MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM

K071188 · Idaho Technology, Inc. · NHT · May 21, 2007 · Microbiology

Device Facts

• Record ID: K071188
• Device Name: MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM
• Applicant: Idaho Technology, Inc.
• Product Code: NHT · Microbiology
• Decision Date: May 21, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3045
• Device Class: Class 2

Intended Use

The 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 human whole blood collected in sodium citrate from individuals suspected of having anthrax, positive blood cultures, and 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.

Device Story

JBAIDS is a portable, integrated IVD system for real-time PCR detection of B. anthracis. Inputs: whole blood, blood culture, or colony samples. Process: sample purification (IT 1-2-3 kits), followed by PCR amplification in glass capillaries using a thermocycler and fluorimeter. Hydrolysis probes detect specific DNA targets (pXO1/pXO2); Taq polymerase hydrolyzes probes upon hybridization, releasing reporter dye. Instrument monitors fluorescence across three wavelengths. Software analyzes amplification curves to report results as Positive, Negative, Inhibited, or Uncertain. Used in clinical laboratory settings by trained personnel. Output aids clinicians in presumptive diagnosis of systemic anthrax when combined with culture and clinical history. Benefits: rapid, automated molecular identification of pathogenic DNA sequences.

Clinical Evidence

Bench testing only. Method comparison study using 6 spiked citrated whole blood samples at LOD showed 100% agreement between new and predicate purification kits. Study of 16 healthy donor samples showed 100% negative results for both methods. Carry-over study (n=42) showed 2.4% carry-over rate for new kit, deemed equivalent to predicate performance.

Technological Characteristics

Real-time PCR system. Modification involves QIAamp spin column-based DNA purification. Reagents include protease K, carrier RNA, and Qiagen buffers (AL, AW1, AW2, AE). System includes JBAIDS instrument, laptop, and software. Operates via benchtop centrifuge for sample prep. Qualitative detection of pXO1/pXO2 plasmids.

Indications for Use

Indicated for qualitative in vitro diagnostic detection of B. anthracis DNA (pXO1 and pXO2 plasmids) in human whole blood (sodium citrate), positive blood cultures, and cultured organisms from blood agar plates in individuals suspected of having anthrax.

Regulatory Classification

Identification

An in vitro diagnostic device for Bacillus species (spp.) detection is a prescription device used to detect and differentiate among Bacillus spp. and presumptively identify B. anthracis and other Bacillus spp. from cultured isolates or clinical specimens as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp. This device may consist of Bacillus spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to presumptively identify bacillus-like organisms in clinical specimens; bacteriophage used for differentiating B. anthracis from other Bacillus spp. based on susceptibility to lysis by the phage; or antigens used to identify antibodies to B. anthracis (anti-toxin and anti-capsular) in serum. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused by B. anthracis, and gastrointestinal disease and non-gastrointestinal infections caused by B. cereus.

Special Controls

*Classification.* Class II (special controls). The special controls are set forth in FDA's special controls guideline document entitled “In Vitro Diagnostic Devices for*Bacillus* 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.

Predicate Devices

• Unmodified JBAIDS Anthrax Detection System (K051713)

Submission Summary (Full Text)

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K07//88

MAY 2 1 2007

#### 510(k) Summary 7 .. 1. remissioner portugues por esta programman por portugalites por de la colo lo concertain

## 510(k) Summary Idaho Technology Inc. JBAIDS Anthrax Detection System

| Introduction: | According to the requirements of 21 CFR 807.92, the following information provides<br>sufficient detail to understand the basis for a determination of substantial equivalence. |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | Idaho Technology Inc.<br>390 Wakara Way<br>Salt Lake City, UT 84108 |
| | Telephone: [phone]<br>Facsimile: 801-588-0507 |
| | Contact Person: Beth Lingenfelter, ext. 407 |
| | Date Prepared: April 27, 2007 |
| Device Name: | Trade Name:<br>JBAIDS Anthrax Detection System |
| | Common Name:<br>Real-time PCR amplification and detection system for targeted Bacillus anthracis<br>DNA sequences |
| | Classification Name:<br>System: Microorganism differentiation and identification device; 21 CFR 866.2660 |
| | Instrument: Micro Chemistry Analyzer for Clinical Use; 21 CFR 862.2170, product<br>code JJF |
| | Reagent Kit: (B. anthracis) NHT |

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Device The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Anthrax Detection System is a fully integrated in vitro chagnostic (IVD) system composed of the Description: following:

- D JBAIDS instrument with laptop computer
- . Software
- Two different freeze-dried reagent assays (in one kit) for the qualitative � detection of pathogenic Bacillus anthracis
- . Four different sample preparation protocols, two for isolating target DNA from whole blood, one for processing blood culture, and another for processing colonies.

