(119 days)
Not Found
No
The device description details a biological assay based on bacteriophage lysis, with no mention of computational analysis, algorithms, or machine learning techniques.
No.
The device is described as an assay for the identification of Bacillus anthracis, which is a diagnostic purpose, not a therapeutic one. It's used to identify bacteria, not treat a condition or disease.
Yes
The device "can be used on suspect non-hemolytic, aerobic, gram-positive, 'ground-glass'- appearing colonies from sheep blood agar in conjunction with other markers and testing for the identification of Bacillus anthracis." This indicates its purpose is to aid in identifying a specific pathogen, which falls under diagnostic use.
No
The device description explicitly lists physical materials and equipment required for the assay, indicating it is a physical kit and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the assay is used "for the identification of Bacillus anthracis" on suspect colonies from a culture medium (sheep blood agar). This is a diagnostic purpose, aiming to identify a specific pathogen in a biological sample (bacterial colonies).
- Device Description: The device description details a reagent (Gamma Phage Suspension) and controls (Positive and Negative Controls) that are used in a laboratory setting to perform a test on a biological sample.
- Materials Supplied: The supplied materials are reagents and controls specifically designed for performing the assay.
- Materials Required but not Supplied: These are standard laboratory materials needed to perform the test.
- Equipment Required: The required equipment is standard laboratory equipment used for performing in vitro diagnostic tests.
- Intended User / Care Setting: The intended users are designated laboratories (LRN and DoD), which are settings where diagnostic testing is performed.
- Predicate Device: The mention of a predicate device (K051794; Gamma Phage Lysis for the Identification of Bacillus anthracis) strongly indicates that this device is also considered an IVD, as predicate devices are used to demonstrate substantial equivalence for regulatory purposes for similar devices.
All of these factors align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. While the sample here is bacterial colonies from a culture, the ultimate goal is to identify a pathogen that can affect humans, making it relevant to human health and thus falling under the scope of IVDs.
N/A
Intended Use / Indications for Use
The Gamma Phage assay is a lytic phage assay specific for Bacillus anthracis. The Gamma Phage assay (common name) can be used on suspect non-hemolytic, aerobic, gram-positive, "ground-glass"- appearing colonies from sheep blood agar in conjunction with other markers and testing for the identification of Bacillus anthracis. The assay is not intended for screening of blood or plasma donors.
Use of this assay is limited to designated laboratories within the Laboratory Response Network (LRN) and Department of Defense (DOD).
Product codes (comma separated list FDA assigned to the subject device)
NVQ
Device Description
The gamma phage is a lytic bacteriophage which binds to specific cell-surface components of susceptible bacteria. Their DNA is injected into the bacterium. The gamma phage replicate within the bacterium and produce PlyG lysine (2), resulting in lysis of the infected cell and release of phage. The release of newly synthesized phage leads to another round of phage infection and lysis.
Materials Supplied:
- Bacillus anthracis Gamma Phage Suspension, 0.5 ml
- . Positive Control, Bacillus anthracis Pasteur Strain Spore Suspension, 1.0 ml
- Negative Control, Bacillus cereus Spore Suspension, 1.0 ml
Materials required but not supplied:
- . 5% Sheep Blood Agar plate
- . Inoculating loops, 1ul and 10 ul
- Aerosol resistant pipette tips
- . Disinfectant
Equipment required:
- Pipettor, 5-50 µ1
- Incubator, 35+/- 2 °C
- Biological Safety Cabinet, Class II
- Refrigerator, 2-8 ℃ .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Use of this assay is limited to designated laboratories within the Laboratory Response Network (LRN) and Department of Defense (DOD).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3045 In vitro diagnostic device for
Bacillus spp. detection.(a)
Identification. An in vitro diagnostic device forBacillus species (spp.) detection is a prescription device used to detect and differentiate amongBacillus spp. and presumptively identifyB. anthracis and otherBacillus spp. from cultured isolates or clinical specimens as an aid in the diagnosis of anthrax and other diseases caused byBacillus spp. This device may consist ofBacillus spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to presumptively identify bacillus-like organisms in clinical specimens; bacteriophage used for differentiatingB. anthracis from otherBacillus spp. based on susceptibility to lysis by the phage; or antigens used to identify antibodies toB. anthracis (anti-toxin and anti-capsular) in serum. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused byB. anthracis, and gastrointestinal disease and non-gastrointestinal infections caused byB. cereus. (b)
Classification. Class II (special controls). The special controls are set forth in FDA's special controls guideline document entitled “In Vitro Diagnostic Devices forBacillus spp. Detection; Class II Special Controls Guideline for Industry and Food and Drug Administration Staff.” For availability of the guideline document, see § 866.1(e).(c)
Restriction on Distribution. The distribution of these devices is limited to laboratories that follow public health guidelines that address appropriate biosafety conditions, interpretation of test results, and coordination of findings with public health authorities.(d)
Restriction on Use. The use of this device is restricted to prescription use and must comply with the following:(1) The device must be in the possession of:
(i)(A) A person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or
(B) A practitioner, such as a physician, licensed by law to use or order the use of such device; and
(ii) The device must be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.
