(142 days)
The ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Analyzer, is a qualitative and semiquantitative flocculation test for the detection of nontreponemal antibodies in human serum and plasma to aid in the diagnosis of syphilis. All reactive RPR test samples should be further tested with a treponemal test to determine serological evidence of syphilis infection. The test is intended to be used for in vitro diagnostic testing.
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 (liquid), 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.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:
This submission is for a new algorithm for an existing device, the ASI Evolution Automated Syphilis Analyzer, used with the ASI Automated RPR Test for Syphilis. The study aims to demonstrate substantial equivalence of the new algorithm to the original algorithm. Therefore, the acceptance criteria and study design are geared towards showing comparable performance rather than de novo validation against a clinical gold standard.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the goal of demonstrating substantial equivalence to the original algorithm. This means the new algorithm's performance (positive agreement and negative agreement) should be comparable to or better than the original algorithm's. While explicit numerical thresholds for acceptance are not stated for agreement, the 95% Confidence Intervals are provided, which typically are evaluated against a pre-defined acceptance range (e.g., lower bound of 90% for positive agreement). The reproducibility section demonstrates 100% agreement, which is a strong indicator of meeting a high standard for reproducibility.
Table of Acceptance Criteria (Implicit) and Reported Device Performance (Calculated from provided data)
| Performance Metric | Implicit Acceptance Criteria (Comparable to original algorithm, with high confidence) | Reported Device Performance (New Algorithm vs. Original Algorithm) |
|---|---|---|
| Retrospective Serum Samples | ||
| Serum Positive Agreement | High agreement (e.g., >90% lower bound 95% CI) | 100% (95% Cl = 96.03% - 100%) |
| Serum Negative Agreement | High agreement (e.g., >90% lower bound 95% CI) | 99.23% (95% Cl = 98.34% - 99.72%) |
| Retrospective Plasma Samples (Total) | ||
| Total Plasma Positive Agreement | High agreement (e.g., >90% lower bound 95% CI) | 95.97% (95% Cl = 90.91% - 98.27%) |
| Total Plasma Negative Agreement | High agreement (e.g., >90% lower bound 95% CI) | 99.87% (95% Cl = 99.27% - 100.00%) |
| Reproducibility | Consistent results across runs and operators | 100% reproducibility for all tested samples (60/60 for each sample, 95% CI 94.04-100) |
| End-point Titer Testing (Semiquantitative) | Within +/- 1 titer of expected result for reactive samples; Nonreactive samples must be nonreactive. | All samples (80/80 data points per sample) met the criteria. |
Details of the Study Proving Device Meets Acceptance Criteria
1. Sample Sizes Used for the Test Set and Data Provenance:
- Retrospective Study Comparing Algorithms:
- Serum Samples: 872 individual retrospective samples.
- Plasma Samples: 890 individual retrospective samples.
- Pregnant Women Testing: 280 samples (30 reactive, 250 nonreactive).
- Total Samples for Algorithm Comparison: 872 (serum) + 890 (plasma) + 280 (pregnant women) = 2042 samples.
- Reproducibility Study:
- 7 samples (2 nonreactive, 2 reactive 1:2, 1 reactive 1:4, 1 reactive 1:8, 1 reactive 1:16).
- Each sample tested in duplicate within the panel, for 5 non-consecutive days, producing 60 data points per sample (60/60 reported). Total 7 samples x 60 data points = 420 data points.
- End-point Titer Testing:
- 9 samples (2 nonreactive, 7 reactive with varying titers).
- Each sample tested in 8 replicates on 10 different days, resulting in 80 data points for each sample. Total 9 samples x 80 data points = 720 data points.
- Data Provenance: Retrospective samples, with identifiers removed, collected from different Departments of Public Health Labs and Blood Banks. No specific country of origin is mentioned, but "U.S. Food & Drug Administration" implies U.S. data.
