JBAIDS Q FEVER DETECTION KIT

K103207 · Idaho Technology, Inc. · OVF · May 20, 2011 · Microbiology

Device Facts

• Record ID: K103207
• Device Name: JBAIDS Q FEVER DETECTION KIT
• Applicant: Idaho Technology, Inc.
• Product Code: OVF · Microbiology
• Decision Date: May 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3500
• Device Class: Class 1

Intended Use

The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Q Fever Detection Kit is a qualitative real-time polymerase chain reaction (PCR) test kit intended to identify and detect target DNA sequence from Coxiella burnetii in serum collected from individuals suspected of having acute Q fever, typically 7-10 days after onset of symptoms or before antibody formation. This in vitro diagnostic (IVD) test is intended to aid in the diagnosis of Q fever in individuals presenting with signs and symptoms of acute Q fever when used in conjunction with other clinical and laboratory findings. This kit is only intended to aid in the diagnosis of Q fever of patients presenting in the acute stage of the disease. Negative results do not preclude C. burnetii infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. The JBAIDS Q Fever assay is run on the JBAIDS instrument using the Diagnostic Wizard. Results are for the presumptive identification of C. burnetii in conjunction with serology and/or other laboratory tests. The following considerations also apply: - The diagnosis of acute Q fever must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence, in addition to the identification of C. burnetii from serum specimens. - Sensitivity is decreased by ~25-40%, with no change in specificity, if the sample is collected after the patient has formed specific antibodies to C. burnetii, typically 7-10 days after onset of symptoms. - The definitive identification of C. burnetii from serum specimens requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required. The test performance characteristics for this system were established with banked, frozen serum specimens that were sequentially received during a specified time period. The safety and effectiveness of other types of tests or sample types have not been established. All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by JBAIDS instructors or designees prior to use. Use of this device is limited to designated Department of Defense (DoD) laboratories equipped with the JBAIDS instruments.

Device Story

JBAIDS Q Fever Detection Kit uses real-time PCR to detect C. burnetii IS1111 DNA in human serum. Input: purified serum samples; processed via JBAIDS instrument using freeze-dried reagents in glass capillaries. Operation: multiplexed PCR with hydrolysis probes; target detected at 530 nm, internal inhibition control at 705 nm. Output: qualitative result (positive/negative/inhibited/uncertain/invalid) generated by JBAIDS software. Used in DoD laboratories by trained personnel. Software automates thermal cycling, fluorescence monitoring, and curve analysis. Results aid clinicians in diagnosing acute Q fever; negative results do not rule out infection. Benefits include rapid identification of C. burnetii during the acute phase before antibody formation, facilitating timely clinical management.

Clinical Evidence

Clinical study evaluated 465 subjects using banked, frozen serum. Sensitivity ranged from 29-81% depending on site and purification method; specificity was 100% for serology-negative samples. Performance is significantly higher in patients prior to seroconversion (62.9% positive rate) compared to those with established antibodies. Bench testing confirmed 100% LoD detection (10 TCID50/mL) and 100% exclusivity against 22 non-C. burnetii strains.

Technological Characteristics

Real-time PCR system using hydrolysis probes. Components: JBAIDS instrument (portable thermocycler/fluorimeter), freeze-dried reagent vials (Positive/Negative/Unknown controls), and DNA extraction kits. Connectivity: JBAIDS instrument with laptop. Software: Diagnostic Wizard for automated interpretation. Operates on heating/cooling cycles via heating coil and fan speed control. Fluorescence monitored at 530 nm (target) and 705 nm (inhibition control).

Indications for Use

Indicated for qualitative detection of Coxiella burnetii DNA in serum from patients suspected of acute Q fever, typically 7-10 days post-symptom onset or pre-antibody formation. Used as an aid in diagnosis in conjunction with clinical/laboratory findings. Limited to designated DoD laboratories.