(2) The label of the device shall bear the statement “Caution: Federal law restricts this device to sale by or on the order of a ____”, the blank to be filled with the word “physician” or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device.
(3) Any labeling, as defined in section 201(m) of the Federal Food, Drug, and Cosmetic Act, whether or not it is on or within a package from which the device is to be dispensed, distributed by, or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or purports to furnish information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. This information will not be required on so-called reminder-piece labeling which calls attention to the name of the device but does not include indications or other use information.
(4) All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
THE SURGEON GENERAL, DEPARTMENT OF THE ARMY KENNETH BERTRAM, MD, PHD PRINCIPAL ASSISTANT FOR ACQUISITION 1430 VETERANS DRIVE FORT DETRICK MD 21702-5009
April 16, 2015
Re: K143592
Trade/Device Name: Gamma Phage Lysis Assay For The Identification Of Bacillus Anthracis Regulatory Class: unclassified Product Code: NVQ Dated: December 17, 2014 Received: December 18, 2014
Dear Dr. Bertram:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Uwe Scherf – S for
Sally Hojvat, M. Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143592
Device Name
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS
Indications for Use (Describe)
The Gamma Phage assay is a lytic phage assay specific for Bacillus anthracis. The Gamma Phage assay (common name) can be used on suspect non-hemolytic, aerobic, gram-positive, "ground-glass"- appearing colonies from sheep blood agar in conjunction with other markers and testing for the identification of Bacillus anthracis. The assay is not intended for screening of blood or plasma donors.
Use of this assay is limited to designated laboratory Response Network (LRN) and Department of Defense (D0D).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
Gamma Phage Lysis for the Identification of Bacillus anthracis
| Submitted by: | Office of Surgeon General, Department of Army |
|---|---|
| Sponsor's Representative | Kenneth A. Bertram, MD, PhD |
| Principal Assistant for Acquisition | |
| U.S. Army Medical Research and Materiel Command (USAMRMC) | |
| 1430 Veterans Drive | |
| Fort Detrick, MD 21702-5009 | |
| Primary Contact: | Robert E. Miller, PhD, RAC |
| Division of Regulated Activities and Compliance | |
| 1430 Veterans Drive | |
| Fort Detrick, MD 21702-5009 | |
| Telephone: 301-619-0317 | |
| Fax: 301-619-0197 | |
| Email: usarmy.detrick.medcom-usammda.mbx.usamrmc-regulatory- | |
| affairs@mail.mil | |
| Secondary Contact: | Chandar Thakur, PhD RAC |
| Division of Regulated Activities and Compliance | |
| 1430 Veterans Drive | |
| Fort Detrick, MD 21702-5009 | |
| Telephone: 301-619-0317 | |
| Fax: 301-619-0197 | |
| Email: usarmy.detrick.medcom-usammda.mbx.usamrmc-regulatory- | |
| affairs@mail.mil | |
| Manufacturer: | Mark Wolcott, PhD MT(ASCP) |
| United States Army Medical Research Institute of Infectious Diseases | |
| (USMRIID) | |
| Diagnostic Systems Division | |
| 1425 Porter Street | |
| Ft. Detrick, MD 21702 | |
| Telephone: 301-619-4738 | |
| Date Prepared: | 04/09/2015 |
4
| Trade Name: | Gamma Phage Lysis for the Identification of Bacillus anthracis |
|---|---|
| Common Name: | Bacillus anthracis Culture, Controls |
| Classification Name: | Bacteriophage And Controls, B. anthracis Lysis |
| Submission Type: | Special 510k |
| Device Class: | Unclassified |
| Product Code: | NVQ |
| Predicate Device: | K051794 |
| Gamma Phage Lysis for the Identification of Bacillus anthracis |
Indications for Use
The Gamma Phage assay is a lytic phage assay specific for Bacillus anthracis. The Gamma Phage assay (common name) can be used on suspect non-hemolytic, aerobic, gram-positive, "ground-glass"appearing colonies from sheep blood agar in conjunction with other markers and testing for the identification of Bacillus anthracis. The assay is not intended for screening of blood or plasma donors.
