The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Tularemia Detection Kit is a real-time polymerase chain reaction (PCR) test kit intended for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences of Francisella tularensis. The system can be used to test human whole blood collected in sodium citrate or sputum collected aseptically from individuals greater than 18 years of age suspected of having tularemia. In addition, positive blood cultures and colonies may be tested. This assay is intended to aid in the diagnosis of individual presenting with signs and symptoms of pneumonic or typhoidal tularemia. It is not intended to aid in the diagnosis of glandular, ulceroglandular, oculoglandular, or oropharyngeal tularemia.

The JBAIDS Tularemia Detection Kit is run on the JBAIDS instrument using the Diagnostic Wizard. Results are for the presumptive identification of F. tularensis in conjunction with culture and other laboratory tests. The definitive identification of F. tularensis from colony growth. liguid blood culture growth, blood specimens, or sputum specimens requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required.

The diagnosis of tularemia must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence in addition to the identification of the target either from colonies, blood culture whole blood or sputum specimens.

The JBAIDS Tularemia Detection Kit is intended for use by trained clinical laboratory personnel who have received specific training on the use of the JBAIDS Tularemia Detection Kit. The level of F. tularensis that would be present in blood or sputum from individuals with early systemic or pneumonic infection is unknown. Due to the difficulty in obtaining clinical specimens, this assay was not evaluated with blood or sputum from individuals presenting with signs and symptoms of tularemia who have subsequently developed pneumonic or typhoidal tularemia pneumonic or typhoidal tularemia.

Device Description

The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Tularemia Detection System is a fully integrated IVD system composed of the portable JBAIDS instrument, laptop computer and software and the JBAIDS Tularemia Detection Kit with one freeze-dried PCR assay for detection of Francisella tularensis DNA. The system has been validated using four different sample preparation kits for isolating DNA from whole blood (IT /-2-3TM Platinum Path and QFLOWana Sample Purification Kits), sputum (IT I-2-3TM Platinum Path and IT 1-2-3TM VIBE Sample Purification Kits), positive blood cultures (IT 1-2-3 TM SWIPE Sample Purification Kit), and plate cultures (IT /-2-3TM Platinum Path and IT 1-2-3TM 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 I-2-3 Sample Purification Kits. The resulting purified sample is added to Unknown and Inhibition Control vials, along with reconstitution buffer. Positive Control and Negative Control vials are prepared using reconstitution buffer and water. When F. tularensis DNA is present, a fragment of F. tularensis 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 tetramethyIrhodamine (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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the JBAIDS Tularemia Detection Kit, based on the provided text:

Acceptance Criteria and Device Performance

The study aimed to demonstrate that the modified JBAIDS Tularemia Detection Kit, when used with the IT 1-2-3™ Platinum Path Sample Purification Kit, performs equivalently to the predicate device (JBAIDS Tularemia Detection Kit) using its established sample purification methods. The acceptance criteria are implicitly defined by achieving high agreement (PPA and NPA) with the results obtained from the predicate methods for surrogate clinical specimens and confirming Limit of Detection (LoD).

