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.

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.

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.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines the acceptance criteria through the reported performance characteristics.

Acceptance Criteria (Implied)	Reported Device Performance
High Sensitivity	99% Sensitivity
High Specificity	100% Specificity
Stability for a defined period	12 months stability at 15-30°C

2. Sample Size Used for the Test Set and Data Provenance:

Test set sample size:
- Sensitivity: 145 isolates
- Specificity: 59 isolates
Data Provenance: Not explicitly stated. Given it's a 510(k) submission, the isolates would likely be from laboratory cultures and potentially clinical samples, but the geographic origin or whether they were retrospective/prospective is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The document refers to "isolates" and their characteristics, implying that the ground truth for these isolates (i.e., whether they definitively were Bacillus anthracis or another species) was previously established, but the method and expertise involved are not detailed.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method. The testing appears to have been directly against the established identification of the isolates.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This device is a diagnostic test (an immunochromatographic assay) designed for automated or semi-automated qualitative detection, not for human interpretation that would be improved by AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the performance characteristics reported (sensitivity and specificity) are for the standalone device (RedLine Anthrax Alert™ Test) without human interpretation affecting the result. The device itself produces the qualitative result.

7. The Type of Ground Truth Used:

The ground truth used was based on the identity of the bacterial isolates from "non-hemolytic colonies obtained from sheep blood agar plates." This implies a microbiological gold standard, likely established through traditional microbiological identification methods (e.g., Gram staining, cultural characteristics, biochemical tests, molecular methods) which are considered definitive for bacterial species identification. The document does not explicitly state "pathology" or "outcomes data" but rather relies on confirmed bacterial identity.

8. The Sample Size for the Training Set:

The document does not provide information regarding a separate training set size. The reported performance is based on the "testing of 145 isolates" and "59 isolates," which constitute the evaluation/test set. For a lateral flow immunochromatographic assay, the development and optimization (which could be considered a form of "training") might involve a different process than machine learning algorithms, often relying on reagent optimization and preliminary analytical studies.

9. How the Ground Truth for the Training Set Was Established:

As a separate training set is not explicitly mentioned, the ground truth for any development or optimization phases would likely have been established using the same (or similar) microbiological gold standard as described for the test set (i.e., definitive identification of Bacillus anthracis and other relevant bacterial species).

Summary

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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
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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

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Device Description

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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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 (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:

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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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K030370

Regulation Number and Section

§ 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.