(39 days)
Not Found
No
The device description focuses on real-time PCR technology and software analysis of fluorescence curves, with no mention of AI or ML. The performance studies describe standard analytical and clinical validation methods, not AI/ML model training or testing.
No.
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detection System is an in vitro diagnostic (IVD) device used for the qualitative detection of DNA sequences from Bacillus anthracis, providing presumptive identification for clinical diagnosis rather than a therapeutic intervention.
Yes
The device is explicitly stated to be an "in vitro diagnostic (IVD) detection" system intended for the "qualitative in vitro diagnostic (IVD) detection" of target DNA sequences for Bacillus anthracis, and its results are for "presumptive identification of B. anthracis".
No
The device description explicitly states that the system is composed of a portable JBAIDS instrument, laptop computer and software, and the JBAIDS Anthrax Detection Kit. This includes hardware components (instrument, laptop, kit) in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section: "The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detection System is a real-time polymerase chain reaction (PCR) test system intended for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences..."
Furthermore, the "Device Description" section also refers to it as a "fully integrated IVD system".
N/A
Intended Use / Indications for Use
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detection System is a real-time polymerase chain reaction (PCR) test system intended for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences on the pXO1 plasmid (Target 1) and the pXO2 plasmid (Target 2) from Bacillus anthracis. The system can be used to test the following:
- Human whole blood collected in sodium citrate from individuals suspected of having anthrax
- Positive blood cultures .
- Cultured organisms grown on blood agar plates. .
The JBAIDS Anthrax Target 2 assay is used as a supplementary test only after a positive result with the Target 1 Assay.
The JBAIDS Anthrax Target 1 and Target 2 Assays are run on the JBAIDS instrument using the Diagnostic Wizard. Results are for the presumptive identification of B. anthracis, in conjunction with culture and other laboratory tests. The following considerations also apply:
- The diagnosis of anthrax infection must be made based on history, signs, symptoms, . exposure likelihood, and other laboratory evidence, in addition to the identification of pXO1 and pXO2 targets either from cultures or from direct blood specimens.
- The assays have not been evaluated with blood from individuals without clinical signs . or symptoms who were presumed exposed and who subsequently developed anthrax (inhalation or other forms of the disease), or from individuals with any form of anthrax (inhalational, cutaneous, or gastrointestinal).
- The level of plasmid targets that would be present in blood from individuals with o early systemic infection is unknown.
- The definitive identification of B. anthracis from colony growth, liquid blood culture . growth, or from blood specimens requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required.
The safety and effectiveness of other types of tests or sample types (not identified as "For in vitro diagnostic use") have not been established.
Product codes
NHT
Device Description
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detection System is a fully integrated IVD system composed of the portable JBAIDS instrument, laptop computer and software, the JBAIDS Anthrax Detection Kit with two different freeze-dried PCR assays for detection of pathogenic Bacillus anthracis DNA. The system has been validated using four different sample preparation kits for isolating DNA from whole blood (IT 1-2-3TM Platinum Path, QFLOWdma, FLOW Sample Purification Kits), positive blood cultures (IT I-2-3TM SWIPE Sample Purification Kit), and plate cultures (IT 1-2-3™ Platinum Path and SWIPE Sample Purification Kits). Use of the JBAIDS DNA Extraction Control Kit is also recommended.
Prior to testing, specimens are processed using BioFire Diagnostic's IT 1-2-3 Sample Purification Kits. The resulting purified sample is added to Target 1 Unknown and Target 1 Inhibition Control vials, along with reconstitution buffer. Target 1 Positive Control and Negative Control vials are prepared using reconstitution buffer and water. When B. anthracis DNA is present, a fragment of B. anthracis DNA is amplified. The amplicon is detected by fluorescence using a specific hydrolysis probe. Each probe is labeled on one end with a fluorescent reporter moiety (6-carboxyfluorescein (6-FAM)) and elsewhere with a quencher moiety (carboxy tetramethylrhodamine (TAMRA)). When the probe is intact, the quencher absorbs the light emitted by the reporter moiety. During PCR, the probe hybridizes to the target sequence before the exonuclease activity of Taq polymerase hydrolyzes the probe, separating the fluorophore from the quencher and permitting detection of the fluorescent signal generated by the reporter. The fluorescent signal increases as additional templates are amplified and more probes are hydrolyzed.