Regulatory Classification

Identification

Rickettsia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rickettsia in serum. Additionally, some of these reagents consist of rickettsial antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify rickettsia directly from clinical specimens. The identification aids in the diagnosis of diseases caused by virus-like bacteria belonging to the genus Rickettsiae and provides epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).

Predicate Devices

• Focus Diagnostics Q Fever IgM IFA (K913906)
• Focus Diagnostics Q Fever IgG IFA (K922374)

Submission Summary (Full Text)

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K103207

いつきのですが、そのためになるところです。 ときになると、いつきはあり、ありましていたい

MAY 2 0 2011

#### 510(k) Summary 1 19949

# 510(k) Summary Idaho Technology Inc. JBAIDS Q Fever Detection Kit

| | Introduction: According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted<br>by: | Idaho Technology Inc.<br>390 Wakara Way<br>Salt Lake City, UT 84108<br><br>Telephone: [phone]<br>Facsimile: 801-588-0507<br><br>Contact Person: Beth Lingenfelter, ext. 407<br><br>Date Prepared: Oct. 29, 2010 |
| Device<br>Name: | Trade Name:<br>JBAIDS Q Fever Detection Kit<br><br>Common Name:<br>Real-time PCR amplification and detection system for targeted Coxiella<br>burnetii DNA sequences |

Classification Name:

Reagent Kit: Rickettsia serological reagents (CFR 866.3500)

:
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#### The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Q Device Description: Fever Detection Kit is a fully integrated in-vitro diagnostic (IVD) system · composed of the JBAIDS instrument with laptop computer, software, a freezedried reagent assay for the qualitative detection of pathogenic Coxiella burnetii, and 2 different sample preparation protocols for isolating target DNA from serum. Use of the JBAIDS DNA Extraction Control kit (not included) is also recommended.

The JBAIDS instrument, using Polymerase Chain Reaction (PCR) technology, is a portable thermocycler and real-time fluorimeter. The JBAIDS Q Fever Detection Kit is specially designed for PCR in glass capillaries using the JBAIDS instrument and hydrolysis probes for sequence-specific detection of the C. burnetii IS1111 DNA target.

The reagent kit contains 3 different types of freeze-dried reagent vials: Positive Controls, Negative Controls, and Unknowns (used for testing the patient sample). Each JBAIDS assay requires a Positive and Negative Control, and each sample is tested using an Unknown reagent vial which contains a multiplexed target and inhibition control (IC) assay.

Prior to testing, serum samples are purified using the Idaho Technology IT 1-2-3™ QFLOW or IT 1-2-3™ Platinum Path Sample Purification Kit. The resulting purified sample is added to an Unknown reagent vial, along with reconstitution buffer. A Positive Control and a Negative Control vial are prepared using reconstitution buffer and reagent grade water. Aliquots from each reagent vial are transferred to 2 reaction capillaries that are tested together in the JBAIDS instrument. The instrument is programmed to perform heating and cooling cycles that drive the PCR process. The heating and cooling cycles are generated using a heating coil and varying fan speeds. Fluorescence emission is monitored over 1 of 3 wavelengths, and the instrument software interprets the change in fluorescence to determine whether the target DNA is present.

When the organism is present, a fragment of C. burnetii DNA is amplified using specific primers. The amplicon is detected by fluorescence using a specific hydrolysis probe. The hydrolysis probe contains a short oligonucleotide that hybridizes to an internal sequence of the amplified fragment during the annealing phase of the PCR cycle. This probe has the 5' and 3' ends labeled with a reporter dye and a quenching dye, respectively. When the probe hybridizes to the specific DNA target, the Taq polymerase enzyme replicating the targetspecific DNA hydrolyzes the probe, which separates the two fluorophores, thus allowing the reporter dye to fluoresce. Fluorescence is monitored at a wavelength of 530 nm. Inhibition is monitored using an internal inhibition control. The inhibition control consists of a linearized plasmid containing an artificial intervening sequence flanked by target assay primer sequences. Similar to the target, the IC probe also has the 5' and 3' ends labeled with a reported and quenching dye, respectively. Hydrolysis of the IC probe during amplification is monitored at a wavelength of 705 nm.

