(87 days)
No
The summary mentions a "proprietary software algorithm" for image analysis but does not use terms like AI, ML, or deep learning, nor does it describe characteristics typically associated with AI/ML development (e.g., training data, model architecture). The description of the algorithm's function aligns more with traditional image processing and pattern recognition based on predefined criteria.
No.
This device is an in vitro diagnostic (IVD) device used for screening for serological evidence of syphilis. It is used to detect reagin antibodies in human serum and plasma and provides standardized test interpretation. It does not provide any therapy or treatment.
Yes
The device, the ASI Automated RPR Test for Syphilis used on the ASI Evolution, is explicitly stated for "detection of reagin antibodies in human serum and plasma as a screening test for serological evidence of syphilis" and is for "in vitro diagnostic testing and blood donor screening." This indicates its role in identifying a medical condition.
No
The device description explicitly states that the ASI Evolution is an "integrated digital particle analyzer" that "fully automates the sample and reagent handling steps" and "employs a camera that uses light reflectance". This indicates the presence of significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the test is "intended to be used for in vitro diagnostic testing and blood donor screening." It also describes the test as 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." This clearly indicates that the device is used to examine specimens derived from the human body to provide information for the diagnosis of a disease (syphilis).
- Device Description: The description details the components of the test (reagents) and how the analyzer processes human serum and plasma samples to detect antibodies.
- Performance Studies: The document describes clinical and analytical studies conducted to evaluate the performance of the device using human samples.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GMQ, JQT
Device Description
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.
Mentions image processing
The ASI Evolution employs a camera 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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Light reflectance (camera image)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use only / health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A randomized and blinded panel of 10 human serum samples with known reagin antibody endpoint titers, as determined by the ASI RPR Card Test for Syphilis on the ASiManager-AT, was tested with the ASI Automated RPR Test for Syphilis on the ASI Evolution using the semi-quantitative test procedure. The reactive samples had titers ranging from 1:1 to 1:256. Each sample panel member was tested a minimum of 80 times, in-house, on at least five different days by one operator using a single ASI Evolution instrument.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Endpoint Titer Validation:
Study Type: In-house validation testing.
Sample Size: 10 human serum samples, each tested a minimum of 80 times.
Key Results: All non-reactive samples (160 total tests) yielded non-reactive test results. All reactive samples produced test results that were within one dilution of the known reagin antibody titer, for an overall percent agreement of 100%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Percentage agreement with known titer for semi-quantitative claims: 100%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Indications for Use
510(k) Number (if known)
Device Name
Indications for Use (Describe)
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: 10/15/2018
Submitted By
David Binks MT (ASCP), MBA COO/Vice President Regulatory Affairs 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/ASI Evolution
Regulation section: (21 CFR 866.3820) Treponema pallidum nontreponemal test reagents
Classification: Class II
Product Code: GMQ
Panel: Microbiology
Previous ASI Evolution Clearance – K173376
- 5.3 Predicate Device(s) - Gold Standard Diagnostics AIX1000 RPR Automated Test System (K150358)
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Arlington Scientific, Inc.
| Device Similarities and Differences | ||
|---|---|---|
| Item | ASI Automated RPR Test for Syphilis on the | |
| ASI Evolution | Gold Standard Diagnostics AIX1000 | |
| RPR Automated Test System | ||
| Intended Use | 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 Gold Standard Diagnostics | |
| AIX1000 Rapid Plasma Reagin (RPR) | ||
| Automated Test System is a non- | ||
| treponemal flocculation test that can | ||
| qualitatively determine the presence of | ||
| reagin antibodies in human serum. It | ||
| may be used to aid in the diagnosis of | ||
| syphilis when used in conjunction with | ||
| supplemental treponemal laboratory | ||
| tests and other clinical information. | ||
| This test may also be used to detect | ||
| non-treponemal antibodies in samples | ||
| serially diluted to establish titer | ||
| information. This test is not intended | ||
| for screening blood or tissue donors. | ||
| Technology | ||
| Instruments | The ASI Evolution is an integrated digital | |
| particle analyzer designed to objectively | ||
| interpret certain agglutination tests | ||
| manufactured by Arlington Scientific, Inc. (ASI). | ||
| The ASI Evolution fully automates the sample | ||
| and reagent handling steps of the test | ||
| procedure. Laboratory professionals use the | ||
| ASI Evolution to provide standardized test | ||
| interpretation using criteria that define reactive | ||
| and nonreactive agglutination reactions. | ||
| The ASI Evolution employs a camera 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 AIX1000 is a fully automated | |
| microtiter plate processor that is able | ||
| to completely perform sample | ||
| processing steps, including dilutions, | ||
| dispenses, and incubations. The AIX | ||
| uses a probe-mounted camera to take | ||
| high resolution images to provide | ||
| photographic measurement and | ||
| analysis of agglutination. The AIX1000 | ||
| software automatically interprets | ||
| captured well images and reports them | ||
| as Non-reactive, Reactive, Invalid, or | ||
| Skipped, based on a complex | ||
| interpretation algorithm. | ||
| Technology Reagents | Nontreponemal Macroscopic Flocculation Test | Same |
| Antigen | Cardiolipin, lecithin, and cholesterol with | |
| activated carbon | Same | |
| Reported Results | Reactive, Nonreactive, endpoint titers | Same |
| Interpretation | Automated | Same |
| Sample Processing | Automated | Same |
| Sample Type | Serum or Plasma | Serum only |
| Controls | Reactive, Weak Reactive, Nonreactive | Reactive, Nonreactive |
| Test card | 48 well plastic test plate | Same |
| Indications for use | Used for in vitro diagnostic testing and blood | |
| donor testing. | Used for in vitro diagnostics Testing |
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5.4 Device Description - 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.
