AIACT KIT

K032952 · Sienco, Inc. · JBP · Dec 12, 2003 · Hematology

Device Facts

• Record ID: K032952
• Device Name: AIACT KIT
• Applicant: Sienco, Inc.
• Product Code: JBP · Hematology
• Decision Date: Dec 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7140
• Device Class: Class 2

Intended Use

The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood. The aiACT Kit is intended only for high dose heparin anticoagulation management (ACT ≥400 seconds on Sonoclot Analyzer) as typical encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin.

Device Story

aiACT Kit is an in vitro diagnostic test used with the Sonoclot Coagulation & Platelet Function Analyzer. It utilizes a cuvette containing a blend of celite and clay for contact activation of whole blood samples. The system measures the clot signal over time to provide quantitative Onset/ACT and Clot Rate results. Used primarily in clinical settings during cardiopulmonary bypass surgery for high-dose heparin anticoagulation management. The device is operated by healthcare professionals. Results are displayed on the Sonoclot Analyzer, allowing clinicians to monitor coagulation status in the presence of aprotinin, which does not affect the test results. This aids in managing anticoagulation levels during surgery, potentially improving patient safety by ensuring appropriate heparin dosing.

Clinical Evidence

Bench testing only. Performance comparison provided between aiACT and standard SonACT kits using native whole blood from a normal population. Normal ranges established for ACT/Onset (62-93 seconds) and Clot Rate (22-41 Clot Signal Units/minute) for aiACT. No clinical prospective or retrospective studies were required for this 510(k) submission.

Technological Characteristics

Cuvette-based test system; plastic lidded cuvette containing celite and clay contact activator and magnetic stir bar. Operates with Sonoclot Coagulation & Platelet Function Analyzer. Provides quantitative Onset/ACT and Clot Rate. Designed for high-dose heparin management; unaffected by aprotinin.

Indications for Use

Indicated for high-dose heparin anticoagulation management in patients undergoing cardiopulmonary bypass surgery where aprotinin is administered. Suitable for use with native or citrated whole blood.

Regulatory Classification

Identification

An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.

Predicate Devices

• SonACT Kit (K952560)

Submission Summary (Full Text)

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Sienco. Inc. 11485-A West 48th Avenue Wheat Ridge, CO 80033 USA 800/432-1624 303/420-1148 303/420-2204(Fax) http://www.sienco.com email:[e-mail]

## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K032952

- (1) Contact Person: Barbara DeBiase, Director, Sienco Inc. Summary Preparation Date: 26 November, 2003
- (2) Device Trade Name: aiACT Kit Common Name: Activated Clotting Time (ACT) Test Classification Name: Activated Whole Blood Clotting Time Test Classification: Class II, 21 CFR 864.7174
- (3)Identification of predicate device to which substantial equivalence is being claimed: SonACT Kit, included in 510(k) # K952560

## (4) and (5) Device Description and Intended Use:

The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood.

The aiACT Kit is intended only for high dose heparin anticoagulation management (ACT ≥ 400 seconds on Sonoclot Analyzer) as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment.

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## (6) Technological Characteristic Comparison of the aiACT+ Kit to the standard
SonACT Kit:

| ITEM | aiACT | STANDARD SONACT |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name | Activated Whole Blood Clotting<br>Time Test | Activated Whole Blood Clotting<br>Time Test |
| IVD Reagent for<br>Use With | Sonoclot Coagulation & Platelet<br>Function Analyzer | Sonoclot Coagulation & Platelet<br>Function Analyzer |
| Intended Use | High dose heparin anticoagulation<br>management , especially in the<br>presence of aprotinin | General purpose global hemostasis<br>monitoring, hypercoagulable and<br>hyperfibrinolysis screening,<br>platelet function assessment,<br>anticoagulation management (low<br>to high heparin levels) |
| Results Provided | Quantitative results for Activated<br>Clotting Time (Sonoclot Onset<br>Time) and rate of fibrin<br>polymerization (Sonoclot Clot<br>Rate). | Quantitative results for Activated<br>Clotting Time (Sonoclot Onset<br>Time) and rate of fibrin<br>polymerization (Sonoclot Clot<br>Rate). Qualitative and quantitative<br>platelet function information (time<br>to peak, clot retraction). |
| Test Design | Yellow plastic lidded cuvette<br>containing contact activator and<br>magnetic stir bar | Colorless plastic lidded cuvette<br>containing contact activator and<br>magnetic stir bar |
| Kit Contents | Cuvettes, probes and instructions<br>for use | Cuvettes, probes and instructions<br>for use |
| Quality Control | Reference plasma quality control | Reference plasma quality control |