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The level of fluorescence from each unknown sample and control is measured by the JBAIDS instrument. JBAIDS Software analyzes fluorescence amplification curves and reports results as Positive, Negative, Inhibited, or Uncertain. A failure of the Positive or Negative Control will result in the entire run being called Inyalid. Failure of the Inhibition Control when no target amplification is observed yields an Inhibited result for the associated sample and requires retesting of that sample. A positive result for the target will override an inhibited result.

The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Q Intended Use: Fever Detection Kit is a qualitative real-time polymerase chain reaction (PCR) test kit intended to identify and detect target DNA sequence from Coxiella burnetii in serum collected from individuals suspected of having acute Q fever, typically 7-10 days after onset of symptoms or before antibody formation. This in vitro diagnostic (IVD) test is intended to aid in the diagnosis of Q fever in individuals presenting with signs and symptoms of acute Q fever when used in conjunction with other clinical and laboratory findings. This kit is only intended to aid in the diagnosis of Q fever of patients presenting in the acute stage of the disease. Negative results do not preclude C. burnetii infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.

> The JBAIDS O Fever assay is run on the JBAIDS instrument using the Diagnostic Wizard. Results are for the presumptive identification of C. burnetii in conjunction with serology and/or other laboratory tests. The following considerations also apply:

- The diagnosis of acute O fever must be made based on history, signs, . symptoms, exposure likelihood, and other laboratory evidence, in addition to the identification of C. burnetii from serum specimens.
- Sensitivity is decreased by ~25-40%, with no change in specificity, if . the sample is collected after the patient has formed specific antibodies to C. burnetii, typically 7-10 days after onset of symptoms.
- The definitive identification of C. burnetii from serum specimens . requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required.

The test performance characteristics for this system were established with banked, frozen serum specimens that were sequentially received during a specified time period. The safety and effectiveness of other types of tests or sample types have not been established.

All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by JBAIDS instructors or designees prior to use. Use of this device is limited to designated Department of Defense (DoD) laboratories equipped with the JBAIDS instruments.

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| Substantial<br>Equivalence: | The JBAIDS Q Fever Detection System is substantially equivalent to other<br>products in commercial distribution intended for similar use. The JBAIDS<br>instrument has been previously cleared under K051713. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

The predicate for the JBAIDS Q Fever Detection Kit is the Focus Diagnostics IgM and IgG IFA tests cleared under K922374 and K913906. The following table compares the JBAIDS Q Fever Detection System with the predicate test.

| | | Table 1. Similarities and Differences between the JBAIDS Q Fever Detection Kit and the Focus Diagnostics |
|-----------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| IFA tests | | |
| | Company of Children Children Children Children Children Children | |

| ELEMENT | JBAIDS Q Fever Detection Kit | Focus Diagnostics Q Fever IgG and IgM tests |
|----------------------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Qualitative detection of C. burnetii | Detection and semi-quantitation of the human<br>IgG and IgM antibody response to phase I<br>and phase II<br>Coxiella burnetii antigens and as an aid in the<br>diagnosis of Q fever. |
| Indications for Use | Identification of C. burnetii in individuals<br>suspected of having Acute Q Fever. | Serodiagnosis of both acute and chronic C.<br>burnetii infections. |
| Technological<br>Principles | Real-time PCR using hydrolysis probes. | Microscopic visualization of human<br>antibodies for C. burnetii bacteria via a two<br>stage "sandwich" procedure using a<br>fluorescently labeled antibody that binds to<br>the human antibodies. |
| Assay Target | IS1111 DNA sequences unique to C. burnetii. | Human antibody response to C. burnetii. |
| Specimen Types | Serum | Same |
| Instrumentation | JBAIDS instrument (K051713) | Fluorescent microscope |
| Time Required for<br>Analysis of<br>Specimen | Less than 3 hours | Same |
| Sample Preparation<br>Method | Up front sample processing is required to<br>extract nucleic acid. | Diluted samples are tested directly. |
| Sample Controls | Internal control is multi-plexed with the target<br>test. | No sample specific control. |
| Testing strategy | One time point testing during the symptomatic<br>phase of the disease. | Two serology time points are suggested. One<br>during the symptomatic phase of the disease<br>with follow-up testing 2-3 weeks later. |
| Optimal Window of<br>Detection | Early in the disease course prior to antibody<br>formation. | Later in the disease course due to the time<br>required for antibody formation. |
| Test Interpretation | Automated test interpretation and report<br>generation. | Subjective interpretation by user. |
| Physical Properties | Freeze dried reagents with reconstitution<br>buffer and water provided in kit. | Liquid reagents. IgM and IgG are separate<br>test kits. |
| Storage | Room temperature (18-28°C) | Refrigerator temperature (2-8°C) |