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (Platinum Path)
Whole Blood: Positive Percent Agreement (PPA) vs. QFLOWdna processed samples	High PPA (e.g., in the range of 95-100%)	100% (50/50), 95% CI = 92.9-100%
Whole Blood: Negative Percent Agreement (NPA) vs. QFLOWdna processed samples	High NPA (e.g., in the range of 95-100%)	100% (50/50), 95% CI = 92.9-100%
Sputum: Positive Percent Agreement (PPA) vs. VIBE processed samples	High PPA (e.g., in the range of 95-100%)	100% (49/49), 95% CI = 92.8-100%
Sputum: Negative Percent Agreement (NPA) vs. VIBE processed samples	High NPA (e.g., in the range of 95-100%)	96.1% (49/51), 95% CI = 86.5-99.5%
LoD for Whole Blood	100% detection at the established LoD	1500 CFU/mL: 20/20 (100.0%) detected
LoD for Sputum	≥95% detection at the established LoD	2000 CFU/mL: 19/20 (95.0%) detected
Reproducibility (Whole Blood - Medium Positive)	100% agreement with expected results in a multicenter study	100% (96/96) across all sites
Reproducibility (Whole Blood - Low Positive)	Expected strong agreement, acknowledges potential for variability near LoD (observed 86.5% overall due to likely under-spiking to 0.5x LoD)	86.5% (83/96) overall across all sites
Reproducibility (Whole Blood - Negative)	100% agreement with expected results in a multicenter study	100% (96/96) across all sites
Reproducibility (Sputum - Medium Positive)	100% agreement with expected results in a multicenter study	100% (90/90) across all sites
Reproducibility (Sputum - Low Positive)	≥95% agreement with expected results in a multicenter study	97.8% (88/90) overall across all sites
Reproducibility (Sputum - Negative)	100% agreement with expected results in a multicenter study	100% (90/90) across all sites
Direct Culture Detection (F. tularensis)	100% detection	10/10 detected
Direct Culture Detection (Non-F. tularensis)	0% detection	0/10 detected

Study Details

Sample Size and Data Provenance for Test Set:
- Whole Blood Surrogate Specimens (Clinical Performance): 100 specimens (50 spiked with inactivated F. tularensis, 50 unspiked).
  - Data Provenance: Prospectively collected from febrile volunteers from November 2012 to April 2013. The country of origin is not specified, but the submission is to the U.S. FDA.
- Sputum Surrogate Specimens (Clinical Performance): 100 specimens (50 spiked with inactivated F. tularensis, 50 unspiked).
  - Data Provenance: Frozen residual sputum specimens. The country of origin is not specified.
- Limit of Detection (LoD) - Whole Blood: 20 independent whole blood specimens.
- Limit of Detection (LoD) - Sputum: 20 independent sputum specimens.
- Reproducibility (Whole Blood): A panel of 12 distinct samples, tested twice a day for 4 days at 3 sites (total 96 observations per category for positive/negative conclusions). Effectively, 4 medium positive, 4 low positive, and 4 negative samples were used.
- Reproducibility (Sputum): A panel of 9 distinct samples, tested twice a day for 5 days at 3 sites (total 90 observations per category for positive/negative conclusions). Effectively, 3 medium positive, 3 low positive, and 3 negative samples were used.
- Direct Culture Detection: 10 F. tularensis colonies and 10 non-F. tularensis colonies.
Number of Experts and Qualifications for Ground Truth:
The document does not mention the use of human experts to establish ground truth for the test sets in the typical sense of clinical expert review. For the "clinical performance" studies, the ground truth was established by:
- Spiking: Preparing specimens by spiking with inactivated F. tularensis at known concentrations (for positive samples) or leaving them unspiked (for negative samples).
- Comparison to Predicate: The results from the existing, cleared sample purification methods (QFLOWdna for whole blood, VIBE for sputum) were considered the "correct result" a comparative effectiveness study, implying these methods served as the de facto reference standard for comparison with the new Platinum Path method.
Adjudication Method for Test Set:
No formal adjudication method (e.g., 2+1, 3+1) is described for resolving discrepancies, as the "ground truth" was largely established by the known spiked status of the samples or by the result from the predicate device's processing method. The JBAIDS system itself reports "uncertain" results, which require retesting by the trained laboratory personnel.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done to assess how human readers improve with AI vs. without AI assistance. This device is an in vitro diagnostic (IVD) PCR test kit, not an AI-assisted diagnostic imaging or interpretative technology for human readers. However, a multicenter reproducibility study was performed with JBAIDS operators, effectively involving multiple readers/sites, but not in the context of comparing human performance with and without AI.
Standalone Performance (Algorithm Only):
Yes, this study primarily assesses the standalone performance of the JBAIDS Tularemia Detection Kit (the algorithm/assay) when used with the new Platinum Path sample purification kit. The "JBAIDS operators were blinded to the analyte content of the samples," indicating a focus on the assay's performance independent of operator knowledge of the expected outcome. The device's software provides the final interpretation (positive, negative, uncertain, or inhibited).
Type of Ground Truth Used:
- Surrogate Clinical Specimens: Ground truth was established by spiking known concentrations of inactivated F. tularensis into prospectively collected or residual human specimens. For comparative purposes, the results from the predicate device's purification method were also used as a reference for "correctness."
- Limit of Detection (LoD): Ground truth was based on the known, spiked concentrations of F. tularensis.
- Reproducibility: Ground truth was based on the known, spiked concentrations (medium positive, low positive) or unspiked status (negative).
- Direct Culture Samples: Ground truth was based on the known identity of the colonies (F. tularensis or non-F. tularensis).
Sample Size for Training Set:
The document does not specify a separate "training set" sample size. As this is a modification to an existing, cleared diagnostic kit (K072547), the current study focuses on validation of the modification (addition of a new sample purification kit). The development and initial validation of the JBAIDS Tularemia Detection Kit itself would have involved training data, but that information is not part of this 510(k) summary for the modification.
How Ground Truth for Training Set Was Established:
Since no training set details are provided in this document, the method for establishing ground truth for any potential training set for the original device is not described here. Typically, for IVD assays, training data would involve well-characterized samples (e.g., clinical samples confirmed by culture or other gold-standard methods, or contrived samples with known analyte concentrations).

