(308 days)
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No
The device description and performance studies indicate a traditional immunochromatographic test based on antibody detection, with no mention of AI or ML components.
No
This device is an in vitro diagnostic test used for the rapid, qualitative detection of Bacillus anthracis, not for therapeutic purposes.
Yes
The device is described as an "in vitro qualitative detection of Bacillus anthracis" and is "intended for use in clinical, public health, and hospital laboratories in conjunction with other markers and testing for the identification of Bacillus anthracis," which directly aligns with the definition of a diagnostic device.
No
The device description clearly states it is a test cassette with a reagent strip and is supplied with physical components like test cassettes, buffer, and control reagent, indicating it is a hardware-based in vitro diagnostic test, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "in vitro qualitative detection" and "in vitro qualitative presumptive identification." This clearly indicates the test is performed outside of the body on a sample.
- Device Description: The description mentions a "reagent strip" and "test cassettes," which are components typically used in in vitro diagnostic tests.
- Intended User/Care Setting: The test is intended for use in "clinical, public health, and hospital laboratories," which are settings where in vitro diagnostic testing is performed.
The term "in vitro" is the key indicator that this device is an IVD.
N/A
Intended Use / Indications for Use
The Tetracore RedLine Anthrax Alert™ Test is intended for the rapid, in vitro qualitative detection of Bacillus anthracis from non-hemolytic colonies obtained from sheep blood agar plates. The test is intended for use in clinical, public health, and hospital laboratories in conjunction with other markers and testing for the identification of Bacillus anthracis.
Indications For Use:
The Tetracore RedLine Alert™Test is an immunochromatographic test intended for the rapid, in vitro qualitative presumptive identification of Bacillus anthracis from nonhemolytic Bacillus colonies cultured on sheep blood agar plates. The test is intended for use in clinical, public health, and hospital laboratories in conjunction with other markers and testing for the presumptive identification of Bacillus anthracis.
Warning: The RedLine Alert™ Test has not been evaluated for use with spore preparations, suspicious powders, or samples other than colonies from culture growth.
Product codes
NPO
Device Description
The RedLine Anthrax Alert™ Test Cassette includes a reagent strip consisting of a combination of monoclonal and polyclonal antibodies that selectively detect the presence of Bacillus anthracis in aqueous specimens. The RedLine Anthrax Alert™ Test is supplied with single use test cassettes, Colony Isolation Buffer, and Positive Control reagent.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical, public health, and hospital laboratories
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The RedLine Anthrax Alert™ Test Kit was found to have a sensitivity of 99% based on the testing of 145 isolates and a specificity of 100% based on the testing of 59 isolates.
Key Metrics
Sensitivity of 99%, specificity of 100%
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Tetracore, Inc. 11 Firstfield Road, Suite C Gaithersburg, MD 20878
510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with 21 CFR 807.02 and the Safe Medical Device Act of 1990.
| The assigned 510(k) number is: | K030370 |
|---|---|
| -------------------------------- | --------- |
Date of Submission
4 February, 2003
Identification of Applicant
Applicant/Distributor:
TETRACORE, INC. 11 Firstfield Road, Suite C Gaithersburg, MD 20878
Contact Person: Beverly L. Mangold, Ph.D. Tetracore, Inc. 11 Firstfield Road, Suite C Gaithersburg, MD 20878 301.258.7553 (phone) bmangold@tetracore.com (email)
| Trade or Proprietary Name | RedLine Anthrax Alert™ Test |
|---|---|
| Common Name | Bacillus anthracis detection test |
| Classification Name | Reagent; antibody; Bacillus anthracis |
| Classification | Class II |
Intended Use
The Tetracore RedLine Anthrax Alert™ Test is intended for the rapid, in vitro qualitative detection of Bacillus anthracis from non-hemolytic colonies obtained from sheep blood agar plates. The test is intended for use in clinical, public health, and hospital laboratories in conjunction with other markers and testing for the identification of Bacillus anthracis.
1
Device Description
The RedLine Anthrax Alert™ Test Cassette includes a reagent strip consisting of a combination of monoclonal and polyclonal antibodies that selectively detect the presence of Bacillus anthracis in aqueous specimens. The RedLine Anthrax Alert™ Test is supplied with single use test cassettes, Colony Isolation Buffer, and Positive Control reagent.
Substantial Equivalence
The RedLine Anthrax Alert™ Test is substantially equivalent to the following designated pre-amendment medical device:
Antibody-conjugate for the detection of Anthrax antigen
Technological Characteristics
Substantial equivalence is claimed to the designated pre-amendment medical devices as described at the Medical Devices Panel Meeting held March 7, 2002.
Performance Characteristics
The RedLine Anthrax Alert™ Test Kit was found to have a sensitivity of 99% based on the testing of 145 isolates and a specificity of 100% based on the testing of 59 isolates.
Stability
The Redline Anthrax Alert™ Test Kit is stable for twelve (12) months when stored at 15-30°C.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The HHS logo is encircled by the department's name, "U.S. Department of Health & Human Services", in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 9 - 2003
Beverly L. Mangold, Ph.D. Tetracore, Inc. 11 Firstfield Road, Suite C Gaithersburg, MD 20878
Re: K030370
Trade/Device Name: RedLine Alert 10 Test Regulation Number: Unclassified Product Code: NPO Dated: October 9, 2003 Received: October 9, 2003
Dear Dr. Mangold:
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 and lication (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 (OS) 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 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 (301) 594-3084. 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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director 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): _ K030370
Device Name: RedLine Alert™ Test
Indications For Use:
The Tetracore RedLine Alert™Test is an immunochromatographic test intended for the rapid, in vitro qualitative presumptive identification of Bacillus anthracis from nonhemolytic Bacillus colonies cultured on sheep blood agar plates. The test is intended for use in clinical, public health, and hospital laboratories in conjunction with other markers and testing for the presumptive identification of Bacillus anthracis.
Warning: The RedLine Alert™ Test has not been evaluated for use with spore preparations, suspicious powders, or samples other than colonies from culture growth.
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
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
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Division Sigh
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K030370