The JBAIDS Q Fever Detection System is intended for the qualitative IVD detection of target DNA sequence from the C. burnetii pathogen. The system can be used to test human serum. The results from the PCR tests are used in conjunction with serology and

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other laboratory tests and clinical information as an aid in the diagnosis of systemic Q Fever infection in individuals suspected of having the disease.

The predicate device and the JBAIDS system have a similar intended use; they both provide test results that aid in the diagnosis of O Fever when considered with other clinical and laboratory evidence.

## Performance Data

## LoD

The JBAIDS Q Fever Detection System vielded positive results 20/20 (100%) with the JBAIDS Q Fever assay for serum samples spiked with the limit of detection level (10 TCID50 mL) of live C. burnetii for both the IT 1-2-37M Platinum Path and IT 1-2-3TM QFLOWand purification kits. In addition 10/10 (100%) of the isolates (see Table 2) included in the C. burnetii inclusivity panel were correctly identified by the JBAIDS assay the determined system LoD.

| Strain ID | Group |
|-------------------------|-------|
| Nine Mile Phase I | I |
| QiYi | I |
| RSA334 | I |
| Henzerling Phase I Salk | II |
| M44 – Grita | II |
| Idaho Q | III |
| Q173-P | IV |
| Q154-kAV | IV |
| WAV | V |
| Q229 | V |

# Exclusivity

The analytic specificity evaluation of the JBAIDS Q Fever Detection System was conducted with organisms that are phylogenetically related to C. burnetii, as well as with unrelated organisms that are likely to be found in clinical samples.

The JBAIDS Q Fever Detection System assays also proved to be very specific.

- . 22 of 22 non-C. burnetii strains (see Table 3) tested in the exclusivity panel were negative when tested at high concentration.
- . 2 of 2 phylogenetically related genera. Ehrlichia and Neorickettsia, were evaluated in silico. This evaluation indicated that the primers and probes in the JBAIDS Q Fever assay would not cross-react with organisms from these genera.

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| Organism | Relevance | Conc. Tested CFU/mL |
|---------------------------------------|-----------------------------------------------------------------|---------------------|
| Legionella pneumophila | Nearest Neighbor | $10^6$ |
| Legionella longbeacheae | Nearest Neighbor | $10^6$ |
| Legionella micdadei | Nearest Neighbor/Cross reactive with serology | $10^6$ |
| Bartonella henselae | Cross reactive with serology | $10^6$ |
| Rickettsia prowazekii | Other small obligate intracellular bacteria, agents of zoonoses | $10^6$ |
| Mycobacterium tuberculosis | Similar symptoms | $10^6$ |
| Brucella meliteusis | Similar symptoms | 4.2 x $10^4$ |
| Orientia tsutsugamushi | Similar symptoms | $10^6$ |
| Francisella tularensis | Similar symptoms | 4.5 x $10^5$ |
| Salmonella enteric | Similar symptoms | $10^6$ |
| Listeria monocytogenes | Similar symptoms | $10^6$ |
| Haemophilus influenzae | Similar symptoms | $10^6$ |
| Streptococcus pyogenes | Commonly encountered | $10^6$ |
| Aggregatibacter actinomycetemcomitans | Commonly encountered | $10^6$ |
| Haemophilus parainfluenzae | Commonly encountered | 7.8 x $10^4$ |
| Acinetobacter baumannii | Commonly encountered | $10^6$ |
| Vibrio cincinnatiensis | Commonly encountered | $10^6$ |
| Escherichia coli | Commonly encountered | $10^6$ |
| Staphylococcus aureus | Commonly encountered | $10^6$ |
| Staphylococcus epidermidis | Commonly encountered | $10^6$ |
| Pseudomonas aeruginosa | Commonly encountered | $10^6$ |
| Serratia marcescens | Commonly encountered | $10^6$ |