2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- For Algorithm Equivalence Study: The "ground truth" for the algorithm comparison study was the results interpreted by the original ASI Evolution algorithm (K173376 and K182391). This device was already cleared by the FDA, implying its outputs were considered reliable. No human experts were explicitly stated to establish ground truth for this direct comparison between two algorithms. However, for discordant results:
- The 6 discordant serum results (new algorithm nonreactive, original algorithm reactive) were investigated and tested with a treponemal test and found to be reactive. This implies confirmation by an independent, more specific test, which is a common form of "ground truth" for syphilis diagnosis.
- The 6 discordant plasma results (1 new reactive/original nonreactive, 5 new nonreactive/original reactive) were investigated. The new reactive/original nonreactive sample was tested with a treponemal test and found to be nonreactive. The 5 new nonreactive/original reactive samples were attributed to bubbles or artifacts in the test well. This also points to investigation and confirmation using a more definitive test or root cause analysis, serving as a form of expert adjudication or outcome-based truth.
- For Reproducibility and End-point Titer Testing: The "Expected Result" for these tests was established either by the manual interpretation method prior to testing (for end-point titer samples) or by the known characteristics of the control samples used. This implies laboratory or subject matter expert consensus or established reference values.
3. Adjudication Method for the Test Set:
- For the algorithm comparison (serum and plasma), discordant results between the new and original algorithms were investigated using a treponemal test (for biological confirmation) or attributed to technical issues (e.g., bubbles/artifacts). This serves as an adjudication method based on a more definitive test or root cause analysis.
- For the pregnant women testing, the comparison was made against the "ASI RPR Card Test for Syphilis on the ASiManager-AT Result," which acts as the reference.
- No explicit "2+1" or "3+1" human expert adjudication method was described as the primary ground truth establishment for the algorithm comparison, as the goal was algorithm-to-algorithm equivalence rather than algorithm-to-human.
4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not performed as the primary validation for this submission. The study focused on demonstrating substantial equivalence between two automated algorithms (new vs. original ASI Evolution algorithm), not on comparing human readers with and without AI assistance.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable to this study design.
5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the core of the submission is a standalone performance study comparing the new algorithm's interpretation capabilities against the existing, cleared original algorithm on the same instrument. The "Performance Data" section explicitly states, "A comparison of the digital interpretation of the results from the ASI Evolution using the original interpretation algorithm... to establish substantial equivalence to the interpretation made by the ASI Evolution using the new interpretation algorithm was conducted."
6. The Type of Ground Truth Used:
- Algorithm vs. Algorithm (Predicate Device as Reference): The primary "ground truth" for the main algorithm comparison study was the output of the predicate device's algorithm (original ASI Evolution algorithm).
- Confirmatory Treponemal Test: For discrepant results in the algorithm comparison studies, a treponemal test was used as a more definitive clinical ground truth to resolve ambiguities.
- Manual Interpretation Methods / Known Reactivity: For reproducibility and end-point titer testing, the "expected result" was based on prior manual interpretation methods or known characteristics of control samples.
- No pathology or direct outcomes data was cited as the primary ground truth for the device clearance.
7. The Sample Size for the Training Set:
- Not specified in the provided document. The document describes a study comparing the new algorithm's performance against the old one (test set). It does not provide details about if or how the new algorithm itself was "trained" using specific data. Given the context of medical device clearance, it's presumed that the algorithm development (training, if any) would have occurred prior to this validation study.
8. How the Ground Truth for the Training Set was Established:
- Not specified in the provided document. As the training set details are not provided, neither is the method for establishing its ground truth.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
October 21, 2020
Arlington Scientific, Inc. (ASI) David Binks COO 1840 North Technology Dr. Springville, Utah 84663
Re: K201438
Trade/Device Name: ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer Regulation Number: 21 CFR 866.3820 Regulation Name: Treponema Pallidum Nontreponemal Test Reagents Regulatory Class: Class II Product Code: GMQ, Dated: May 29, 2020 Received: June 1, 2020
Dear David Binks:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Steven Gitterman, M.D., Ph.D. Deputy Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201438
Device Name
ASI Automated RPR Test for Syphilis for Use on the ASI Evolution
Indications for Use (Describe)
The ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Analyzer, is a qualitative and semiquantitative flocculation test for the detection of nontreponemal antibodies in human serum and plasma to aid in the diagnosis of syphilis. All reactive RPR test samples should be further tested with a treponemal test to determine serological evidence of syphilis infection. The test is intended to be used for in vitro diagnostic testing.
