ASIMANAGER - AT

K111356 · Arlington Scientific, Inc. · JQT · Nov 9, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111356
• Device Name: ASIMANAGER - AT
• Applicant: Arlington Scientific, Inc.
• Product Code: JQT · Clinical Chemistry
• Decision Date: Nov 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2400
• Device Class: Class 1

Intended Use

The ASiManger-AT is intended to be used as an integrated digital particle analyzer to objectively interpret the ASI RPR Card Test for syphilis. The ASiManger-AT is designed to provide standardized test interpretation, an initial predictive titer analysis, and provides for storage, retrieval and transmittal of the test results. It is intended to be acquired, possessed and used only by healthcare professionals. For in vitro Diagnostic Use Only, not intended for screening blood and tissue donors.

Device Story

ASiManager-AT is an integrated digital particle analyzer for objective interpretation of ASI RPR Card Test for Syphilis. Device uses CCD camera to capture high-resolution light reflectance images of agglutination immunoassay slides. Proprietary software algorithm analyzes agglutination patterns to classify results as reactive or nonreactive; provides initial predictive titer analysis from undiluted serum or determines endpoint titer from serial diluted specimens. Used in clinical laboratory settings by trained professionals. Output includes standardized test interpretation and titer projections, enabling storage, retrieval, and transmittal of results. Automating interpretation reduces subjectivity caused by human factors like lighting, visual acuity, and fatigue; improves consistency in titer determination compared to manual visual inspection.

Clinical Evidence

Clinical performance evaluated across 375 prospective and 3131 retrospective samples. Prospective testing showed 100% positive and 100% negative agreement with visual interpretation. Retrospective testing showed 98.4% positive and 95.5% negative agreement. Predictive titer analysis (n=1224) showed 93.6% concordance (within ±1 titer). Endpoint titer function (n=708) showed 98.9% concordance (within ±1 titer). Comparator was visual interpretation by trained laboratory professionals.

Technological Characteristics

Integrated digital particle analyzer; CCD camera sensing; light reflectance imaging; PC-based; software-driven interpretation; qualitative and semi-quantitative analysis; standalone instrument with integrated monitor/keyboard/mouse; calibration check cards provided.

Indications for Use

Indicated for healthcare professionals to objectively interpret ASI RPR Card Test for syphilis results, including standardized interpretation, predictive titer analysis, and data management. Not for blood/tissue donor screening.

Regulatory Classification

Identification

A densitometer/scanner (integrating, reflectance, thin-layer chromatography, or radiochromatogram) for clinical use is device intended to measure the concentration of a substance on the surface of a film or other support media by either a photocell measurement of the light transmission through a given area of the medium or, in the case of the radiochromatogram scanner, by measurement of the distribution of a specific radio-active element on a radiochromatogram.

Predicate Devices

• ASI RPR Card Test for syphilis (K851504)

Submission Summary (Full Text)

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510/k) Premarket Notification Submission

ASiManager-A T

Arlington Scientific. Inc.

NOV - 9 2011

#### 510(k) Summarv 5.0

#### 5.1 Preparation Date: 05-13-2011

# Submitted By

David Binks MT (ASCP), MBA Director of QA/Requlatory Affairs Arlington Scientific, Inc. 1840 North Technology Dr. Springville, UT 84663 Phone [phone] / Fax [phone]

#### 5.2 Trade Name - ASiManager-AT

Common Name - Densitometer/scanner

Classification Name (21 CFR 862.2400) Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.

#### 5.3 Predicate Device(s) - ASI RPR Card Test for Syphilis - K851504

- Device Description The ASiManager-AT is an integrated digital particle analyzer 5.4 designed to objectively interpret certain slide agglutination tests manufactured by Arlington Scientific Inc. (ASI). Qualitative and semiquantitative tests are performed by laboratory professionals who use the ASiManager-AT to provide standardized test interpretation using criteria that define reactive and nonreactive agglutination reactions. The ASiManager-AT also delivers an initial predictive titer analysis for the ASI RPR Card Test for Syphilis.
The ASiManager-AT employs a CCD (charge-coupled device) 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 ASiManager-AT further provides tools that enable the creation, storage. retrieval and transmittal of the test results.