Summary

{0}------------------------------------------------

JUL 3 1 2013

10 510(k) Summary

510(k) Summary BioFire Diagnostics, Inc.

Modification of the JBAIDS Tularemia Detection Kit for use with the IT 1-2-37M 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 25, 2013

Device Name and Classification:

Trade Name: JBAIDS Tularemia Detection Kit Regulation Number: 21 CFR 866.3280

Classification Name: Reagent Kit: F. tularensis, Class II

Product Code: OEH

Predicate Device:

JBAIDS Tularemia Detection Kit (K072547)

Intended Use:

{1}------------------------------------------------

or sputum collected aseptically from individuals greater than 18 years of age suspected of having tularemia. In addition, positive blood cultures and colonies may be tested. This assay is intended to aid in the diagnosis of individual presenting with signs and symptoms of pneumonic or typhoidal tularemia. It is not intended to aid in the diagnosis of glandular, ulceroglandular, oculoglandular, or oropharyngeal tularemia.

Device Description:

{2}------------------------------------------------

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.

Substantial Equivalence:

The JBAIDS Tularemia Detection Kit is substantially equivalent to the previously cleared JBAIDS Tularemia Detection Kit. The following tables compare the modified JBAIDS Tularemia Detection Kit to the previously cleared JBAIDS Tularemia Detection Kit (K072547). The first table outlines the similarities between the two systems and the second table outlines the differences.

Element	New Device:JBAIDS Tularemia Detection Kitwith addition of Platinum PathSample Purification Kit	Predicate:JBAIDS Tularemia Detection Kit(K072547)
Intended Use	Presumptive identification of Tularemiainfection through the detection of aDNA sequence unique to Francisellatularensis. Results are used inconjunction with clinical information,culture, and other laboratory tests as anaid in the diagnosis individualspresenting with signs and symptoms ofpneumonic or typhoidal tularemia.	Same
Technology	Real-time PCR using hydrolysis probes	Same
OrganismDetected	Qualitative in vitro detection ofFrancisella tularensis DNA	Same
SpecimenTypes	Whole blood (collected in 3.2% sodiumcitrate), sputum collected asepticallyfrom individuals greater than 18 yearsof age suspected of having tularemia,blood culture (grown in soybean-caseindigest broth) or bacterial culture (grownon blood agar)	Same
Platform	JBAIDS Instrument	Same
Time Requiredfor Analysis ofSpecimen	Less than 3 hours	Same

