ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer

K201438 · Arlington Scientific, Inc. (Asi) · GMQ · Oct 21, 2020 · Microbiology

Device Facts

• Record ID: K201438
• Device Name: ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
• Applicant: Arlington Scientific, Inc. (Asi)
• Product Code: GMQ · Microbiology
• Decision Date: Oct 21, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3820
• Device Class: Class 2

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.

Device Story

ASI Evolution is an integrated digital particle analyzer for slide agglutination tests. It automates sample/reagent handling, mixing, timing, image capture, and result reporting. The system uses a camera to capture high-resolution images of agglutination immunoassays in microwell plates. Proprietary software identifies well boundaries, analyzes carbon particle agglutination patterns (size/number), and compares counts against preset parameters to classify results as Reactive or Nonreactive. The device is used in clinical settings by healthcare professionals. Output is displayed on a user interface, with options for printouts or file exports. Reactive samples can be batched for automated titer determination. The system improves standardization of test interpretation and facilitates result storage/retrieval.

Clinical Evidence

Bench testing only. Retrospective study of 1,762 samples (872 serum, 890 plasma) compared new algorithm to original. Serum positive agreement 100% (95% CI: 96.03-100%), negative agreement 99.23% (95% CI: 98.34-99.72%). Plasma positive agreement 95.97%, negative agreement 99.87%. Reproducibility testing (7 samples, 60 replicates each) showed 100% agreement with expected results. Endpoint titer testing (9 samples, 80 replicates each) showed 100% of results within +/- 1 titer of expected.

Technological Characteristics

Integrated digital particle analyzer; uses optical recognition and image processing to interpret agglutination assays. Employs a camera for high-resolution image capture. Software-based interpretation compares carbon particle agglutination patterns against preset thresholds. Operates on serum/plasma samples in 48-well microwell plates. Complies with IEC 61010-1, IEC 61010-2-101, and IEC 61326-1/2-6 standards. Connectivity includes barcode scanner input and file export capabilities.

Indications for Use

Indicated for qualitative and semiquantitative detection of nontreponemal antibodies in human serum and plasma to aid in syphilis diagnosis. For professional use only. All reactive samples require follow-up treponemal testing.

Regulatory Classification

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 genus Treponema and provides epidemiological information on syphilis.

Predicate Devices

• ASI RPR Card Test for Syphilis on the ASI Evolution (K173376, BK170114, and K182391)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) |
|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 [phone] / Fax [phone]

- 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 (New<br>Algorithm) (K201438) | ASI Evolution<br>(Original Algorithm)<br>(K173376 and<br>K182391) |
| Intended Use | The ASI Automated RPR (rapid plasma<br>reagin) Test for Syphilis, for use on the ASI<br>Evolution Automated Analyzer, is a<br>qualitative and semiquantitative<br>flocculation test for the detection of<br>nontreponemal antibodies in human serum<br>and plasma to aid in the diagnosis of<br>syphilis. All reactive RPR test samples<br>should be further tested with a treponemal<br>test to determine serological evidence of<br>syphilis infection. The test is intended to<br>be used for in vitro diagnostic testing.<br><br>The ASI Automated RPR Test for Syphilis<br>is for professional use only. | The ASI Automated RPR (rapid<br>plasma reagin) Test for Syphilis,<br>for use on the ASI Evolution<br>Automated Syphilis Analyzer, is<br>a qualitative and semi-<br>quantitative nontreponemal<br>flocculation test for the detection<br>of reagin antibodies in human<br>serum and plasma as a<br>screening test for serological<br>evidence of syphilis. All reactive<br>RPR test samples should be<br>further tested with a treponemal<br>test. |
| Technology<br>Instruments | The ASI Evolution is an integrated digital<br>particle analyzer designed to objectively<br>interpret certain agglutination tests<br>manufactured by Arlington Scientific, Inc.<br>(ASI). The ASI Evolution fully automates<br>the sample and reagent handling steps of<br>the test procedure. Laboratory<br>professionals use the ASI Evolution to<br>provide standardized test interpretation<br>using criteria that define reactive and<br>nonreactive agglutination reactions.<br>The ASI Evolution employs a camera to<br>create a highly sensitive and high-<br>resolution image of the agglutination<br>immunoassay. This image is then<br>analyzed by the proprietary software<br>algorithm to interpret the agglutination<br>pattern. | The ASI Automated RPR Test for<br>Syphilis is for professional use<br>only. The test is intended to be<br>used for in vitro diagnostic testing<br>and blood donor screening.<br>The ASI Evolution is intended to<br>be used as a fully automated<br>analyzer to objectively interpret<br>the results of the ASI Automated<br>RPR test for Syphilis. The ASI<br>Evolution is designed to provide<br>standardized test interpretation<br>and to provide for storage,<br>retrieval, and transmittal of the<br>test results. It is intended to be<br>acquired, possessed and used<br>only by health care professionals.<br>The ASI Evolution analyzer, in<br>conjunction with the ASI<br>Automated RPR Test for Syphilis<br>is intended to be used for in vitro<br>diagnostic testing and blood<br>donor screening.<br>Same |
| | The ASI Evolution further provides tools<br>that enable the creation, storage, retrieval<br>and transmittal of the test results. | |
| Technology<br>Reagents | Flocculation Test | Same |
| Antigen | ASI RPR Carbon Antigen | Same |
| Reported Results | Reactive, Nonreactive | Same |
| Interpretation | Automated | Same |
| Sample Processing | Automated | Same |
| Reagent Volume<br>used 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 <i>in vitro</i> 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 RPR<br>Test for Syphilis on the<br>ASI 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%<br>(60/60) | 94.04 - 100 |
| RPR nonreactive | 06127 | 60 | 100%<br>(60/60) | 94.04 - 100 |
| RPR reactive 1:2 | 10159D | 60 | 100%<br>(60/60) | 94.04 - 100 |
| RPR reactive 1:2 | W9P19R | 60 | 100%<br>(60/60) | 94.04 - 100 |
| RPR reactive 1:4 | 10159C | 60 | 100%<br>(60/60) | 94.04 - 100 |
| RPR reactive 1:8 | 10159E | 60 | 100%<br>(60/60) | 94.04 - 100 |
| RPR reactive 1:16 | R0B03R | 60 | 100%<br>(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.

| RPR<br>Endpoint<br>Manual<br>Testing | Nonreactive | 1:1<br>(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.