(87 days)
The ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer, is a qualitative and semi-quantitative nontreponemal flocculation test for the detection of reagin antibodies in human serum and plasma as a screening test for serological evidence of syphilis. All reactive RPR test samples should be further tested with a treponemal test. The ASI Automated RPR Test for Syphilis is for professional use only. The test is intended to be used for in vitro diagnostic testing and blood donor screening.
The ASI Evolution is intended to be used as a fully automated analyzer to objectively interpret the results of the ASI Automated RPR Test for Syphilis. The ASI Evolution is designed to provide standardized test interpretation and to provide for storage, retrieval, and transmittal of the test results. It is intended to be acquired, possessed and used only by health care professionals. The ASI Evolution analyzer, in conjunction with the ASI Automated RPR Test for Syphilis is intended to be used for in vitro diagnostic testing and blood donor screening.
The Automated RPR Test for Syphilis performed on the ASI Evolution is an automated nontreponemal flocculation test for the detection of reqain antibodies in human serum and plasma.
The ASI Evolution is an integrated digital particle analyzer designed to objectively interpret certain slide agglutination tests manufactured by Arlington Scientific, Inc. (ASI). The ASI Evolution fully automates the sample and reagent handling steps of the test procedure. Qualitative and semiquantitative tests are performed by laboratory professionals who use the ASI Evolution to provide standardized test interpretation using criteria that define reactive and nonreactive agglutination reactions.
The ASI Evolution employs a camera that uses light reflectance to create a highly sensitive and high-resolution image of the agglutination immunoassay. This image is then analyzed by the proprietary software algorithm to interpret the agglutination pattern.
The ASI Evolution further provides tools that enable the creation, storage, retrieval and transmittal of the test results.
The ASI Automated RPR Test for Syphilis reagents include the following:
CARBON ANTIGEN - 0.003% cardiolipin, 0.020-0.022% lecithin, 0.09% cholesterol, charcoal (activated) as visual enhancer, phosphate buffer, 0.1% sodium azide as preservative and stabilizers.
CONTROLS (REACTIVE, WEAK REACTIVE, NONREACTIVE) - Human serum or defibrinated plasma (liguid), with 0.1% sodium azide as preservative.
Reagents have two-year expiration dating from date of manufacture. The specific expiration date is located on the label on the vial.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the ASI Automated RPR Test for Syphilis on the ASI Evolution, specifically focusing on the semi-quantitative claim for endpoint titer determination.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All non-reactive samples must yield non-reactive test results. | 100% of non-reactive samples (160 out of 160) yielded non-reactive test results. |
| All reactive samples must yield test results within one dilution above or below the known titer. | 100% of reactive samples yielded test results within one dilution of the known titer. (Overall agreement of 100% with a 95% C.I. for individual samples ranges from 95.49% to 100%). |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Description: A randomized and blinded panel of 10 human serum samples with known reagin antibody endpoint titers.
- Sample Size: Each of the 10 samples was tested a minimum of 80 times, for a total of 800 tests (10 samples * 80 tests/sample).
- 2 of the 10 samples were non-reactive (total 160 non-reactive tests).
- 8 of the 10 samples were reactive (total 640 reactive tests).
- Data Provenance: The tests were performed in-house on at least five different days by one operator using a single ASI Evolution instrument. The origin of the human serum samples themselves (e.g., country of origin) is not explicitly stated, but they are described as having "known reagin antibody endpoint titers." The study can be considered prospective as it involved testing pre-selected samples with the device to determine its performance against established ground truth.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The ground truth for the 10 human serum samples (known reagin antibody endpoint titers) was "determined by the ASI RPR Card Test for Syphilis on the ASiManager-AT."
- The document does not explicitly state the number or qualifications of experts used to establish the ground truth via the ASI RPR Card Test on the ASiManager-AT. It implies that this was an established method of determining titers, rather than an expert consensus process for this specific study.
4. Adjudication Method for the Test Set
- None specified. The study setup describes the device's output being compared directly against the "known reagin antibody endpoint titers" established by the ASiManager-AT, implying a direct comparison rather than an adjudication process between human readers or the device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The provided text describes an analytical study evaluating the semi-quantitative performance (endpoint titer validation) of the automated system. It does not include an MRMC study comparing human reader performance with and without AI assistance for this specific indication.
- The document mentions "Clinical performance of the ASI Automated RPR Test for Syphilis on the ASI Evolution was evaluated under K173376," but focuses on overall qualitative detection rather than human reader AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes. The described study is a standalone performance evaluation of the ASI Evolution device itself, as it automates the interpretation of the RPR test. The device's proprietary software algorithm analyzes the image and interprets the agglutination pattern to report results (Reactive, Nonreactive, endpoint titers).
7. Type of Ground Truth Used
- The ground truth used was "known reagin antibody endpoint titers," which were "determined by the ASI RPR Card Test for Syphilis on the ASiManager-AT." This can be classified as a reference standard method (another established diagnostic test) rather than direct pathology or outcomes data from patients.
8. Sample Size for the Training Set
- The sample size for the training set is not specified in the provided text. The document describes pre-market validation for the analytical performance and refers to previous clinical performance evaluations (K173376) for qualitative detection. It does not provide details on the data used to train the proprietary software algorithm itself.
9. How the Ground Truth for the Training Set Was Established
- As the training set size is not specified, how its ground truth was established is also not detailed in this document. It is implicitly understood that for an automated system, the training data would also require established ground truth to enable the algorithm to learn to interpret agglutination patterns, but the specifics are not provided here.
§ 866.3820
Treponema pallidum nontreponemal test reagents.(a)
Identification. Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).