Table 1. Similarities between the New Device and the Predicate

{3}------------------------------------------------

Element	New Device:JBAIDS Tularemia Detection Kitwith addition of Platinum PathSample Purification Kit	Predicate:JBAIDS Tularemia Detection Kit(K072547)
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).
	Sputum purified with IT 1-2-3TMPlatinum Path or IT 1-2-3TM VIBESample Purification Kits (or validatedequivalent).	Sputum purified with IT 1-2-3TM VIBESample Purification Kits (or validatedequivalent).
	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 Francisella tularensis (tularemia), are not available for testing due to the extreme rarity of natural infection with this organism. Therefore, two clinical evaluations using surrogate specimens were performed to validate the use of the IT 1-2-3TM Platinum Path Sample Purification Kit with the JBAIDS Tularemia Detection Kit.

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 F. tulurensis at concentrations near and above the system LoD, while the remaining 50 specimens were not spiked with F. tularensis. The level of inactivated F. tularensis used to spike these samples was relative to the LoD (1500 CFU/mL) established for Platinum Pathpurified whole blood specimens.

Once spiked, samples were then processed using both the new nucleic acid extraction method (Platinum Path) and the original nucleic acid extraction method (IT 1-2-37M QFLOWdana Sample Purification Kit; QFLOWdad) followed by testing with the JBAIDS Tularemia 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 specimen testing. The results obtained with the Platinum Path processed samples were compared to the results obtained with the

{4}------------------------------------------------

QFLOW 400 processed samples. The JBAIDS result for a sample purified using from the OFLOWana kit was considered the correct result. The final Tularemia interpretation for samples purified using the Platinum Path kit had a positive percent agreement (PPA) of 100% as compared to samples purified using the QFLOW(00 kit (50/50; 95% CI = 92.9-100%). The final JBAIDS Tularemia interpretation for samples purified using Platinum Path was negative for 50 out of 50 samples that were negative when purified using OFLOWdag. This represents a negative percent agreement (NPA) of 100% (50/50; 95% CI = 92.9-100%). Using samples spiked near the LoD for samples purified with the Platinum Path kit (1500 CFU/mL), the IT /-2-3 QFLOWd10 and Platinum Path Sample Purification Kits performed equivalently with respect to detection of F. tulgrensis in surrogate whole blood specimens tested with the JBAIDS Tularemia Detection Kit.

Table 3. JBAIDS Tularemia Detection Kit Performance on Spiked Whole Blood Samples Processed with the IT 1-2-3 Platinum Path and OFLOWda2 Sample Purification Kits

Positive Agreement				Negative Agreement
QFLOW +PlatinumPath +	QFLOW +PlatinumPath -	PPA	95% CIª	QFLOW -PlatinumPath -	QFLOW -PlatinumPath +	NPA	95% CIª
50	0	100%(50/50)	92.9-100%	50	0	100%(50/50)	92.9-100%

4 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.

Testing of Surrogate Sputum Clinical Specimens

One hundred (100) surrogate specimens were prepared using frozen residual sputum specimens. Fifty (50) of the specimens were spiked with inactivated F, tularensis at concentrations near and above the system LoD, while the remaining 50 specimens were not spiked with F. tularensis. Samples were then processed using both the new nucleic acid extraction method (Platinum Path) and the original nucleic acid extraction method (IT I-2-3TM VIBE Sample Purification Kit) followed by testing with the JBAIDS Tularemia Detection Kit. JBAIDS operators were blinded to the analyte content of the samples. Table 4 presents the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) for the surrogate sputum specimen testing. The results obtained with the Platinum Path processed samples were compared to the results obtained with the VIBE processed samples. The JBAIDS result for a sample purified using from the VIBE kit was considered the correct result. The final Tularemia result for samples purified using the Platinum Path kit had a positive percent agreement (PPA) of 100% as compared to samples purified using VIBE (49/49; 95% CI = 92.8-100%). The final JBAIDS Tularemia result for samples purified using Platinum Path was negative for 49 out of 51 samples that were negative when purified using VIBE. This represents a negative percent agreement (NPA) of 96.1% (49/51; 95% CI = 86.5-99.5%). The IT J-2-3 VIBE and Platinum Path Sample Purification Kits performed equivalently with respect to detection of F. tularensis in surrogate sputum specimens tested with the JBAIDS Tularemia Detection Kit.

