(308 days)
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.
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.
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).
§ 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.