JBAIDS ANTHRAC DETECTION SYSTEM

K051713 · Idaho Technology, Inc. · NHT · Nov 18, 2005 · Microbiology

Device Facts

• Record ID: K051713
• Device Name: JBAIDS ANTHRAC DETECTION SYSTEM
• Applicant: Idaho Technology, Inc.
• Product Code: NHT · Microbiology
• Decision Date: Nov 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3045
• Device Class: Class 2
• Attributes: Expedited Review

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, 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 Anthrax Detection System is an integrated IVD system for presumptive identification of B. anthracis; utilizes real-time PCR to detect pXO1 and pXO2 plasmid DNA sequences. Input: purified DNA from whole blood, blood cultures, or bacterial colonies. Process: DNA amplification in glass capillaries using hydrolysis probes (6-FAM/TAMRA); JBAIDS instrument (portable thermocycler/fluorimeter) performs PCR; software analyzes amplification curves via mathematical algorithms. Output: qualitative results (Positive, Negative, Inhibited, Uncertain, Invalid). Used in clinical/laboratory settings by trained personnel. Workflow: Target 1 tested first; Target 2 tested only if Target 1 is positive. Results provide presumptive identification; must be used with culture/clinical history. Benefits: rapid detection of virulence factors to aid clinical decision-making and public health response.

Clinical Evidence

Clinical evaluation included 150 symptomatic patients (mean age 48.5, 56% male) across three sites. Study compared JBAIDS results to standard culture/microbiology. No patients with B. anthracis bacteremia were identified. Clinical specificity was at least 98% (95% CI). Analytical studies included reproducibility (120/120 agreement for Target 1/2 in whole blood), limit of detection (1,000 CFU/mL), and analytical specificity against non-virulent B. anthracis and phylogenetically related organisms. Bench testing confirmed performance metrics.

Technological Characteristics

Portable thermocycler and fluorimeter; hot-air thermal cycling (30-99 °C); 32-position glass capillary format; 3-channel optical detection (530, 640, 710 nm). Uses freeze-dried reagent assays with hydrolysis probes. Ruggedized for military/field environments. Software-controlled via laptop.

Indications for Use

Indicated for qualitative detection of B. anthracis pXO1 and pXO2 plasmid DNA 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

• LightCycler Instrument Version 1.2 (K033734)
• Microbiological Identification (Preamendment Device)

Submission Summary (Full Text)

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K051713

## 510(k) Summary 1

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

| 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: | 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: | November 14, 2005 |
| Device Name: | Trade Name:<br>JBAIDS Anthrax Detection System |
| | Common Name:<br>Real-time PCR amplification and detection system for targeted Bacillus anthracis 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 code JJF

Reagent Kit: (B. anthracis) Unclassified

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#### The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Device Anthrax Detection System is a fully integrated in-vitro diagnostic (IVD) system Description: composed of the JBAIDS instrument with laptop computer, software, 2 different freeze-dried reagent assays (in one kit) for the qualitative detection of pathogenic Bacillus anthracis, and 3 different sample preparation protocols for isolating target DNA from whole blood, blood culture, or direct culture.

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 detection of the pXO1 plasmid (Target 1) and the pXO2 plasmid (Target 2) DNA sequences. A fragment of plasmid DNA is amplified using specific primers, creating amplicon. The amplicon is detected using a specific hydrolysis probe, which is 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, separating the two fluorophores, thus allowing the reporter dye to fluoresce.

The reagent kit contains 4 different types of freeze-dried reagent vials: Positive Controls, Negative Controls, Inhibition Controls, and Unknowns (used for testing the patient sample). Each JBAIDS run requires a Positive and Negative Control, and each sample is tested using both an Inhibition Control vial and an Unknown reagent vial. The characteristics of the amplification curves from the positive control (PC), negative control (NC), inhibition controls (IC) and from each unknown sample are analyzed by the JBAIDS Software, and results are reported as Positive. Negative, Inhibited or Uncertain. When PCs or NCs are unacceptable, the test results for all samples in the JBAIDS run are considered invalid and must be repeated.

Prior to testing, whole-blood samples are purified using the Idaho Technology IT 1-2-37M FLOW Sample Purification Kit (or validated equivalent), while blood culture and direct culture specimens are prepared using the IT 1-2-31M 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.