{5}------------------------------------------------

Positive Agreement				Negative Agreement
VIBE +Plat Path+	VIBE +Plat Path-	PPA	95% CIª	VIBE -Plat Path-	VIBE -Plat Path+	NPA	95% CIª
49	0	100%(49/49)	92.8-100%	49	2b	96.1%(49/51)	86.5-99.5%

Table 4. JBAIDS Tularemia Detection Kit Performance on Spiked Sputum Samples Processed with the IT 1-2-3 Platinum Path and VIRE Sample Purification Kits

4 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.

False positive results obtained for one unspiked sample processed with Platinum Path, and for one sample spiked at the 1× LoD level (positive result after Platinum Path processing, but negative after VIBE processing). When a sample is spiked at the 1× LoD level, ≥95% of results are expected to be positive. Occasional negative results are therefore expected (approximately 1 out of 20), with the consequence in this case of a false positive comparative result for a sample spike at the 1× LoD level.

Selected Analytic Studies

Limit of Detection

The originally established LoD of 300 CFU/mL in whole blood purified using the IT I-2-3 OFLOW" Sample Purification Kit could not be confirmed using the Platinum Path Sample Purification Kit. Therefore, the system LoD for whole blood samples was increased by five-fold to 1500 CFU/mL. Twenty out of 20 independent whole blood specimens spiked with F. tularensis at the new LoD level and processed with the IT 1-2-3 Platinum Path Sample Purification Kit were detected with the JBAIDS Tularemia Detection Kit, establishing the new system LoD of 1500 CFU/mL F. tularensis in whole blood.

Nineteen (19) out of 20 independent sputum specimens spiked with F. tularensis at the LoD level and processed with the IT 1-2-3 Platinum Path Sample Purification Kit were detected with the JBAIDS Tularemia Detection Kit. This confirmed the LoD of 2000 CFU/mL in sputum that was originally established for sputum samples processed using the IT /-2-3 VIBE Sample Purification Kit.

SampleMatrix	Spiked F. tularensisConcentration(CFU/mL)	# Positive	%Positive	Tularemia TargetAssay Mean Cp+/- Std Dev
Whole Blood	1500a	20/20	100.0%	36.50 ± 1.81
Sputum	2000	19/20	95.0%	36.47 ± 1.70

Table 5. Confirmation of the F. tularensis LoDs for Platinum Path-Purified Whole Blood and Sputum Samples Tested with the JBAIDS Tularemia Detection Kit

4 The JBAIDS Tularemia LoD determined in Platinum Path-purified whole blood samples is five-fold greater (indicating decreased sensitivity) than the originally established JBAIDS Tularemia LoD determined in QFLOWana-purified whole blood samples.

{6}------------------------------------------------

Reproducibility

A multicenter study was performed to determine the overall system reproducibility when whole blood and sputum samples were processed with the IT /-2-3 Platinum Path Sample Purification Kit prior to testing with the JBAIDS Tularemia 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 F. tularensis at a medium positive (5× LoD) level, four samples spiked at a low positive level (1× LoD), and four samples that were not spiked. The level of inactivated F. tularensis used to spike these samples was relative to the system LoD (1500 CFU/mL) established for Platinum Path-purified whole blood specimens. Results for whole blood testing are summarized in Table 6. Samples spiked F. tularensis at the low positive (1× LoD) level yielded final positive results 86.5% of the time overall. Examination of Cp values indicates these samples were likely under-spiked to approximately the 0.5× LoD level, where detection is expected to be below 95%. Detection at this low positive level was reproducibly less than 100% across the sites, and the JBAIDS Tularemia Detection System is reproducible when used to test whole blood samples processed with the IT /-2-3 Platinum Path Sample Purification Kit.