JBAIDS Software analyzes the fluorescence amplification curves and reports results as positive, negative, uncertain or inhibited. A failure of the Positive or Negative Control will result in the entire run being called invalid. Retesting is required to resolve uncertain, invalid or inhibited results. The Target 2 assay is used as a supplementary test only after a positive result is obtained with the Target 1 assay.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Summary of Performance Data
Clinical Performance
True clinical specimens from patients infected with Bacillus anthracis (anthrax), are not available for testing due to the extreme rarity of natural infection with this organism. Therefore, a clinical evaluations using surrogate specimens was performed to validate the use of the IT 1-2-37M Platinum Path Sample Purification Kit for use with the JBAIDS Anthrax Detection Kit. Whole blood specimens were prospectively collected from patients with fever, after which the samples were spiked with inactivated B. anthracis, purified by both the new and old extraction methods, and then tested.
Testing of Surrogate Whole Blood Clinical Specimens
One hundred (100) surrogate whole blood specimens were prepared using prospectively collected specimens that were collected from febrile volunteers from November of 2012 into April of 2013. Fifty (50) of the specimens were spiked with inactivated B. anthracis at concentrations near and above the system LoD, while the remaining 50 specimens were not spiked with B. anthracis. Samples were then processed using both the new nucleic acid extraction method (Platinum Path) and the original nucleic acid extraction method (IT /-2-3TM QFLOWdad Sample Purification Kit; QFLOWdard by testing with the JBAIDS Anthrax Detection Kit. JBAIDS operators were blinded to the analyte content of the samples. Table 3 presents the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) for the surrogate whole blood speciment testing. The combined Target 1 and Target 2 results obtained with the Platinum Path processed samples were compared to the combined Target 1 and Target 2 results obtained with the QFLOWdia processed samples. The JBAIDS result for a sample purified using from the OFLOWdan kit was considered the correct result. The final Anthrax interpretation for samples purified using the Platinum Path kit had a positive percent agreement (PPA) of 100% as compared to samples purified using QFLOWdar (50/50; 95% CI = 92.9-100%). The final JBAIDS Anthrax interpretation for samples purified using Platinum Path was negative for 50 out of 50 samples that were negative when purified using QFLOWdna This represents a negative percent agreement (NPA) of 100% (50/50; 95% CI = 92.9-100%). The IT 1-2-3 OFLOWan and Platinum Path Sample Purification Kits performed equivalently with respect to detection of B. anthracis in surrogate whole blood specimens tested with the JBAIDS Anthrax Detection Kit.
Summary of Performance Studies
Clinical Performance: One hundred (100) surrogate whole blood specimens were prepared using prospectively collected specimens from febrile volunteers. Fifty (50) were spiked with inactivated B. anthracis, and 50 were not. Samples were processed using both Platinum Path (new) and QFLOWdna (original) nucleic acid extraction methods and tested with the JBAIDS Anthrax Detection Kit. JBAIDS operators were blinded.
Key Results:
- Positive Percent Agreement (PPA): 100% (50/50; 95% CI = 92.9-100%) for Platinum Path processed samples compared to QFLOWdna processed samples.
- Negative Percent Agreement (NPA): 100% (50/50; 95% CI = 92.9-100%) for Platinum Path processed samples compared to QFLOWdna processed samples.
- Conclusion: The IT 1-2-3 QFLOWdna and Platinum Path Sample Purification Kits performed equivalently.
Selected Analytic Studies:
Limit of Detection:
- Study Type: LoD Confirmation
- Sample Size: 20 independent whole blood specimens
- Key Results: 20/20 samples spiked with B. anthracis at 1000 CFU/mL (previously established LoD) were detected with the JBAIDS Anthrax Detection Kit after being processed with the IT 1-2-3 Platinum Path Sample Purification Kit.
- Anthrax Target 1: Mean Cp = 32.12 ± 0.54
- Anthrax Target 2: Mean Cp = 32.95 ± 0.66
Reproducibility:
- Study Type: Multicenter Study
- Sample Size: A panel of 12 blood samples was tested twice a day for four days at each of three testing sites (total of 96 replicates for each spike level per site).
- Test Panel: Four samples spiked at 5xLoD, four samples spiked at 1xLoD, and four unspiked samples.
- Key Results:
- Medium Positive (5xLoD) & Low Positive (1xLoD): 100% detection rate across all sites (Each 96/96 positive results). 95% CI = 96.2-100.
- Negative Samples: 100% agreement with expected result (0/96 positive results). 95% CI = 96.2-100.
- Conclusion: The JBAIDS Anthrax Detection System is reproducible when used with whole blood samples processed with the IT 1-2-3 Platinum Path Sample Purification Kit.
Detection of Direct Culture Samples Processed with the IT 1-2-3 Platinum Path Sample Purification Kit:
- Study Type: Detection Study
- Sample Size: 10 Bacillus anthracis colonies and 10 non-B. anthracis colonies.
- Key Results:
- B. anthracis: 10/10 colonies detected for both Target 1 and Target 2.
- Target 1: Mean Cp = 26.62, SD = 3.83
- Target 2: Mean Cp = 27.38, SD = 3.73
- Non-B. anthracis: 0/10 colonies detected for both Target 1 and Target 2.
- B. anthracis: 10/10 colonies detected for both Target 1 and Target 2.
Key Metrics
- Positive Percent Agreement (PPA): 100% (50/50; 95% CI = 92.9-100%)
- Negative Percent Agreement (NPA): 100% (50/50; 95% CI = 92.9-100%)
- Limit of Detection: 1000 CFU/mL in whole blood.
- Reproducibility: 100% agreement with expected result for spiked samples and negative samples (95% CI = 96.2-100).
- Detection rate for B. anthracis colonies processed with Platinum Path: 10/10 (100%).
- Detection rate for non-B. anthracis colonies processed with Platinum Path: 0/10 (0%).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3045 In vitro diagnostic device for
Bacillus spp. detection.(a)
Identification. An in vitro diagnostic device forBacillus species (spp.) detection is a prescription device used to detect and differentiate amongBacillus spp. and presumptively identifyB. anthracis and otherBacillus spp. from cultured isolates or clinical specimens as an aid in the diagnosis of anthrax and other diseases caused byBacillus spp. This device may consist ofBacillus spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to presumptively identify bacillus-like organisms in clinical specimens; bacteriophage used for differentiatingB. anthracis from otherBacillus spp. based on susceptibility to lysis by the phage; or antigens used to identify antibodies toB. anthracis (anti-toxin and anti-capsular) in serum. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused byB. anthracis, and gastrointestinal disease and non-gastrointestinal infections caused byB. cereus. (b)
Classification. Class II (special controls). The special controls are set forth in FDA's special controls guideline document entitled “In Vitro Diagnostic Devices forBacillus spp. Detection; Class II Special Controls Guideline for Industry and Food and Drug Administration Staff.” For availability of the guideline document, see § 866.1(e).(c)
Restriction on Distribution. The distribution of these devices is limited to laboratories that follow public health guidelines that address appropriate biosafety conditions, interpretation of test results, and coordination of findings with public health authorities.(d)
Restriction on Use. The use of this device is restricted to prescription use and must comply with the following:(1) The device must be in the possession of:
(i)(A) A person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or
(B) A practitioner, such as a physician, licensed by law to use or order the use of such device; and
(ii) The device must be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.
(2) The label of the device shall bear the statement “Caution: Federal law restricts this device to sale by or on the order of a ____”, the blank to be filled with the word “physician” or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device.
(3) Any labeling, as defined in section 201(m) of the Federal Food, Drug, and Cosmetic Act, whether or not it is on or within a package from which the device is to be dispensed, distributed by, or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or purports to furnish information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. This information will not be required on so-called reminder-piece labeling which calls attention to the name of the device but does not include indications or other use information.
(4) All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling.
0
K13/930
t
10 510(k) Summary
510(k) Summary BioFire Diagnostics, Inc.
Modification of the JBAIDS Anthrax Detection Kit for use with the IT 1-2-3™ Platinum Path Sample Purification Kit Accessory
Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitted by:
BioFire Diagnostics, Inc. 390 Wakara Way Salt Lake City, UT 84108
Telephone: 801-736-6354 Facsimile: 801-588-0507
Contact: Cynthia Phillips, ext. 370
Date Submitted: June 24, 2013
Device Name and Classification:
Trade Name: JBAIDS Anthrax Detection Kit Regulation Number: 21 CFR 866.3045 Classification Name: Reagent Kit: B. anthracis, Class II Product Code: NHT
Predicate Device:
JBAIDS Anthrax Detection Kit (K051713 and K071188)
Intended Use:
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detection System is a real-time polymerase chain reaction (PCR) test system intended for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences on the pXO1
BioFire Diagnostics, Inc. 510(k) JBAIDS Anthrax Detection Kit
AUG 0 5 2013
1
plasmid (Target 1) and the pXO2 plasmid (Target 2) from Bacillus anthracis. The system can be used to test the following:
- Human whole blood collected in sodium citrate from individuals suspected of having . anthrax
- Positive blood cultures .
- Cultured organisms grown on blood agar plates. .
The JBAIDS Anthrax Target 2 assay is used as a supplementary test only after a positive result with the Target 1 Assay.
The JBAIDS Anthrax Target 1 and Target 2 Assays are run on the JBAIDS instrument using the Diagnostic Wizard. Results are for the presumptive identification of B. anthracis, in conjunction with culture and other laboratory tests. The following considerations also apply:
- The diagnosis of anthrax infection must be made based on history, signs, symptoms, . exposure likelihood, and other laboratory evidence, in addition to the identification of pXO1 and pXO2 targets either from cultures or from direct blood specimens.
- The assays have not been evaluated with blood from individuals without clinical signs . or symptoms who were presumed exposed and who subsequently developed anthrax (inhalation or other forms of the disease), or from individuals with any form of anthrax (inhalational, cutaneous, or gastrointestinal).
- The level of plasmid targets that would be present in blood from individuals with o early systemic infection is unknown.
- The definitive identification of B. anthracis from colony growth, liquid blood culture . growth, or from blood specimens requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required.
The safety and effectiveness of other types of tests or sample types (not identified as "For in vitro diagnostic use") have not been established.
Device Description:
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detection System is a fully integrated IVD system composed of the portable JBAIDS instrument, laptop computer and software, the JBAIDS Anthrax Detection Kit with two different freeze-dried PCR assays for detection of pathogenic Bacillus anthracis DNA. The system has been validated using four different sample preparation kits for isolating DNA from whole blood (IT 1-2-3TM Platinum Path, QFLOWdma, FLOW Sample Purification Kits), positive blood cultures (IT I-2-3TM SWIPE Sample Purification Kit), and plate cultures (IT 1-2-3™ Platinum Path and SWIPE Sample Purification Kits). Use of the JBAIDS DNA Extraction Control Kit is also recommended.
Prior to testing, specimens are processed using BioFire Diagnostic's IT 1-2-3 Sample Purification Kits. The resulting purified sample is added to Target 1 Unknown and Target
2
1 Inhibition Control vials, along with reconstitution buffer. Target 1 Positive Control and Negative Control vials are prepared using reconstitution buffer and water. When B. anthracis DNA is present, a fragment of B. anthracis DNA is amplified. The amplicon is detected by fluorescence using a specific hydrolysis probe. Each probe is labeled on one end with a fluorescent reporter moiety (6-carboxyfluorescein (6-FAM)) and elsewhere with a quencher moiety (carboxy tetramethylrhodamine (TAMRA)). When the probe is intact, the quencher absorbs the light emitted by the reporter moiety. During PCR, the probe hybridizes to the target sequence before the exonuclease activity of Taq polymerase hydrolyzes the probe, separating the fluorophore from the quencher and permitting detection of the fluorescent signal generated by the reporter. The fluorescent signal increases as additional templates are amplified and more probes are hydrolyzed.
JBAIDS Software analyzes the fluorescence amplification curves and reports results as positive, negative, uncertain or inhibited. A failure of the Positive or Negative Control will result in the entire run being called invalid. Retesting is required to resolve uncertain, invalid or inhibited results. The Target 2 assay is used as a supplementary test only after a positive result is obtained with the Target 1 assay.
Substantial Equivalence:
The JBAIDS Anthrax Detection Kit is substantially equivalent to the previously cleared JBAIDS Anthrax Detection Kit. The following tables compare the modified JBAIDS Anthrax Detection Kit to the previously cleared JBAIDS Anthrax Detection Kits (K051713 and K071188). The first table outlines the similarities between the two systems and the following table outlines the differences.
| Element | New Device:
JBAIDS Anthrax Detection Kit with
addition of Platinum Path Sample
Purification Kit | Predicate:
JBAIDS Anthrax Detection Kit
(K051713 and K071188) | | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|--|--|
| Intended Use | Identification of anthrax infection
through the detection of two DNA
sequence targets, which are both
essential for Bacillus anthracis
pathogenicity. Results are used in
conjunction with clinical information,
culture, and other laboratory tests as an
aid in the diagnosis of systemic anthrax
infection in individuals suspected of
having the disease. | Same | | |
| Technology | Real-time PCR using hydrolysis probes | Same | | |
| Organism
Detected | Qualitative in vitro detection of Bacillus
anthracis DNA | Same | | |
| Specimen
Types | Whole blood (collected in 3.2% sodium
citrate), blood culture (grown in
soybean-casein digest broth) or
bacterial culture (grown on blood agar) | Same | | |
Table 1. Similarities between the New Device and the Predicate
3
| Element | New Device:
JBAIDS Anthrax Detection Kit with
addition of Platinum Path Sample
Purification Kit | Predicate:
JBAIDS Anthrax Detection Kit
(K051713 and K071188) |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Platform | JBAIDS Instrument | Same |
| Time Required
for Analysis of
Specimen | Less than 3 hours | Same |
Table 2. Differences between the New Device and the Predicate
| Element | New Device:
JBAIDS Anthrax Detection Kit with
addition of Platinum Path Sample
Purification Kit | Predicate:
JBAIDS Anthrax Detection Kit
(K051713 and K071188) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| DNA
Extraction
Methods | Whole blood purified with IT 1-2-3TM
Platinum Path or IT 1-2-3TM QFLOWdna
Sample Purification Kits (or validated
equivalent). | Whole blood purified with IT 1-2-3TM
QFLOWdna Sample Purification Kit (or
validated equivalent). |
| | Blood culture purified with IT 1-2-3TM
SWIPE Sample Purification Kit (or
validated equivalent). | Same |
| | Direct bacterial culture purified with IT
1-2-3TM Platinum Path or IT 1-2-3TM
SWIPE Sample Purification Kit (or
validated equivalent). | Direct bacterial culture purified with IT
1-2-3TM SWIPE Sample Purification Kit
(or validated equivalent). |
Summary of Performance Data
Clinical Performance
True clinical specimens from patients infected with Bacillus anthracis (anthrax), are not available for testing due to the extreme rarity of natural infection with this organism. Therefore, a clinical evaluations using surrogate specimens was performed to validate the use of the IT 1-2-37M Platinum Path Sample Purification Kit for use with the JBAIDS Anthrax Detection Kit. Whole blood specimens were prospectively collected from patients with fever, after which the samples were spiked with inactivated B. anthracis, purified by both the new and old extraction methods, and then tested.
Testing of Surrogate Whole Blood Clinical Specimens
One hundred (100) surrogate whole blood specimens were prepared using prospectively collected specimens that were collected from febrile volunteers from November of 2012 into April of 2013. Fifty (50) of the specimens were spiked with inactivated B. anthracis at concentrations near and above the system LoD, while the remaining 50 specimens were not spiked with B. anthracis. Samples were then processed using both the new
4
nucleic acid extraction method (Platinum Path) and the original nucleic acid extraction method (IT /-2-3TM QFLOWdad Sample Purification Kit; QFLOWdard by testing with the JBAIDS Anthrax Detection Kit. JBAIDS operators were blinded to the analyte content of the samples. Table 3 presents the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) for the surrogate whole blood speciment testing. The combined Target 1 and Target 2 results obtained with the Platinum Path processed samples were compared to the combined Target 1 and Target 2 results obtained with the QFLOWdia processed samples. The JBAIDS result for a sample purified using from the OFLOWdan kit was considered the correct result. The final Anthrax interpretation for samples purified using the Platinum Path kit had a positive percent agreement (PPA) of 100% as compared to samples purified using QFLOWdar (50/50; 95% CI = 92.9-100%). The final JBAIDS Anthrax interpretation for samples purified using Platinum Path was negative for 50 out of 50 samples that were negative when purified using QFLOWdna This represents a negative percent agreement (NPA) of 100% (50/50; 95% CI = 92.9-100%). The IT 1-2-3 OFLOWan and Platinum Path Sample Purification Kits performed equivalently with respect to detection of B. anthracis in surrogate whole blood specimens tested with the JBAIDS Anthrax Detection Kit.
Table 3. JBAIDS Anthrax Detection Kit Performance on Spiked Whole Blood Samples Processed with the IT 1-2-3 Platinum Path and QFLOWdas Sample Purification Kits
| Positive Agreement | Negative Agreement | ||||||
|---|---|---|---|---|---|---|---|
| QFLOW + | |||||||
| Platinum | |||||||
| Path + | QFLOW + | ||||||
| Platinum | |||||||
| Path - | PPA | 95% CI² | QFLOW - | ||||
| Platinum | |||||||
| Path - | QFLOW - | ||||||
| Platinum | |||||||
| Path + | NPA | 95% CI | |||||
| 50 | 0 | 100% | |||||
| (50/50) | 92.9- | ||||||
| 100% | 50 | 0 | 100% | ||||
| (50/50) | 92.9- | ||||||
| 100% |
ª C.J. Clopper and E.S. Pearson. 1934. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 26:404-413.
Selected Analytic Studies
Limit of Detection
Twenty out of 20 independent whole blood specimens spiked with B. anthracis at the previously established LoD level and processed with the IT 1-2-3 Platinum Path Sample Purification Kit were detected with the JBAIDS Anthrax Detection Kit. This confirmed the LoD of 1000 CFU/mL in whole blood that was originally established for whole blood samples processed using the IT I-2-3 FLOW Sample Purification Kit and later confirmed with the OFLOWana Sample Purification Kit.
| Table 4. Confirmation of the B. anthracis LoD for Platinum Path-Purified Whole Blood Samples | |
|---|---|
| Tested with the JBAIDS Anthrax Detection Kit |
| Anthrax Assay | Spiked B. anthracis
Concentration
(CFU/mL) | #
Positive | %
Positive | Anthrax Target Assay
Mean Cp
+/- Std Dev |
|---------------|--------------------------------------------------|---------------|---------------|------------------------------------------------|
| Target 1 | 1000 | 20/20 | 100.0% | 32.12 ± 0.54 |
| Target 2 | 1000 | 20/20 | 100.0% | 32.95 ± 0.66 |
5
Reproducibility
A multicenter study was performed to determine the overall system reproducibility when whole blood samples were processed with the IT I-2-3 Platinum Path Sample Purification Kit prior to testing with the JBAIDS Anthrax Detection Kit. A panel of 12 blood samples was tested twice each day for four days at each of three testing sites. The panel contained four samples spiked with inactivated B. anthracis Ames strain at a medium positive (5×LoD) level, four samples spiked at a low positive level (1×LoD), and four samples that were not spiked. Results are summarized in Table 5. The detection rate was 100% for all samples containing B. anthracis spiked near or above the LoD, and there were no false positive results for unspiked samples. The JBAIDS Anthrax Detection System is reproducible when used to test whole blood samples processed with the IT 1-2-3 Platinum Path Sample Purification Kit.
Table 5. Reproducibility of the Anthrax Target 2 Assays in the JBAIDS Anthrax Detection Kit for Whole Blood Samples Purified with the IT 1-2-3 Platinum Path Purification Kit
| Blood Spike Level | Test Location | Number Positive | Number Negative | % Agreement with Expected Result | 95% CI | Anthrax Target 1 | Number Positive | Number Negative | % Agreement with Expected Result | 95% CI | Anthrax Target 2 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean Cp | Std Dev | %CV | Mean Cp | Std Dev | %CV | ||||||||||
| Medium Positive | |||||||||||||||
| (5xLoD) | Site 1 | 32/32 | 0/32 | 100% | 31.59 | 0.79 | 2.50 | 32/32 | 0/32 | 100% | 31.86 | 0.71 | 2.23 | ||
| Site 2 | 32/32 | 0/32 | 100% | 31.70 | 0.90 | 2.84 | 32/32 | 0/32 | 100% | 31.96 | 0.73 | 2.28 | |||
| Site 3 | 32/32 | 0/32 | 100% | 30.24 | 0.73 | 2.41 | 32/32 | 0/32 | 100% | 30.81 | 0.74 | 2.40 | |||
| All Sites | 96/96 | 0/96 | 100% | 96.2-100 | 31.18 | 1.05 | 3.37 | 96/96 | 0/96 | 100% | 96.2-100 | 31.54 | 0.89 | 2.82 | |
| Low Positive | |||||||||||||||
| (1xLoD) | Site 1 | 32/32 | 0/32 | 100% | 34.31 | 0.76 | 2.22 | 32/32 | 0/32 | 100% | 34.35 | 0.87 | 2.53 | ||
| Site 2 | 32/32 | 0/32 | 100% | 34.21 | 0.83 | 2.43 | 32/32 | 0/32 | 100% | 34.41 | 0.78 | 2.27 | |||
| Site 3 | 32/32 | 0/32 | 100% | 32.78 | 0.55 | 1.68 | 32/32 | 0/32 | 100% | 33.29 | 0.57 | 1.71 | |||
| All Sites | 96/96 | 0/96 | 100% | 96.2-100 | 33.77 | 1.00 | 2.96 | 96/96 | 0/96 | 100% | 96.2-100 | 34.02 | 0.91 | 2.67 | |
| Negative | Site 1 | 0/32 | 32/32 | 100% | 0/32 | 32/32 | 100% | ||||||||
| Site 2 | 0/32 | 32/32 | 100% | 0/32 | 32/32 | 100% | |||||||||
| Site 3 | 0/32 | 32/32 | 100% | 0/32 | 32/32 | 100% | |||||||||
| All Sites | 0/96 | 96/96 | 100% | 96.2-100 | 0/96 | 96/96 | 100% | 96.2-100 |
Detection of Direct Culture Samples Processed with the IT 1-2-3 Platinum Path Sample Purification Kit
B. anthracis colonies can be detected using a Platinum Path protocol to process the colonies followed by testing with the JBAIDS Anthrax Detection Kit. Ten Bacillus anthracis colonies were purified alongside ten non- B. anthracis colonies. All ten B. anthracis colonies were detected with the JBAIDS Anthrax Detection Kit, while the non-B. anthracis colonies were not detected.