The JBAIDS instrument, using Polymerase Chain Reaction (PCR) technology, is a portable thermocycler and real-time fluorimeter. The JBAIDS Anthrax Detection Kit is specially designed for PCR in glass capillaries using the JBAIDS instrument and hydrolysis probes for sequence-specific detection of B. anthracis DNA found on the pX01 plasmid (Target 1) and the pX02 plasmid (Target 2).

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

Before testing, whole-blood samples are purified using the Idaho Technology IT 1-2-3TM FLOW or QFLOWdir® Sample Purification Kit (or validated equivalent), while blood culture and direct culture specimens are prepared using the IT 1-2-3 SWIPE Sample Purification Kit (or validated equivalent). The resulting purified sample is added to an Unknown reagent vial and an Inhibition Control 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 two 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 one of three 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 B. anthracis 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 target-specific DNA, hydrolyzes the probe, which separates the two fluorophores, thus allowing the reporter dye to fluoresce.

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 "Invalid." Failure of the Inhibition Control vields an Inhibited result for the associated sample and requires retesting of that sample.

Idaho Technology Inc. Special 510(k) JBAIDS Anthrax Detection Kit

Confidential

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Intended Use: The JBAIDS Anthrax Detection System is intended for the qualitative IVD detection of targeted DNA sequences on the pX01 plasmid (Target 1) and the pX02 plasmid (Target 2) from the Bacillus anthracis pathogen. The system can be used to test human whole blood collected in sodium citrate, positive blood cultures, and cultured organisms grown on blood agar plates.

> The JBAIDS Anthrax Target 1 Assay, when run on the JBAIDS instrument, is a qualitative IVD test for the detection of one of two DNA sequence targets, both of which are essential for the organism's pathogenicity. The JBAIDS Anthrax Target 2 Assay, when run on the JBAIDS instrument, is a qualitative IVD test for the detection of the second DNA sequence target and is run as a confirmatory test after obtaining a Positive result from the Target 1 Assay. The results from these tests are used in conjunction with culture and other laboratory tests and clinical information as an aid in the diagnosis of systemic anthrax infection in individuals suspected of having the disease.

> These tests must be run on the JBAIDS instrument using the Diagnostic option for valid clinical results. Reports from the instrument are identified with the phrase "For In Vitro Diagnostic Use" when the Diagnostic option is used. Results that are not so identified should not be reported or used in patient diagnosis decisions.

Predicate The JBAIDS Anthrax Detection System is substantially equivalent to unmodified Device: system 510(k) number K0561713.

Table 1 Provides a comparison between the modified and unmodified device.

| ELEMENT | PREDICATE:<br>Unmodified JBAIDS Anthrax<br>Detection System (K051713) | New Device:<br>Modified JBAIDS Anthrax<br>Detection System |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Intended Use | Identification of anthrax infection<br>through the detection of 2 DNA<br>sequence targets, which are both<br>essential for Bacillus anthracis<br>pathogenicity. Results are used in<br>conjunction with clinical information,<br>culture, and other laboratory tests as<br>an aid in the diagnosis of systemic<br>anthrax infection in individuals<br>suspected of having the disease. | Same |
| Specimen | Whole blood (collected in 3.2%<br>sodium citrate), blood culture (grown<br>in soybean-casein digest broth), or<br>bacterial culture (grown on blood<br>agar) | Same |

| | | | | Table 1. Comparison of the modified and unmodified JBAIDS Anthrax Detection System. | |
|--|--|--|--|-------------------------------------------------------------------------------------|--|
|--|--|--|--|-------------------------------------------------------------------------------------|--|