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- 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:

- 트 The diagnosis of anthrax infection must be made based on history, signs, symptoms, exposure likelihood, other laboratory evidence, in addition to the identification of pXO1 and pXO2 targets either from cultures or from direct blood specimens.
- D The assays have not been evaluated with blood from individuals without clinical signs or symptoms who were presumed exposed and who subsequently developed anthrax (inhalation or other forms of the disease), or from individuals with any form of anthrax (inhalational, cutaneous, or gastrointestinal).
- . The level of plasmid targets that would be present in blood from individuals with early systemic infection is unknown.
- The definitive identification of B. anthracis from colony growth, liquid blood culture growth, or from blood specimens requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required.

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

The JBAIDS Anthrax Detection System is substantially equivalent to other Substantial Equivalence: products in commercial distribution intended for similar use. The JBAIDS instrument is substantially equivalent to the currently marketed LightCycler® Instrument Version 1.2, cleared under K033734.

> The predicate for the JBAIDS Anthrax Detection Kit is traditional microbiological identification of the organism (preamendment methods) with confirmation by the Centers for Disease Control Laboratory Response Network Gamma Phage Lysis assay.

The following tables compare the JBAIDS Anthrax Detection System with the predicate devices, the LightCycler and classical microbiology.

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# Table1. JBAIDS Instrument System vs. LightCycler®

| ELEMENT | NEW PRODUCT:<br>JBAIDS Anthrax Detection System | PREDICATE:<br>LightCycler® (K033734) |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The JBAIDS instrument system is a<br>ruggedized automated real-time<br>PCR amplification and detection<br>system for nucleic acids using<br>fluorescence detection capable of<br>simultaneous and rapid<br>identification of multiple<br>microbiological agents from a<br>variety of biological specimens.<br>The JBAIDS is intended for use by<br>personnel trained in laboratory<br>techniques and on the use of the<br>analyzer.<br>For this application, the intended<br>use is for detection and<br>identification of B. anthracis in<br>whole blood, blood culture or direct<br>culture from patients suspected of<br>having anthrax. | The LightCycler® Instrument is a<br>fully automated amplification and<br>detection system for nucleic acids<br>using fluorescence detection. The<br>LightCycler® is intended to be used<br>by laboratory professionals trained<br>in laboratory techniques and on the<br>use of the Analyzer. |
| Primary<br>Operational<br>Components | Integrated thermocycler and<br>microvolume fluorimeter for walk-<br>away PCR amplification and<br>detection | Same |
| Detection<br>Procedure | Optical detection of stimulated<br>fluorescence | Same |
| Specimen Type | Purified nucleic acids | Same |
| Specimen<br>Preparation | Performed off-line | Same |
| Temperature<br>Range | 30-99 °C | 40-98 °C |
| User Interface | Ruggedized laptop with instrument-<br>specific software (JBAIDS version<br>2.1 or higher) | Laptop with instrument-specific<br>software (LightCycler® version 3.5<br>or higher) |
| Heating Method<br>Thermal Cycling | Hot-air cycling with glass capillaries | Same |
| Number of<br>Thermal Cyclers | One | Same |
| ELEMENT | NEW PRODUCT:<br>JBAIDS Anthrax Detection System | PREDICATE:<br>LightCycler® (K033734) |
| Capillary Positions | 32 | Same |
| Reaction Size | 5-20 µL in glass capillaries | 10-20 µL in glass capillaries |
| Number of Optical Detection Channels | Three with fixed wavelengths (530 nm, 640 nm, 710 nm) | Same |
| Detection Chemistry | Paired hybridization probes, hydrolysis probes (i.e. TaqMan™), double stranded DNA binding dyes. | Same |
| Detection Timing | Detection occurs at defined intervals during PCR cycle and can be viewed in real time. | Same |
| ELEMENT | NEW PRODUCT:<br>JBAIDS Anthrax Detection<br>System | PREDICATE:<br>Microbiological Identification<br>(Preamendment Device) |
| Intended Use | Qualitative in vitro diagnostic<br>(IVD) detection of target DNA<br>sequences on the pXO1<br>plasmid (Target 1) and the<br>pXO2 plasmid (Target 2) from<br>Bacillus anthracis. Results<br>are used in conjunction with<br>clinical information, culture,<br>and other laboratory tests as<br>an aid in the diagnosis of<br>anthrax infection in individuals<br>suspected of having the<br>disease. | Identification of anthrax infection through<br>clinical information and standard<br>microbiology techniques, including<br>morphologic characteristics, and confirmed<br>with CDC's Laboratory Response Network<br>(LRN) gamma phage lysis assay (CDC<br>catalog #BP3123)<br>Presumptive and confirmatory<br>identification is outlined in CDC<br>publication, Reference Laboratory General<br>Procedure for Identification of Bacillus<br>anthracis, "Table 2, B. anthracis<br>presumptive and confirmatory identification<br>criteria" (see Appendix F.3). |
| Specimen | Whole blood (collected in 3.2%<br>sodium citrate), blood culture<br>(grown in soybean-casein<br>digest broth), or bacterial<br>culture (grown on blood agar) | Whole blood or blood culture plated for<br>isolation of cells; sample is the growth<br>from isolated colony/pure culture. |
| Specimen<br>Preparation | Purified with IT 1-2-3™ FLOW<br>Sample Purification Kit or<br>IT 1-2-3™ SWIPE Sample<br>Purification Kit (or validated<br>equivalent) | Grown overnight on sheep blood agar<br>plate inoculated with gamma phage |
| Time Required<br>for Analysis of<br>Specimen | Less than 3 hours | 16-20 hours after obtaining isolated<br>colony; approximately 3 days after first<br>obtaining a patient sample |
| Physical<br>Properties | Freeze dried reagents with<br>reconstitution water and buffer<br>provided in kit | Stock suspension (phage) plus blood agar<br>plates |
| Test Result | Identification of 2 plasmids<br>required for pathogenicity of<br>the organism; both plasmids<br>are found together in virulent<br>strains of B. anthracis. | Identification of B. anthracis.<br>Pathogenicity of the organism is based on<br>patient symptoms and is not determined<br>by laboratory methods. |
| Storage and<br>Shelf Life | Six months at room<br>temperature (18-28 °C) | 2-8°C; phage viability decreases over time<br>and can be reduced or destroyed by<br>contaminants. |