Intended Use – The ASiManager-AT is intended to be used as an integrated digital particle analyzer to objectively interpret the ASI RPR Card Test for Syphilis. The ASiManager-AT is designed to provide standardized test interpretation, an initial predictive titer analysis, and provides for storage, retrieval, and transmittal of the test results. It is intended to be acquired, possessed and used only by health care professionals. For in vitro Diagnostic Use Only, not intended for screening blood and tissue donors.

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ASiManager-A T

- 5.5 Summary of Comparison Data - A comparison of the digital interpretation of the results of testing samples with the ASI RPR Card Test for Syphilis using the ASiManager-AT and visual interpretation by trained laboratory professionals was conducted to show substantial equivalence.
The following data are the results from three testing sites:

| | | ASiManager-AT Digital Results | |
|-------------------|-------------|-------------------------------|-------------|
| | | Reactive | Nonreactive |
| Visual<br>Results | Reactive | 3 | 0 |
| | Nonreactive | 0 | 372 |

## Combined Prospective Sample Testing - 375 Samples

These results give a percent agreement positive of 100% with reactive samples and 100% with nonreactive samples.

| Combined Retrospective Sample Testing - 3131 Sample | | | |
|-----------------------------------------------------|-------------|-------------|------|
| ASiManager-AT Digital Results | | | |
| | Reactive | Nonreactive | |
| Visual<br>Results | Reactive | 1799 | 58 |
| | Nonreactive | 29 | 1245 |

These results give a percent agreement positive of 98.4% with reactive samples and 95.5% with nonreactive samples.

Of the 1849 reactive samples from the qualitative testing 1224 were used to determine the predictive titer. The ASiManager-AT is programmed to project or predict the endpoint titer of each qualitative test by reading the undiluted serum (1:1) and determining its corresponding endpoint for reactive serums. This is done using a proprietary algorithm that interprets the reaction in the undiluted sample and projects what the endpoint titer of the sample will be. A one dilution difference is an acceptable range for equivalency because the minimal reactive endpoint titer is subject to interpretation between different observers due to many factors such as lighting, visual acuity, and fatigue, etc. Of the 1224 reactive samples tested 1146 were within the ±1 titer acceptance criteria, for a concordance of 93.6%

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### 510(k) Premarket Notification Submission

ASiManager-A T

Arlington Scientific, Inc.

Of the 1849 reactive samples from the qualitative testing 708 were used to determine the endpoint titer. The ASiManager-AT is programmed to determine the true endpoint titer of a serial diluted specimen using the RPR endpoint titer function on the instrument. The RPR endpoint titer (semiquantitative) function analyzes the entire card and indentifies in which well the serial diluted sample becomes nonreactive. The software then calculates the endpoint titer. A one dilution difference is an acceptable range for equivalency because the minimal reactive endpoint titer is subject to interpretation between different observers due to many factors such as lighting, visual acuity, and fatigue, etc. Of the 708 reactive samples tested 700 were within the ±1 titer acceptance criteria, for a concordance of 98.9%

5.6 Conclusion - The ASiManager-AT is safe and effective for its intended use.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures, with three wavy lines forming a shape reminiscent of a bird or a stylized human form.

10903 New Hampshire Avenue Silver Spring, MD 20993

Arlington Scientific, Inc. c/o Mr. David Binks Director of QA/Regulatory Affairs 1840 North Technology Drive Springville, UT 84663

NOV - 9 2011

k111356 Trade/Device Name: ASiManager-AT Regulation Number: 21CFR §862.2400 Regulation Name: Densitometer/scanner ( intergrating.reflectance, TLC, or radiochromatogram) for clinical use Regulatory Class: Class I Product Code: JQT Dated: November 7, 2011 Received: November 8, 2011

Dear Mr. Binks:

Re:

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. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a

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legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Vally attor

Sally A. Hojvat, M.Sc Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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ASiManager-A T

.. ..

Arlington Scientific, Inc.

## Indications for Use Statement

510(k) Number (if known):

Device Name: ASiManager-AT

Indications for Use:

The ASiManager-AT is intended to be used as an integrated digital particle analyzer to objectively interpret the ASI RPR Card Test for Syphilis. The ASiManager-AT is designed to provide standardized test interpretation, an initial predictive titer analysis, and provides for storage, retrieval, and transmittal of the test results. It is intended to be acquired, possessed and used only by health care professionals. For in vitro Diagnostic Use Only, not intended for screening blood and tissue donors.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Eredalee the Poole
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K/// 357