.

### Table 3, Exclusivity Panel

ldaho Technology Inc. 510(k) JBAIDS Q Fever Detection Kit

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#### Reproducibility

A multicenter reproducibility study was conducted in which a panel of specimens was tested twice a day for five days at two test sites and for seven days at a third test site. Results are summarized in Tables 4 and 5, and demonstrate the JBAIDS Q Fever Detection kit provides highly reproducible test results when testing at or above the established system LoD.

| | Table 4. Reproducibility Study Summary (Agreement with Expected Positive Results) for the JBAIDS Q Fever | |
|---------------|----------------------------------------------------------------------------------------------------------|--|
| Detection Kit | | |

| Test Level | | | IT 1-2-3 Platinum Path Sample<br>Purification Kit | | | | IT 1-2-3 QFLOWdna Sample<br>Purification Kit | | | | Both<br>Purification<br>Kits, All<br>Sites | 95% CI |
|-------------------------|---------------|---------------|---------------------------------------------------|-----------------|---------------|---------------|----------------------------------------------|-----------------|-----------------|------------|--------------------------------------------|--------|
| | Site 1 | Site 2 | Site 3 | All Sites | Site 1 | Site 2 | Site 3 | All Sites | | | | |
| 5X LoD | 21/21 | 15/15 | 15/15 | 51/51<br>100% | 21/21 | 15/15 | 15/15 | 51/51<br>100% | 102/102<br>100% | 96.5-100.0 | | |
| LoD | 21/21 | 15/15 | 15/15 | 51/51<br>100% | 21/21 | 15/15 | 15/15 | 51/51<br>100% | 102/102<br>100% | 96.5-100.0 | | |
| LoD/15 | 11/21 | 8/15 | 13/15 | 32/51<br>63% | 7/21 | 8/15 | 6/15 | 21/51<br>41% | 53/102<br>52% | 41.8-62.0 | | |
| Detection ≥<br>LoD | 42/42<br>100% | 30/30<br>100% | 30/30<br>100% | 102/102<br>100% | 42/42<br>100% | 30/30<br>100% | 30/30<br>100% | 102/102<br>100% | 204/204<br>100% | 98.2-100.0 | | |
| Detection all<br>Levels | 53/63<br>84% | 38/45<br>84% | 43/45<br>96% | 134/153<br>88% | 49/63<br>78% | 38/45<br>84% | 36/45<br>80% | 123/153<br>80% | 257/306<br>84% | 79.4 -87.9 | | |

Table 5. Reproducibility Study Summary (Average Cp and %CV) for the JBAIDS Q Fever Detection Kit