The ASI Automated RPR Test for Syphilis is for professional use only.
| 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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Arlington Scientific, Inc.
5.0 510(k) Summary
5.1 Preparation Date: 08/24/2020
Submitted By
David Binks MT (ASCP), MBA COO Arlington Scientific, Inc. 1840 North Technology Dr. Springville, UT 84663 Phone 801-489-8911 / Fax 801-489-5552
- 5.2 Trade Name –ASI Automated RPR Test for Syphilis for use on the ASI Evolution
Regulation section: (21 CFR 866.3820) Treponema pallidum nontreponemal test reagents
Classification: Class II
Product Code: GMQ
Panel: Microbiology
- 5.3 Predicate Device(s) – ASI RPR Card Test for Syphilis on the ASI Evolution (K173376, BK170114, and K182391)
| Device Similarities and Differences | ||
|---|---|---|
| Item | ASI Evolution (NewAlgorithm) (K201438) | ASI Evolution(Original Algorithm)(K173376 andK182391) |
| Intended Use | The ASI Automated RPR (rapid plasmareagin) Test for Syphilis, for use on the ASIEvolution Automated Analyzer, is aqualitative and semiquantitativeflocculation test for the detection ofnontreponemal antibodies in human serumand plasma to aid in the diagnosis ofsyphilis. All reactive RPR test samplesshould be further tested with a treponemaltest to determine serological evidence ofsyphilis infection. The test is intended tobe used for in vitro diagnostic testing.The ASI Automated RPR Test for Syphilisis for professional use only. | The ASI Automated RPR (rapidplasma reagin) Test for Syphilis,for use on the ASI EvolutionAutomated Syphilis Analyzer, isa qualitative and semi-quantitative nontreponemalflocculation test for the detectionof reagin antibodies in humanserum and plasma as ascreening test for serologicalevidence of syphilis. All reactiveRPR test samples should befurther tested with a treponemaltest. |
| TechnologyInstruments | The ASI Evolution is an integrated digitalparticle analyzer designed to objectivelyinterpret certain agglutination testsmanufactured by Arlington Scientific, Inc.(ASI). The ASI Evolution fully automatesthe sample and reagent handling steps ofthe test procedure. Laboratoryprofessionals use the ASI Evolution toprovide standardized test interpretationusing criteria that define reactive andnonreactive agglutination reactions.The ASI Evolution employs a camera tocreate a highly sensitive and high-resolution image of the agglutinationimmunoassay. This image is thenanalyzed by the proprietary softwarealgorithm to interpret the agglutinationpattern. | The ASI Automated RPR Test forSyphilis is for professional useonly. The test is intended to beused for in vitro diagnostic testingand blood donor screening.The ASI Evolution is intended tobe used as a fully automatedanalyzer to objectively interpretthe results of the ASI AutomatedRPR test for Syphilis. The ASIEvolution is designed to providestandardized test interpretationand to provide for storage,retrieval, and transmittal of thetest results. It is intended to beacquired, possessed and usedonly by health care professionals.The ASI Evolution analyzer, inconjunction with the ASIAutomated RPR Test for Syphilisis intended to be used for in vitrodiagnostic testing and blooddonor screening.Same |
| The ASI Evolution further provides toolsthat enable the creation, storage, retrievaland transmittal of the test results. | ||
| TechnologyReagents | Flocculation Test | Same |
| Antigen | ASI RPR Carbon Antigen | Same |
| Reported Results | Reactive, Nonreactive | Same |
| Interpretation | Automated | Same |
| Sample Processing | Automated | Same |
| Reagent Volumeused per Sample | 110 µl | Same |
| Sample Type | Serum or Plasma | Same |
| Controls | Reactive, Weak Reactive, Nonreactive | Same |
Device Similarities and Differences
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Arlington Scientific, Inc.