Intended Use – The ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer, is a qualitative 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 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.
ર્સ રે Clinical Data -
Clinical performance of the ASI Automated RPR Test for Syphilis on the ASI Evolution was evaluated under K173376. The study cohort consisted of 1068 prospective serum samples, 10 retrospective serum samples, 1003 retrospective plasma samples, 143 clinically diagnosed syphilis patients, and 250 pregnant women. For additional details and study results, please refer to the K173376 decision summary document.
5.6 Analytical Data -
Analytical studies supporting the qualitative detection of reagin antibodies in human plasma and serum by the ASI Automated RPR Test for Syphilis performed on the ASI Evolution were previously submitted and reviewed under K173376. Details pertaining to the study protocols and resulting data are available in the K173376 decision summary document. In addition to the previously conducted studies, validation testing to support the semi-quantitative claim for the determination of reagin antibody endpoint titers in human serum and plasma was performed. A description of the study protocol and a summary of the test results are provided below.
Endpoint Titer Validation
A randomized and blinded panel of 10 human serum samples with known reagin antibody endpoint titers, as determined by the ASI RPR Card Test for Syphilis on the ASiManager-AT, was tested with the ASI Automated RPR Test for Syphilis on the ASI Evolution using the semi-quantitative test procedure. The reactive samples had titers ranging from 1:1 to 1:256. Each sample panel member was tested a minimum of 80 times, in-house, on at
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Arlington Scientific, Inc.
least five different days by one operator using a single ASI Evolution instrument. To meet the acceptance criteria, all non-reactive samples were required to yield non-reactive test results, while all reactive samples were required to yield test results within one dilution above or below the known titer. The results of the semi-quantitative analysis are shown below.
| Endpoint Titer Results | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | ||||||||||||
| Reactivity | Non- | |||||||||||
| reactive | Neat | |||||||||||
| (1:1) | 1: | |||||||||||
| 2 | 1: | |||||||||||
| 4 | 1: | |||||||||||
| 8 | 1:1 | |||||||||||
| 6 | 1:3 | |||||||||||
| 2 | 1:6 | |||||||||||
| 4 | 1:12 | |||||||||||
| 8 | 1:25 | |||||||||||
| 6 | 1:51 | |||||||||||
| 2 | % Agreement | |||||||||||
| within +/- 1 | ||||||||||||
| titer (95% C.I.) | ||||||||||||
| 06127 | ||||||||||||
| (Non- | ||||||||||||
| reactive) | 80 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100% |
| (95.49% - | ||||||||||||
| 100%) | ||||||||||||
| N8E23 | ||||||||||||
| (Non- | ||||||||||||
| reactive) | 80 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100% |
| (95.49% - | ||||||||||||
| 100%) | ||||||||||||
| W6A16R | ||||||||||||
| (1:2) | 0 | 7 | 69 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100% |
| (95.49% - | ||||||||||||
| 100%) | ||||||||||||
| W8B01R | ||||||||||||
| (1:2) | 0 | 0 | 75 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100% |
| (95.49% - | ||||||||||||
| 100%) | ||||||||||||
| R7F01R | ||||||||||||
| (1:8) | 0 | 0 | 0 | 0 | 76 | 4 | 0 | 0 | 0 | 0 | 0 | 100% |
| (95.49% - | ||||||||||||
| 100%) | ||||||||||||
| R8B01R | ||||||||||||
| (1:8) | 0 | 0 | 0 | 32 | 48 | 0 | 0 | 0 | 0 | 0 | 0 | 100% |
| (95.49% - | ||||||||||||
| 100%) |
Table 3: Results from Endpoint Titer Validation Study
Non-reactive test results were observed for all 160 non-reactive samples. In addition, all reactive samples produced test results that were within one dilution of the known regain antibody titer for an overall percent agreement of 100%.
5
Image /page/5/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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.
November 30, 2018
Arlington Scientific, Inc. (ASI) David Binks, COO/VP Regulatory 1840 North Technology Dr. Springville, Utah 84663
Re: K182391
Trade/Device Name: ASI Automated RPR (rapid plasma reagin) Test for Syphilis 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, JQT Dated: September 4, 2018 Received: September 4, 2018
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
6
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Uwe Scherf, Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure