(39 days)
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 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.
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.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating equivalence of a new DNA extraction method (Platinum Path) to an existing one (QFLOWdna) for use with the JBAIDS Anthrax Detection Kit. Therefore, the "acceptance criteria" are implicitly defined by the performance of the predicate device with the QFLOWdna kit, and the "reported device performance" is how the new Platinum Path kit compares.
| Performance Metric | Acceptance Criteria (Implicit from Predicate/QFLOWdna) | Reported Device Performance (with Platinum Path) |
|---|---|---|
| Clinical Performance (Surrogate Whole Blood) | ||
| Positive Percent Agreement (PPA) | Equivalent to QFLOWdna (presumably near 100% for positive samples) | 100% (50/50; 95% CI = 92.9-100%) |
| Negative Percent Agreement (NPA) | Equivalent to QFLOWdna (presumably near 100% for negative samples) | 100% (50/50; 95% CI = 92.9-100%) |
| Limit of Detection (LoD) | Previously established LoD of 1000 CFU/mL in whole blood (for Target 1 and Target 2) | 1000 CFU/mL (20/20 detected for both targets) |
| Reproducibility | Consistent performance across sites for medium positive, low positive, and negative samples | 100% agreement with expected results for all sites and spike levels, for both Target 1 and Target 2 |
| Direct Culture Samples (B. anthracis) | 100% detection of B. anthracis colonies | 10/10 B. anthracis colonies detected |
| Direct Culture Samples (Non-B. anthracis) | 0% detection of non-B. anthracis colonies | 0/10 non-B. anthracis colonies detected |
2. Sample Size Used for the Test Set and Data Provenance
-
Clinical Performance (Surrogate Whole Blood):
- Sample Size: 100 surrogate whole blood specimens (50 spiked with B. anthracis, 50 not spiked). Each sample was processed by both new (Platinum Path) and old (QFLOWdna) extraction methods and then tested.
- Data Provenance: Prospectively collected from febrile volunteers in the USA (November 2012 to April 2013). These were surrogate specimens spiked with inactivated B. anthracis, not true clinical anthrax samples.
-
Limit of Detection:
- Sample Size: 20 independent whole blood specimens, each spiked with B. anthracis at the LoD level.
- Data Provenance: Not explicitly stated, but implied to be laboratory-prepared samples for analytical validation.
-
Reproducibility:
- Sample Size: A panel of 12 blood samples (4 medium positive, 4 low positive, 4 negative). Each sample was tested twice a day for four days at each of three testing sites. Total individual tests for each target would be 12 samples * 2 tests/day * 4 days * 3 sites = 288 for each target (Target 1 and Target 2).
- Data Provenance: Multicenter study, locations are "Site 1, Site 2, Site 3." Country of origin not explicitly stated, but typically assumed to be domestic for FDA submissions unless otherwise specified.
-
Detection of Direct Culture Samples:
- Sample Size: 10 B. anthracis colonies and 10 non-B. anthracis colonies.
- Data Provenance: Not explicitly stated, but implied to be laboratory-prepared cultures.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The ground truth for the surrogate clinical specimens and analytical studies was established by:
- Spiking Status: Knowing which samples were spiked with inactivated B. anthracis and at what concentration, and which were not. This is a controlled laboratory process, not dependent on human expert interpretation for definitive classification.
- Predicate Device Performance: For the surrogate clinical specimens, the "correct result" was defined by the JBAIDS result when processed with the QFLOWdna kit, which is the predicate/established method. This avoids the need for external expert consensus on the B. anthracis status of a sample that has already been spiked.
Therefore, no external clinical experts were used to establish the ground truth in the traditional sense for these studies. The ground truth was based on the controlled spiking of samples and comparison to an established method.
4. Adjudication Method for the Test Set
Not applicable in the traditional sense. The "ground truth" for the surrogate clinical specimens was determined by the results from the predicate extraction method (QFLOWdna), and for the analytical studies, it was determined by the known spiking status of the samples. There was no need for expert adjudication of conflicting results as the comparison was against a predetermined "truth."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a molecular diagnostic test for B. anthracis DNA, not an imaging device that would typically involve human readers interpreting images. The study focuses on the analytical and clinical (surrogate) performance of the extraction method and PCR kit.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are standalone (algorithm only). The JBAIDS system, with its software, analyzes the fluorescence amplification curves and reports results (positive, negative, uncertain, inhibited). The operators were blinded to the analyte content, meaning their human "interpretation" was limited to running the instrument and following its automated output. The performance metrics (PPA, NPA, LoD, reproducibility) are based directly on the device's output.