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- (7) Performance Comparison of the aiACT Kit to the standard SonACT Kits Expected Performance Comparison of the arrow of the arrow to the provided in the tables below.

| aiACT Test (#800-0442, #800-0441)<br>Native Whole Blood - Normal Population, No Heparin | |
|-----------------------------------------------------------------------------------------|----------------------------------|
| Result | Normal Range |
| ACT/Onset | 62-93 seconds |
| Clot RATE | 22-41 Clot Signal Units / minute |

| Standard SonACT Test (#800-0435, #800-0434)<br>Native Whole Blood - Normal Population, No | |
|-------------------------------------------------------------------------------------------|----------------------------------|
| Result | Normal Range |
| ACT/Onset | 85-145 seconds |
| Clot RATE | 15-45 Clot Signal Units / minute |
| Time to Peak | < 30 minutes |

Normal, aiACT Test, Native Whole

Image /page/2/Figure/4 description: This image shows a graph of clot signal versus time in minutes. The graph shows an upward sloping curve, indicating that the clot signal increases over time. The onset L/ACT is 82, and the clot rate is 2.4. The x-axis represents time in minutes, ranging from 0 to 20, while the y-axis represents the clot signal, ranging from 0 to 120.

Normal, SonACT Test, Native Whole Blood

| 12<br>S-190-<br>రా<br>15<br>-<br>Close arman<br>1<br>t<br>11<br>3<br>6<br>- | . .<br>1<br>. | -<br>1<br>4 | -<br><br>-<br>€<br>-<br>4 | -<br>œ<br>-<br>. +<br>. .<br>- | -<br>-<br>-<br>3<br>1 | -<br>-<br>1<br>-<br>-<br>-<br>-<br>-<br>-<br>3<br>:<br>-<br>. .<br>!<br>-<br>V<br>1<br>r B<br>-<br>-<br>-<br><br>-<br>4<br>-<br><br>-<br>=<br>- | =<br>-<br>1<br><br>:<br>-<br>-<br>-<br>. .<br>= | -<br>100 000 000<br>:<br>-<br>-<br><br><br>- ··<br>:<br>:<br>1<br><br>-<br>-<br>1<br>14<br>. . | 17<br>- 117-<br>1<br>:<br>ದ್ರತ<br>. .<br>--<br><br><br><br><br>---<br>1<br>STS ----<br>1 10 100<br>.<br>-<br>સ્ત | ﺮ<br>=<br>1<br><br>-<br>4<br>-<br>-<br>=<br>6<br>4<br>1<br>-<br>4 |
|-----------------------------------------------------------------------------|---------------|-------------|---------------------------|--------------------------------|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| | if<br>1 | : | ੂੰ | <br>4 | | <br><br><br> | | :<br>. .<br><br>:<br>= | 5200 ICC.<br>ﻟﻬﺎ ﻓﻬﻮ ﺍ<br>- | ***** |

Onset/ACT: 89
22 Clot RATE: Time to Peak; 17.5

Jon H. Hardman, President Nov 29, 2003

Jon Henderson, President

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEC 1 2 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Barbara DeBiase Director Sienco. Inc. 11485-A West 48th Avenue Wheat Ridge, Colorado 80033

Re: k032952

Trade/Device Name: aiACT Kit Regulation Number: 21 CFR § 864.7140 Regulation Name: Activated Whole Blood Clotting Time Test Regulatory Class: II Product Code: JBP Dated: September 16, 2003 Received: September 22, 2003

Dear Ms. DeBiase:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR). Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K032952 510(k) Number (if known):

aiACT Kit Device Name:_

Indications For Use:

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uses a blend of celite and clay for contact activation. It may also be used with citrated blood.

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Seconds on Sonoclot Analyzer) as typically encountered by announin when used seconds on Sonoclot Analyzes as lyncation of extentially unaffected by protition. When used The aiACT test provides ACT test provides quantitative Oneet/ACT and Clot Rate
with the Sonoclot Analyzes System, the siACT test provides quantitative OneerACT and Clot Rate with the Sonociol Analyzel System, the arrest for platelet function assessment.

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

Division/Sign/Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032952

Prescription Use \$\checkmark\$

(Optional Format 3-10-98)