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| ASI Evolution K201438 | Arlington Scientific, Inc. | ||
|---|---|---|---|
| Test card | 48 well plastic test plate | Same | |
| Target Population | Used for in vitro diagnostic testing | Same |
- 5.4 Device Description – 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 (liquid), 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.
Intended Use -
The ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Analyzer, is a qualitative and semiquantitative flocculation test for the detection of nontreponemal antibodies in human serum and plasma to aid in the diagnosis of syphilis. All reactive RPR test samples should be further tested with a treponemal test to determine serological evidence of syphilis infection. The test is intended to be used for in vitro diagnostic testing.
The ASI Automated RPR Test for Syphilis is for professional use only.
Performance Data – A comparison of the digital interpretation of the results from the ASI Evolution using the original interpretation algorithm (K173376, BK170114, and K182391) to establish substantial equivalence to the interpretation made by the ASI Evolution using the new interpretation algorithm was conducted.
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Arlington Scientific, Inc.
The ASI Evolution was evaluated for equivalence, in its pattern of reactivity using a total of 1.762 individual retrospective samples, with identifiers removed, that had been collected from different Departments of Public Health Labs and Blood Banks. Reactive, Weak Reactive and Nonreactive controls were run on each day of testing.
Retrospective Serum Sample Testing - 872 Samples
| ASI Evolution Original Algorithm | |||
|---|---|---|---|
| Reactive | Nonreactive | ||
| ASI Evolution New Algorithm | Reactive | 91 | 6 |
| Nonreactive | 0 | 775 |
Note: The six discordant results were investigated and tested with a treponemal test and found to be reactive.
Serum positive agreement is calculated as:
91/(91 + 0) = 100% 95% Cl = 96.03% - 100%
Serum negative agreement is calculated as:
775/(775 + 6) = 99.23% 95% Cl = 98.34% - 99.72%
Serum samples were from both SST and Red Top tubes.
| ASI Evolution Original Algorithm | |||
|---|---|---|---|
| Reactive | Nonreactive | ||
| ASI Evolution New Algorithm | Reactive | 119 | 1 |
| Nonreactive | 5 | 765 |
Retrospective Plasma Sample Testing - 890 Samples
Note: The six discordant results were investigated and the sample that was called reactive by the new algorithm and nonreactive by the original algorithm was tested with a treponemal test and found to be nonreactive. The five samples that were called nonreactive by the new algorithm and reactive by the original algorithm had bubbles or artifacts in the test well.
Total Plasma positive agreement is calculated as:
119/(119 + 5) = 95.97%
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Arlington Scientific, Inc.
95% Cl = 90.91% - 98.27%
Sodium Citrate positive agreement is calculated as:
55/(55 + 4) = 93.22% 95% Cl = 83.54% - 98.12%
EDTA positive agreement is calculated as:
64/(64 + 1) = 98.46% 95% Cl = 91.72% - 99.96%
Total Plasma negative agreement is calculated as:
765/(765 + 1) = 99.87% 95% Cl = 99.27% - 100.00%
Sodium Citrate negative agreement is calculated as:
465/(465 + 1) = 99.79% 95% Cl = 98.81% - 99.99%
EDTA negative agreement is calculated as:
300/(300 + 0) = 100% 95% Cl = 98.78% - 100%
Pregnant Women Testing
| Reactive | Nonreactive | |
|---|---|---|
| ASI RPR Card Test for Syphilis on the ASiManager-AT Result | ||
| ASI Automated RPRTest for Syphilis on theASI Evolution Result | 30 | 0 |
| Reactive | ||
| Nonreactive | 0 | 250 |
Conclusion:
The positive and negative percent agreement for the two algorithms demonstrate that they have a very similar performance.
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Reproducibility
Reproducibility testing was conducted. The testing consisted of:
- Testing seven (7) samples
- 2 RPR nonreactive samples o
- o 2 RPR reactive 1:2 titered samples
- o 1 RPR reactive 1:4 titered sample
- o 1 RPR reactive 1:8 titered sample
- o 1 RPR reactive 1:16 titered sample
- Each sample was run in duplicate within the panel. .