7. The Type of Ground Truth Used
- Clinical Performance (Surrogate Whole Blood): Known spiking status of the samples from a laboratory perspective, and the performance of the predicate DNA extraction method (QFLOWdna) as the "correct result" for comparison.
- Limit of Detection: Known concentration of spiked B. anthracis in laboratory-prepared whole blood specimens.
- Reproducibility: Known concentration of spiked B. anthracis (medium, low, or unspiked).
- Detection of Direct Culture Samples: Known identity of the bacterial colonies (either B. anthracis or non-B. anthracis) through laboratory culture and identification.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" for the device itself. This submission is for modifications to an existing device (the JBAIDS Anthrax Detection Kit) by adding compatibility with a new sample purification kit (IT 1-2-3 Platinum Path). The JBAIDS system and its algorithm were presumably developed and validated previously. The studies described here are a validation of the new sample preparation method, not the training of a new algorithm.
9. How the Ground Truth for the Training Set Was Established
Since there is no explicit mention of a "training set" for a new algorithm within this submission, this question is not directly applicable. The JBAIDS Anthrax Detection System already existed and was previously cleared (K051713 and K071188). The ground truth for its initial development and validation would have followed similar principles of known positive and negative samples, likely through spiking and confirmed cultures, as is typical for molecular diagnostic assays.
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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
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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
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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 withaddition of Platinum Path SamplePurification Kit | Predicate:JBAIDS Anthrax Detection Kit(K051713 and K071188) | ||
|---|---|---|---|---|
| Intended Use | Identification of anthrax infectionthrough the detection of two DNAsequence targets, which are bothessential for Bacillus anthracispathogenicity. Results are used inconjunction with clinical information,culture, and other laboratory tests as anaid in the diagnosis of systemic anthraxinfection in individuals suspected ofhaving the disease. | Same | ||
| Technology | Real-time PCR using hydrolysis probes | Same | ||
| OrganismDetected | Qualitative in vitro detection of Bacillusanthracis DNA | Same | ||
| SpecimenTypes | Whole blood (collected in 3.2% sodiumcitrate), blood culture (grown insoybean-casein digest broth) orbacterial culture (grown on blood agar) | Same |
Table 1. Similarities between the New Device and the Predicate
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| Element | New Device:JBAIDS Anthrax Detection Kit withaddition of Platinum Path SamplePurification Kit | Predicate:JBAIDS Anthrax Detection Kit(K051713 and K071188) |
|---|---|---|
| Platform | JBAIDS Instrument | Same |
| Time Requiredfor Analysis ofSpecimen | Less than 3 hours | Same |
Table 2. Differences between the New Device and the Predicate
| Element | New Device:JBAIDS Anthrax Detection Kit withaddition of Platinum Path SamplePurification Kit | Predicate:JBAIDS Anthrax Detection Kit(K051713 and K071188) |
|---|---|---|
| DNAExtractionMethods | Whole blood purified with IT 1-2-3TMPlatinum Path or IT 1-2-3TM QFLOWdnaSample Purification Kits (or validatedequivalent). | Whole blood purified with IT 1-2-3TMQFLOWdna Sample Purification Kit (orvalidated equivalent). |
| Blood culture purified with IT 1-2-3TMSWIPE Sample Purification Kit (orvalidated equivalent). | Same | |
| Direct bacterial culture purified with IT1-2-3TM Platinum Path or IT 1-2-3TMSWIPE Sample Purification Kit (orvalidated equivalent). | Direct bacterial culture purified with IT1-2-3TM 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
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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 +PlatinumPath + | QFLOW +PlatinumPath - | PPA | 95% CI² | QFLOW -PlatinumPath - | QFLOW -PlatinumPath + | 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. anthracisConcentration(CFU/mL) | #Positive | %Positive | Anthrax Target AssayMean 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 |
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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.
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| 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
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مراجع
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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 UseCarlos 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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§ 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.