| Test<br>Level | IT 1-2-3 Platinum Path Sample Purification Kit | | | | | | | | IT 1-2-3 QFLOWdna Sample Purification Kit | | | | | | | |
|---------------|------------------------------------------------|---------|---------------|---------|---------------|---------|------------|---------|-------------------------------------------|---------|---------------|---------|---------------|---------|------------|---------|
| | Test Location | | Test Location | | Test Location | | All Sites | | Test Location | | Test Location | | Test Location | | All Sites | |
| | Ave.<br>Cp | %<br>CV | Ave.<br>Cp | %<br>CV | Ave.<br>Cp | %<br>CV | Ave.<br>Cp | %<br>CV | Ave.<br>Cp | %<br>CV | Ave.<br>Cp | %<br>CV | Ave.<br>Cp | %<br>CV | Ave.<br>Cp | %<br>CV |
| 5X<br>LoD | 30.94 | 2.5 | 30.81 | 2.4 | 30.30 | 1.3 | 30.71 | 2.3 | 31.53 | 1.2 | 31.25 | 1.3 | 31.53 | 1.3 | 31.45 | 1.3 |
| LoD | 32.73 | 2.0 | 32.54 | 1.8 | 32.42 | 2.5 | 32.58 | 2.1 | 33.35 | 1.6 | 33.18 | 1.4 | 33.53 | 1.1 | 33.35 | 1.4 |
| LoD/<br>15 | 35.27 | 1.2 | 35.14 | 3.2 | 34.94 | 2.1 | 35.11 | 2.3 | 35.36 | 2.3 | 35.33 | 3.1 | 35.33 | 1.6 | 35.34 | 2.4 |

Note: Only the results for positive capillaries are included.

### Clinical Studies

In addition to analytic studies, a multisite clinical trial was conducted.

The clinical performance of the JBAIDS Q Fever Detection Kit was performed using banked, frozen serum specimens that were sequentially received during a specified time period for which standard paired serological testing for Q fever had been previously performed. Three independent laboratories (located in distinct geographical regions; Australia, France and the Netherlands) were included in this

:

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study. Serum specimens from a total of 749 subjects were evaluated in the study, however 284 were excluded (86 for inconclusive or incomplete serology, 21 due to environmental contamination, 7 for inconclusive JBAIDS results and all 170 samples tested at site 3 due to deviations from the study protocol). Table 6 provides a summary of demographic information for the 465 subjects included in this study.

| Site | Site 1 | Site 2 | |
|----------------------------|----------------------|----------------------|-----|
| Number of Subjects | 303 | 162 | |
| Sex | Female (%) | 43% | 31% |
| | Male (%) | 57% | 69% |
| Age | Mean | 50 | 45 |
| | Min | 7 | 5 |
| | Max | 87 | 82 |
| Specimen Collection Period | 4/14/2008-10/15/2009 | 12/13/2005-6/26/2010 | |

Table 6. Demographic summary for JBAIDS Q Fever clinical study

Prior to testing with the JBAIDS Q Fever Detection Kit, serum samples were purified using either the IT 1-2-3 Platinum Path or the IT 1-2-3 QFLOWand sample purification kit. Out of the 465 specimens, 183 specimens had adequate volume to be purified using both purification methods. This resulted in a total of 324 final test results for Platinum Path (170 from serology positive specimens and 154 from serology negative specimens) and 324 final test results for QFLOW (171 from serology positive specimens and 153 from serology negative specimen).

Of the 307 tests of serology negative samples, 222 had no antibody to C. burnetti and 85 failed to show a 4-fold rise in antibody titer between the paired acute and convalescence samples. All but one serology negative sample, (306/307, 99.7%) gave the expected negative result when tested with the JBAIDS Q Fever Detection Kit. The one false positive was obtained from one of the samples that failed to show a fourfold rise in antibody titer.

Of the 252 tests on samples that were serology positive based upon a four-fold rise in antibodies, the JBAIDS Q Fever Detection system correctly identified the presence of C. burnetii in 17.8% (45/252) samples. However, the positive JBAIDS test result rate for those samples which exhibited seroconversion was significantly higher at 62.9% (56/89). These data are consistent with several published reports indicating that PCR detection of C. burnetii declines significantly once specific antibodies are detected by serology.

Clinical sensitivity ranged from 29-81% (variation between sites) on specimens collected prior to seroconversion. As shown in Table 7, the clinical sensitivity for the JBAIDS Q Fever Detection Kit was different at the two study sites. Site 1 had a

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lower detection rate (29% for specimens purified using the QFLOWd00 extraction kit and 47% for specimens purified using the Platinum Path purification kit) when compared to the detection rate at site 2 (81% for specimens purified using the QFLOWdna extraction kit and 77% for specimens purified using the Platinum Path purification kit). The differences observed at the two study sites may be the result of differences in organism strains, patient population or patient management. The clinical specificity was 100% at both sites for serology negative samples that had no antibody to C. burnetii.