6
| Colony Type | Anthrax Target 1 | Anthrax Target 2 | ||||
|---|---|---|---|---|---|---|
| Positive Results/Total | Cp (cycles) Mean | SD | Positive Results/Total | Cp (cycles) Mean | SD | |
| B. anthracis | 10/10 | 26.62 | 3.83 | 10/10 | 27.38 | 3.73 |
| Non- B. anthracis | 0/10 | - | - | 0/10 | - | - |
Table 6. Anthrax Target 1 and Target 2 Detection from Colonies Purified with Platinum Path
.
مراجع
:
:
7
Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing or being embraced, with flowing lines suggesting movement or support.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
CYNTHIA PHILLIPS, Ph.D. MANAGER, JBAIDS REGULATED PRODUCTS BIOFIRE DIAGNOSTICS, INC. 390 WAKARA WAY SALT LAKE CITY UT 84108
August 5, 2013
Re: K131930
Trade/Device Name: JBAIDS Anthrax Detection Kit Regulation Number: 21 CFR 866.3045 Regulation Name: In vitro diagnostic device for Bacillus spp. detection Regulatory Class: II Product Code: NHT Dated: June 24, 2013 Received: June 27, 2013
Dear Dr. Phillips:
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 mislcading.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device ean be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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Page 2-Dr. Phillips
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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Uwe Scherf -5 for
Sally A. Hojvat, M.Sc., Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K131930 Device Name: JBAIDS Anthrax Detection System
The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detection System is a real-time polymerase chain reaction (PCR) test system intended for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences on the pXO1 plasmid (Target 1) and the pXO2 plasmid (Target 2) from Bacillus anthracis. The system can be used to test the following:
- . Human whole blood collected in sodium citrate from individuals suspected of having anthrax
- Positive blood cultures .
- Cultured organisms grown on blood agar plates. .
The JBAIDS Anthrax Target 2 assay is used as a supplementary test only after a positive result with the Target 1 Assay.
The JBAIDS Anthrax Target 1 and Target 2 Assays are run on the JBAIDS instrument using the Diagnostic Wizard. Results are for the presumptive identification of B. anthracis, in conjunction with culture and other laboratory tests. The following considerations also apply:
- The diagnosis of anthrax infection must be made based on history, signs, symptoms, . exposure likelihood, and other laboratory evidence, in addition to the identification of pX01 and pXO2 targets either from cultures or from direct blood specimens.
- . The assays have not been evaluated with blood from individuals without clinical signs or symptoms who were presumed exposed and who subsequently developed anthrax (inhalation or other forms of the disease), or from individuals with any form of anthrax (inhalational, cutaneous, or gastrointestinal).
- The level of plasmid targets that would be present in blood from individuals with . early systemic infection is unknown.
- The definitive identification of B. anthracis from colony growth, liquid blood culture . growth, or from blood specimens requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required.
The safety and effectiveness of other types of tests or sample types (not identified as "For in vitro diagnostic use") have not been established.
| Prescription Use
| Carlos Career Carollar Career Career Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Ca | AND/OR Over-The-Counter Use |
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| (Part 21 CFR 801 Subpart D) | 1 (21 CFR 801 Subpart C) |
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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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