- Each sample was tested each day for five non-consecutive days by an operator ● with experience in performing the ASI Automated RPR Test for Syphilis
- Each sample was tested a second time on each of the days referenced above . separated by approximately 2 hours.
| RPR | ||||
|---|---|---|---|---|
| Sample | Sample # | N | Expected Result | 95% Confidence Interval |
| RPR nonreactive | 10159A | 60 | 100%(60/60) | 94.04 - 100 |
| RPR nonreactive | 06127 | 60 | 100%(60/60) | 94.04 - 100 |
| RPR reactive 1:2 | 10159D | 60 | 100%(60/60) | 94.04 - 100 |
| RPR reactive 1:2 | W9P19R | 60 | 100%(60/60) | 94.04 - 100 |
| RPR reactive 1:4 | 10159C | 60 | 100%(60/60) | 94.04 - 100 |
| RPR reactive 1:8 | 10159E | 60 | 100%(60/60) | 94.04 - 100 |
| RPR reactive 1:16 | R0B03R | 60 | 100%(60/60) | 94.04 - 100 |
The data shows a very high degree of reproducibility.
End-point Titer Testing
A total of 9 samples with identifiers removed were tested to determine patterns of reactivity using the semiquantitative test procedure on the ASI Evolution with the new interpretation algorithm with the reagents of the ASI Automated RPR Test for Syphilis. There were no errors with the instrument during the testing.
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Arlington Scientific, Inc.
The nine samples were made up of prospective control serum and serum samples of known reactivity. All samples had been tested by the manual interpretation method prior to testing. The expected results were established by this testing. These specimens were tested with ASI carbon antigen (CA9P02RRD). The samples were as follows:
| Sample ID | Sample Type | Titer |
|---|---|---|
| 06127 | Normal Human Serum | Nonreactive (NR) |
| 10159A | Nonreactive Control | Nonreactive (NR) |
| 10159E | Human Serum | Reactive (1:8) |
| 10159D | Human Serum | Reactive (1:2) |
| W9P19R | Weak Reactive Control | Reactive (1:2) |
| R0B03R | Reactive Control | Reactive (1:8) |
| 01140 | Human Serum | Reactive (1:64) |
| 10159 | Human Serum | Reactive (1:128) |
| 10189C | Human Serum | Reactive (1:256) |
The nine samples were tested in eight replicates on ten different days. Not all samples were tested on the same day. Each sample set of eight replicates were tested ten times giving a total of 80 data points for each sample. The line item data is included with this submission as a separate document. An acceptable result is within +/- 1 titer of the expected result. Nonreactive samples must be nonreactive. The results of the semiquantitative analysis samples are shown in tables below:
| Titration Sample Testing | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Sample ID | 06127 | 10159A | 10159E | 10159D | W9P19R | R0B03R | 01140 | 10159 | 10189C | |
| Expected Result | NR | NR | 1:8 | 1:2 | 1:2 | 1:8 | 1:64 | 1:128 | 1:256 | |
| Run | ||||||||||
| 1 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | |
| 2 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | |
| 3 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | |
| 4 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | |
| 5 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | |
| 6 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | |
| 7 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | |
| 8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | |
| 9 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | |
| 10 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | 8/8 | |
| Total | 80/80 | 80/80 | 80/80 | 80/80 | 80/80 | 80/80 | 80/80 | 80/80 | 80/80 |
All titration samples were within the +/- one titer.
| RPREndpointManualTesting | Nonreactive | 1:1(Neat) | 1:2 | 1:4 | 1:8 | 1:16 | 1:32 | 1:64 | 1:128 | 1:256 | 1:512 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Nonreactive | 160 | ||||||||||
| 1:2 | 101 | 59 | |||||||||
| 1:8 | 20 | 120 | 20 | ||||||||
| 1:64 | 17 | 46 | 17 | ||||||||
| 1:128 | 26 | 53 | 1 | ||||||||
| 1:256 | 35 | 40 | 5 |
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Arlington Scientific, Inc.
§ 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).