Use of this assay is limited to designated laboratories within the Laboratory Response Network (LRN) and Department of Defense (D0D).
Device Description and Comparison
The gamma phage is a lytic bacteriophage which binds to specific cell-surface components of susceptible bacteria. Their DNA is injected into the bacterium. The gamma phage replicate within the bacterium and produce PlyG lysine (2), resulting in lysis of the infected cell and release of phage. The release of newly synthesized phage leads to another round of phage infection and lysis.
Materials Supplied:
- Bacillus anthracis Gamma Phage Suspension, 0.5 ml
- . Positive Control, Bacillus anthracis Pasteur Strain Spore Suspension, 1.0 ml
- Negative Control, Bacillus cereus Spore Suspension, 1.0 ml ●
Materials required but not supplied:
- . 5% Sheep Blood Agar plate
- . Inoculating loops, 1ul and 10 ul
- Aerosol resistant pipette tips
- . Disinfectant
Equipment required:
- Pipettor, 5-50 µ1
5
- Incubator, 35+/- 2 °C
- Biological Safety Cabinet, Class II
- Refrigerator, 2-8 ℃ .
The only modification that was made is a change to the positive control strain (listed above), from the specified Pasteur strain, to the Sterne strain. The change in positive control strain does not impact the performance of the assay and does not substantially alter the 510k Premarket Notification Submission.
Substantial Equivalence:
The modified Gamma Phage Lysis for the Identification of Bacillus anthracis has the same characteristics to those which previously received 510(k) concurrence:
- Have the same indication for use
- . Use the same operating principle
- Incorporate the same materials , and equipment
- Has the same specimen collection and preparation instruction ●
The assay differs in that a new positive control strain, from specified Pasteur strain, to the Sterne stain.
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| Feature | K051794
Predicate Device | K143592
Proposed Device |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Positive Control | Bacillus anthracis Pasteur strain
spore suspension 1.0 ml
(BC3132) | Bacillus anthracis Sterne strain
viable lyophilized cells (BC3366)
Colorado Serum Company
(19102) Anthrax Spore Vaccine
- 1.0 ml suspension of viable
Bacillus anthracis Sterne strain
34F2 spores |
| Negative Control | Bacillus cereus spore
suspension 1.0 ml (BC3133) | Bacillus cereus spore
suspension 1.0 ml (BC3133) -
same
Bacillus cereus lyophilized cells
(BC3367)
ATCC 14579 - Bacillus cereus
freeze-dried (lyophilized) |
| Reporting - Capsule Staining
Techniques | A positive gamma phage result,
in conjunction with a positive
result for capsule, is considered
confirmatory identification of B.
anthracis. Capsule may be
demonstrated by colony
morphology on bicarbonate agar
after incubation in enhanced
CO2 or by staining techniques
(India ink, M'Fadyean, or
capsule DFA). | A positive gamma phage result,
in conjunction with a positive
result for capsule, is considered
confirmatory identification of B.
anthracis. Capsule may be
demonstrated by colony
morphology on bicarbonate agar
after incubation in enhanced
CO2 or by staining techniques
(India ink or M'Fadyean).
Difference - Capsule DFA
removed. |
Table of Differences Compared to Original Submission (K051794)