 15
{13}
contained SARS-CoV-2 and RSV and one contained Flu B and RSV. For the candidate results that were positive for Flu A and RSV, the comparator method did not detect RSV in two of the samples. The U.S. FDA cleared molecular assay used for the comparator for Flu A, Flu B and RSV does not detect SARS-CoV-2; therefore, co-infections detected by the candidate device that contained SARS-CoV-2 could not be confirmed.
Table 6. Co-infections Detected by the Panther Fusion SARS-CoV-2/ Flu A/B/RSV Assay in AN Swab Specimens during Enrichment Phase
| Co-Infection Combination | Number of Specimens | Discrepant Co-Infections^{1} |
| --- | --- | --- |
| Flu A + RSV | 4 | 2 |
| SARS-CoV-2 + Flu A | 1 | ND^{2} |
| SARS-CoV-2 + RSV | 1 | ND^{2} |
| Flu B + RSV | 1 | 0 |
| Total | 7 | 2 |
ND- Not determined.
1A discrepant co-infection was defined as a specimen that contains at least one pathogen detected by the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay which was not detected by the comparator method.
2The comparator method does not detect SARS-CoV-2. Coinfections detected by the candidate assay that include SARS-CoV-2 cannot be confirmed.
2. Clinical Specificity:
See section “Clinical Sensitivity” above.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.
D Clinical Cut-Off:
Not applicable.
E Expected Values/Reference Range:
The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay prospective clinical study included a total of 1033 prospectively collected AN swab specimens in eSTM (RespDirect), of which 1019 were evaluable for SARS-CoV-2 and 1021 were evaluable for Flu A, Flu B, and RSV. The number and percentage of cases positive for SARS-CoV-2, influenza A, influenza B, and RSV, as determined by the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay, are presented in Table 7, stratified by collection site.
Table 7. Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay – Expected Values by Specimen Collection Site for AN Swab Specimens in eSTM (RespDirect)
| Site | SARS-CoV-2 | Flu A | Flu B | RSV |
| --- | --- | --- | --- | --- |
| Total | 11.6%
(118/1019) | 1.2%
(12/1021) | 0.7%
(7/1021) | 0.2%
(2/1021) |
| Site 1 | 50.0%
(1/2) | 0%
(0/2) | 0%
(0/2) | 0%
(0/2) |
| Site 2 | 4.2%
(1/24) | 0%
(0/24) | 0%
(0/24) | 0%
(0/24) |
K242465 - Page 14 of 15
{14}
| Site 3 | 2.2%
(3/136) | 0.7%
(1/136) | 0%
(1/136) | 0%
(1/136) |
| --- | --- | --- | --- | --- |
| Site 4 | 15.3%
(42/275) | 0.4%
(1/276) | 0%
(0/276) | 0%
(0/276) |
| Site 5 | 18.6%
(34/183) | 0.5%
(1/183) | 0%
(1/183) | 0.5%
(1/183) |
| Site 6 | 7.7%
(2/26) | 0%
(0/26) | 0%
(0/26) | 0%
(0/26) |
| Site 7 | 19.3%
(16/83) | 1.2%
(1/84) | 2.4%
(2/84) | 0%
(0/84) |
| Site 8 | 2.5%
(4/160) | 3.1%
(5/160) | 1.9%
(3/160) | 0.6%
(1/160) |
| Site 9 | 11.5%
(15/130) | 2.3%
(3/130) | 1.5%
(2/130) | 0%
(0/130) |
F Other Supportive Instrument Performance Characteristics Data:
Not applicable.
VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K242465 - Page 15 of 15
Panel 1
/
Sort by
Ready
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