Table 7. Sensitivity and Specificity for the JBAIDS Q Fever Detection Kit in Samples Tested for Acute Q Fever that were Seronegative

| Site | Purification Kit | TP/<br>(TP + FN) | Sensitivity<br>Percent | TN/<br>(TN + FP) | Specificity<br>Percent |
|------|------------------|------------------|------------------------|------------------|--------------------------|
| 1 | Platinum Path | 9/19 | 47%<br>(95% CI=24-71%) | 40/40 | 100%<br>(95% CI=91-100%) |
| 1 | QFLOWdna | 5/17 | 29%<br>(95% CI=10-56%) | 39/39 | 100%<br>(95% CI=91-100%) |
| 2 | Platinum Path | 20/26 | 77%<br>(95% CI=56-91%) | 71/71 | 100%<br>(95% CI=95-100%) |
| 2 | QFLOWdna | 22/27 | 81%<br>(95% CI=62-94%) | 72/72 | 100%<br>(95% CI=95-100%) |

Idaho Technology Inc. 510(k) JBAIDS Q Fever Detection Kit

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Image /page/9/Picture/1 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" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Idaho Technology, Inc. c/o Beth Lingenfelter Director of Regulated Products 390 Wakara Way Salt Lake City, Utah 84108

MAY 20 2011

Re: K103207

Trade/Device Name: JBAIDS Q Fever Detection Kit Regulation Number: 21 CFR 866.3500 Regulation Name: Rickettsia serological reagents Regulatory Class: Class I Product Code: OVF Dated: May 17, 2011 Received: May 18, 2011

Dear Ms. Lingenfelter:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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Page 2 - Beth Lingenfelter

notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Hay aAgus

Sally A. Hojvat, M.Sc. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Form

510(k) Number (if known): K103207 Device Name: JBAIDS O Fever Detection Kit

The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Q Fever Detection Kit is a qualitative real-time polymerase chain reaction (PCR) test kit intended to identify and detect target DNA sequence from Coxiella burnetii in serum collected from individuals suspected of having acute Q fever, typically 7-10 days after onset of symptoms or before antibody formation. This in vitro diagnostic (IVD) test is intended to aid in the diagnosis of O fever in individuals presenting with signs and symptoms of acute Q fever when used in conjunction with other clinical and laboratory findings. This kit is only intended to aid in the diagnosis of Q fever of patients presenting in the acute stage of the disease. Negative results do not preclude C. burnetii infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.

The JBAIDS Q Fever assay is run on the JBAIDS instrument using the Diagnostic Wizard. Results are for the presumptive identification of C. burnetii in conjunction with serology and/or other laboratory tests. The following considerations also apply:

- The diagnosis of acute Q fever must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence, in addition to the identification of C. burnetii from serum specimens.
- i Sensitivity is decreased by ~25-40%, with no change in specificity, if the sample is collected after the patient has formed specific antibodies to C. burnetii, typically 7-10 days after onset of symptoms.
- .. The definitive identification of C. burnetii from serum specimens requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required.

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 ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Ludolie K. Poole

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)_ R103267

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# Indications for Use Form

510(k) Number (if known): K103207 Device Name: JBAIDS Q Fever Detection Kit

The test performance characteristics for this system were established with banked, frozen serum specimens that were sequentially received during a specified time period. The safety and effectiveness of other types of tests or sample types have not been established.

All users, analysts, and any person reporting diagnostic results from use of this device should be trained to perform and interpret the results from this procedure by JBAIDS instructors or designees prior to use. Use of this device is limited to designated Department of Defense (DoD) laboratories equipped with the JBAIDS instruments.

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 ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Freddie L. Poole

:

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 183207 510(k)