Blood Spike Levela	Test Location	Number Positive	Number Uncertain	Number Negative	% Agreement with Expected Result	95% CI	Mean Cpb	Std Dev	%CV
Medium Positive (5× LoD)	Site 1	32/32	0/32	0/32	100%		35.16	0.77	2.19
	Site 2	32/32	0/32	0/32	100%		35.83	1.40	3.91
	Site 3	32/32	0/32	0/32	100%		33.88	1.34	3.96
	All Sites	96/96	0/96	0/96	100%	96.2-100	35.00	1.43	4.09
Low Positive (1× LoD)	Site 1	28/32	0/32	4/32	87.5%		38.47	2.31	6.00
	Site 2	24/32	5/32	3/32	75%		39.38	2.32	5.89
	Site 3	318/32	0/32	1/32	96.9%		36.53	2.32	6.35
	All Sites	83/96	5/96	8/96	86.5%h	78.0-92.6	38.13	2.59	6.79
Negative	Site 1	0/32	0/32	32/32	100%
	Site 2	0/32	0/32	32/32	100%
	Site 3	0/32	0/32	32/32	100%
	All Sites	0/96	0/96	96/96	100%	96.2-100

Table 6. Reproducibility of the Tularemia Target Assay in the JBAIDS Tularemia Detection Kit for Whole Blood Samples Purified with the IT 1-2-3 Platinum Path Purification Kit

4 The level of inactivated F. ularensis used to spike these samples was relative to the reset system LoD (1500 CFU/mL) established for Platinum Path-purified whole blood specimens.

0 Co values included for the samples that amplified only.

& Three results were initially uncertain but were positive when retested.

d Two results were initially uncertain but were negative when retested.

e Eight results were initially uncertain but were positive when retested.

f Five results were initially uncertain and were uncertain when retested.

{7}------------------------------------------------

8Three results were initially uncertain but were positive when retested.

4 Samples spiked at the low positive level (1× LoD) yielded final positive results 86.5% of the time overall, with retesting required for initial uncertain results reproducibly observed at all three sites. Examination of Cp values indicates these samples were likely under-spiked to approximately the 0.5× LoD level, where detection is expected to be below 95%.

A panel of 9 sputum samples was similarly tested twice each day for five days at each of three testing sites. This panel contained three samples spiked with inactivated F. tularensis at a medium positive (5×LoD) level, three samples spiked at a low positive level (1×LoD), and three samples that were not spiked. Results for sputum testing are summarized in Table 7. The detection rate was ≥97.8% for all sputum samples containing F. tularensis spiked near or above the LoD, and there were no false positive results for unspiked samples. The JBAIDS Tularemia Detection System is reproducible when used to test sputum samples processed with the IT 7-2-3 Platinum Path Sample Purification Kit.

Table 7. Reproducibility of the Tularenia Target Assay in the JBAIDS Tularemia Detection Kit for Sputum Samples Purified with the IT 1-2-3 Platinum Path Purification Kit

Sputum Spike Level	Test Location	Number Positive	Number Uncertain	Number Negative	% Agreement withExpected Result	95% CI	Mean Cpa	Std Dev	%CV
Medium Positive (5× LoD)	Site 1	30/30	0/30	0/30	100%		35.35	1.46	4.13
	Site 2	30/30	0/30	0/30	100%		34.65	0.66	1.90
	Site 3	30/30	0/30	0/30	100%		34.37	0.53	1.54
	All Sites	90/90	0/90	0/90	100%	96.0-100	34.79	1.05	3.02
Low Positive (1× LoD)	Site 1	28b/30	1c/30	1/30	93.3%		39.19	2.62	6.69
	Site 2	30d/30	0/30	0/30	100%		38.49	2.37	6.16
	Site 3	30e/30	0/30	0/30	100%		38.15	2.22	5.82
	All Sites	88/90	1/90	1/90	97.8%	92.2-99.7	38.60	2.43	6.30
Negative	Site 1	0/30	0/30	30/30	100%
	Site 2	0/30	0/30	30/30	100%
	Site 3	0/30	0/30	30/30	100%
	All Sites	0/90	0/90	90/90	100%	96.0-100

4 Cp values included for the samples that amplified only.

Four results were initially uncertain but were positive when retested.