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The JBAIDS instrument has technological characteristics nearly identical to those of the LightCycler, with the addition of ruggedization for the military environment. The JBAIDS instrument raises no new issues with respect to safety or effectiveness.

The predicate instrument (Roche LightCycler®) has been used by the Centers for Disease Control and Prevention (CDC) Laboratory Response Network for the detection of B. anthracis. The CDC reported high sensitivity and specificity for B. anthracis detection with the predicate device when used with a 5' nuclease probe.1 The LightCycler® has also been used to detect B. anthracis using HybProbe™ probes with high sensitivity and specificity.2

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# Table2. JBAIDS Anthrax Detection System vs. Microbiological Identification

Gamma phage is a specific bacterial virus used in the CDC Laboratory Response Network Gamma Phage Lysis Assay as an IVD culture plating method to distinguish B. anthracis from B. cereus and other Bacillus species. Lawns of suspected B. anthracis are inoculated with gamma phage. Clear or partially clear zones of bacterial lysis are indicative of B. anthracis. The result from this test is used in conjunction with culture

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

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 B. anthracis pathogen, both of which are essential for the organism's pathogenicity. The system can be used to test human whole blood collected in sodium citrate tubes, positive blood cultures, and cultured organisms grown on blood agar plates. The results from the PCR 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.

The preamendment predicate device and the JBAIDS system have the same intended use; they both provide test results that aid in the diagnosis of anthrax when considered with other clinical and microbiological evidence.

The JBADS Anthrax Detection System yielded positive results with both the Target 1 and Target 2 assays for 23/23 (100%) of the isolates included in the direct culture panel, and for 11/11 (100%) of the isolates included in the blood culture panel. For the direct culture and blood culture panels, all of the samples were confirmed as B. anthracis using standard biochemical identification and tested positive using the CDC Reference Laboratory Procedure for Identification of B. anthracis Using Lysis by Gamma Phage. In addition 67/68 (98.5%) whole blood samples spiked with limit of detection levels of live B. anthracis were correctly identified by the JBAIDS assay.

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

Regardless of the sample matrix, the JBAIDS Anthrax Detection System gave positive test results with both the Target 1 and Target 2 assays for all virulent strains of B. anthracis tested.