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| ELEMENT | PREDICATE:<br>Unmodified JBAIDS Anthrax<br>Detection System (K051713) | New Device:<br>Modified JBAIDS Anthrax<br>Detection System |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specimen<br>Preparation | Purified with IT 1-2-3 FLOW Sample<br>Purification Kit or<br>IT 1-2-3 SWIPE Sample Purification<br>Kit (or validated equivalent) | Same, plus the addition of the IT 1-<br>2-3 QFLOWdna Sample Purification<br>Kit as an alternate method for the<br>purification of whole blood<br>samples. |
| Testing Platform | The JBAIDS instrument which is a<br>real-time PCR thermocycler. | Same |
| Time Required<br>for Analysis of<br>Specimen | Less than 3 hours | Same |
| Physical<br>Properties | Freeze dried reagents with<br>reconstitution water and buffer<br>provided in kit | Same |
| Test Result | Identification of two plasmids<br>required for pathogenicity of the<br>organism; both plasmids are found<br>together in virulent strains of B.<br>anthracis. | Same |

### Performance Summary:

A method comparison and carry-over study were performed and demonstrated that whole blood samples purified using the IT 1-2-3 QFLOWare Sample Purification Kit provide equivalent results as whole blood samples purified using the IT 1-2-3 FLOW Sample Purification Kit.

### Method Comparison:

Six (6) citrated whole blood samples spiked at the assay's limit of detection (LOD) with B. anthrocis were processed using the IT 1-2-3 QFLOWdia Sample Purification Kit and the II 1-2-3 FLOW Sample Purification Kit. All six samples processed using both methods were positive with the both the B. anthracis Target 1 and Target 2 assays. Samples purified using the IT 1-2-3 QFLOWdana protocol demonstrated equivalent, or better, recovery and purity of DNA.

Citrated whole blood samples from 16 normal healthy donors were processed using the IT 1-2-3 QFLOW400 and IT 1-2-3 FLOW Sample Purification Kits and then tested using both assays for Q LOW - and II - 2 - 2 - 2 - 1 - and 11 - 1 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 protocol gave negative test results for both assays. One sample processed using the IT 1-2-3 FLOW protocol gave an inhibited result with the Target 1 assay while the other 15 were negative. All 16 samples gave negative results with the Target 2 assay.

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#### Carrv-over:

To determine the rate of carry-over for the two sample purification kits, strongly positive samples (spiked at 5 x 10" CFUmL) were purified next to negative (unspiked) samples. The negative (spired at 9 x 10 °C L Crimi) white p Target 1 and Target 2 assays. For samples purified using the QFLOW™ protocol, carry-over was observed in 2.4% (1/42) of negative capillaries for the Target Q1 LOW - precodes, carry he Target 2 assay. The carry-over rate for the same samples processed r assay and 0% (0/12) for both the Target 1 and Target 1 and Target 2 assays. The rate of asing the 1 2011 protoce. the wo sample purification methods was determined to be equivalent and is also equivalent to the reported carry-over rate reported for blood culture samples purified using the IT 1-2-3 SWIPE Sample purification kit.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Beth Lingenfelter Regulatory Affairs Manager Idaho Technology Inc. 390 Wakara Way Salt Lake City, UT 84108

MAY 2 1 2007

Re: k071188

> Trade/Device Name: JBAIDS Anthrax Detection System Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism differentiation and identification device Regulatory Class: Class II Product Code: NHT Dated: April 27, 2007 Received: April 30, 2007

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 either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10gally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its tollsfree number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Sally, attorn

Sally A. Hojvat, M.Sc., Ph.D. 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

510(k) Number (if known): Device Name: JBAIDS Anthrax Detection System Indications for Use:

The 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 human whole blood collected in sodium citrate from individuals suspected of having anthrax, positive blood cultures, and 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:

- K 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.
- 트 The assays have not been evaluated with blood from individuals without clinical signs or symptoms who were presumed exposed and who subsequently developed anthrax (inhalation or other forms of the disease), or from individuals with any form of anthrax (inhalational, cutaneous, or gastrointestinal).
- The level of plasmid targets that would be present in blood from individuals with early systemic infection is unknown.
- . The definitive identification of B. anthracis from colony growth, liquid blood culture growth, or from blood specimens requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required.

The safety and effectiveness of other types of tests or sample types (not identified as "For in vitro diagnostic use") have not been established.

Prescription Use (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 Device Evaluation (ODE)

Freddie Lee Poole

ision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

ldaho Technology Inc. Special 510(k) JBAIDS Anthrax Detection System

510(k) Ko71188

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