C One result was initially uncertain and was uncertain when retested.

d Two results were initially uncertain but were positive when retested.

& One result was initially uncertain and was positive when retested.

Detection of Direct Culture Samples Processed with the IT 1-2-3 Platinum Path Sample Purification Kit

F. tularensis colonies can be detected using a Platinum Path protocol to process the colonies followed by testing with the JBAIDS Tularemia Detection Kit. Ten F. tularensis

{8}------------------------------------------------

colonies were purified alongside ten non- F. tularensis colonies. All ten F. tularensis colonies were detected with the JBAIDS Tularemia Detection Kit, while the non- F. tularensis colonies were not detected.

Colony Type	Tularemia Target
	Positive Results/Total	Cp (cycles)
		Mean	SD
F. tularensis	10/10	21.00	0.31
Non- F. tularensis	0/10	-	-

Table 8. Tularemia Target Detection from Colonies Purified with Platinum Path

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

CYNTHIA PHILLIPS, Ph.D. MANAGER, JBAIDS REGULATED PRODUCTS BIOFIRE DIAGNOSTICS, INC. 390 WAKARA WAY SALT LAKE CITY UT 84108

July 31, 2013

Re: K131936

Trade/Device Name: JBAIDS Tularemia Detection Kit Regulation Number: 21 CFR 866.3280 Regulation Name: Francisella tularensis Serological Reagents Regulatory Class: II Product Code: OEH Dated: June 25, 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 misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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.

{10}------------------------------------------------

Page 2-Ms. 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.lda.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 -S 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

{11}------------------------------------------------

Indications for Use

510(k) Number (if known): K131936 Device Name: JBAIDS Tularemia Detection System

The JBAIDS Tularemia Detection Kit is run on the JBAIDS instrument using the Diagnostic Wizard. Results are for the presumptive identification of F. tularensis in conjunction with culture and other laboratory tests. The definitive identification of F, tularensis from colony growth, liquid blood culture growth, blood specimens, or sputum specimens requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required.

The JBAIDS Tularemia Detection Kit is intended for use by trained clinical laboratory personnel who have received specific training on the use of the JBAIDS Tularemia Detection Kit. The level of F. tularensis that would be present in blood or sputum from individuals with early systemic or pneumonic infection is unknown. Due to the difficulty in obtaining clinical specimens. this assay was not evaluated with blood or sputum from individuals presenting with signs and symptoms of tularemia who have subsequently developed pneumonic or typhoidal tularemia pneumonic or typhoidal tularemia.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE

Page 1 of 2

{12}------------------------------------------------

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Image /page/12/Picture/2 description: The image shows the text "John Hobson -S" at the top. Below that is "2013:07:31" and "08:51:00-04'00'". There is a logo in the background that is difficult to make out.

Regulation Number and Section

§ 866.3280

Francisella tularensis serological reagents.(a)
Identification. Francisella tularensis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toFrancisella tularensis in serum or to identifyFrancisella tularensis in cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyFrancisella tularensis directly from clinical specimens. The identification aids in the diagnosis of tularemia caused byFrancisella tularensis and provides epidemiological information on this disease. Tularemia is a desease principally of rodents, but may be transmitted to humans through handling of infected animals, animal products, or by the bites of fleas and ticks. The disease takes on several forms depending upon the site of infection, such as skin lesions, lymph node enlargements, or pulmonary infection.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.