- 23 of 23 virulent strains of B. anthracis included in the direct culture panel were 트 detected by both assays.
- 11 of 11 virulent strains of B. anthracis included in the blood culture panel were 트 detected by both assays.

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

- . 34* of 37 non-B. anthracis strains tested in the direct culture panel were negative for both the Target 1 and Target 2 assays. This included 25 phylogenetically related organisms and 12 unrelated organisms that might be found in clinical samples.
- a 12 of 12 non-B. anthracis strains tested in the blood culture panel yielded negative results with both the Target 1 and Target 2 assays. This testing panel included 2 phylogenetically related organisms and 10 unrelated organisms that might be found in clinical samples.

*The assay did cross-react with 3 virulent forms of B. cereus; however, these specific isolates have been known to cause anthrax-like illnesses.3

In addition to analytic studies, a multi-site clinical trial was conducted. Due to the near absence of clinical samples from individuals with a diagnosis of systemic anthrax, the clinical trial was limited to an assessment of the system's clinical specificity. Blood samples from hospitalized subjects with clinical signs and symptoms consistent with

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inhalation or systemic anthrax and for whom a blood culture had been ordered, were tested for B. anthracis using the JBAIDS Anthrax Detection System and the results compared to the gold standard technique of blood culture. All 150 subject samples vielded negative test results using the JBAIDS Anthrax Detection system and B. yioloo iregan not identified in any of the blood cultures. The clinical specificity of the JBAIDS Anthrax Detection System is 100% (95% CI, 98%-100%).

Based on the available gamma phage literature and this study, the JBAIDS Anthrax Detection System appears to be as effective as the predicate assay. The JBAIDS software automatically interprets the assay results, reducing the opportunity for user error, and the freeze-dried assay format minimizes assay setup errors. An additional practical and safety advantage of the JBAIDS Anthrax Detection System over the predicate comes from the nature of the positive controls of the two assays. The gamma phage assay requires live, nonvirulent B. anthracis while the JBAIDS system uses only nucleic acid as a positive control.

In summary the JBAIDS assay, while technologically distinct from the predicate, is as safe and effective as the predicate, is easier to use, and is highly sensitive and specific.

### References

- Hoffmaster AF, Meyer RF, Bowen M, Marston CK, Weyant RS, Thurman K, et al. 1 Evaluation and validation of a real-time polymerase chain reaction assay for rapid identification of Bacillus anthracis. Emerg Infect Dis [serial online] 2002;Oct:8. Available from: URL: http://www.cdc.gov/ncidod/EID/vol8no10/02-0393.htm.
- Bell, CA, et al. Detection of Bacillus anthracis DNA by LightCycler PCR. J Clin 2 Microbiol. 2002;40:2897-2902.
- Hoffmaster AR, Ravel J, Rasko DA, Chapman GD, Chute MD, Marston CK, De BK, గా Sacchi CT, Fitzgerald C, Mayer LW, Maiden MCJ, Priest FG, Barker M, Jiang L, Cer RZ, Rilstone J, Peterson SN, Weyant RS, Galloway DR, Read TD, Popovic T, Fraser CM. Identification of anthrax toxin genes in a Bacillus cereus associated with an illness resembling inhalation anthrax. Proc Natl Acad Sci USA. 2004;101(22):8449-8454.

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Image /page/8/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

NOV 1 8 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k051713 Trade/Device Name: JBAIDS Anthrax Detection System Regulation Number: Unclassified Product Code: NHT Dated: September 29, 2005 Received: October 3, 2005

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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#### Page 2 -

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 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 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). 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,

Sale, a For

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): K051713

### Device Name: JBAIDS Anthrax Detection System

Indications For Use:

The JBAIDS Anthrax Detection System is a real-time polymerase chain reaction (PCR) test system inte on for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences on the pXO1 intended for the qualitative in viro diagnostic (Target 2) from Bacillus anthracis. The system can be used to placenia (Furgot 1) and the promotividuals suspected of having anthrax, positive test numan whole blood collected in Coulain 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 I likelihood, 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).
- or good of plasmid targets that would be present in blood from individuals with early systemic 트 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.

AND/OR - Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 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)

Division Sign-Off

Office of In Viro Diagnostic Device Evaluation and Sciety

510(k) KD517i3