(81 days)
Not Found
No
The document describes a standard in vitro diagnostic test kit and its performance characteristics, with no mention of AI or ML technologies.
No.
The device is described as an "in vitro diagnostic test" intended for "high dose heparin anticoagulation management" and provides "ACT results". It is used with an analyzer system to provide information about blood clotting time, which is a diagnostic function, not a therapeutic intervention.
Yes
The device is explicitly described as "an in vitro diagnostic test" for managing high dose heparin anticoagulation during cardiopulmonary bypass surgery. It measures activated whole blood clotting time to provide quantitative Onset/ACT and Clot Rate results, which are all diagnostic indicators.
No
The device description explicitly states the aiACT Kit is a "yellow plastic lidded cuvette containing contact activator and magnetic stir bar," indicating it is a physical component, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated in the Intended Use and Device Description: Both sections clearly state that the aiACT Kit is an "in vitro diagnostic test".
- Measures a physiological parameter in vitro: The device measures the activated whole blood clotting time (ACT) using a blood sample outside of the body ("in vitro").
- Used for medical purposes: The test is intended for "high dose heparin anticoagulation management" during cardiopulmonary bypass surgery, which is a medical application.
- Provides quantitative results: The test provides "quantitative Onset/ACT and Clot Rate results," which are used for diagnostic or monitoring purposes.
The information provided strongly indicates that the aiACT Kit meets the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
JBP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Normal Range for aiACT Test (#800-0442, #800-0441) Native Whole Blood - Normal Population, No Heparin:
Result: ACT/Onset, Normal Range: 62-93 seconds
Result: Clot RATE, Normal Range: 22-41 Clot Signal Units / minute
Normal Range for Standard SonACT Test (#800-0435, #800-0434) Native Whole Blood - Normal Population, No Heparin:
Result: ACT/Onset, Normal Range: 85-145 seconds
Result: Clot RATE, Normal Range: 15-45 Clot Signal Units / minute
Result: Time to Peak, Normal Range:
§ 864.7140 Activated whole blood clotting time tests.
(a)
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.(b)
Classification. Class II (performance standards).
0
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:sienco@sienco.com
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.
1
(6) Technological Characteristic Comparison of the aiACT+ Kit to the standard
SonACT Kit:
| ITEM | aiACT | STANDARD SONACT |
|---|---|---|
| Classification Name | Activated Whole Blood Clotting | |
| Time Test | Activated Whole Blood Clotting | |
| Time Test | ||
| IVD Reagent for | ||
| Use With | Sonoclot Coagulation & Platelet | |
| Function Analyzer | Sonoclot Coagulation & Platelet | |
| Function Analyzer | ||
| Intended Use | High dose heparin anticoagulation | |
| management , especially in the | ||
| presence of aprotinin | General purpose global hemostasis | |
| monitoring, hypercoagulable and | ||
| hyperfibrinolysis screening, | ||
| platelet function assessment, | ||
| anticoagulation management (low | ||
| to high heparin levels) | ||
| Results Provided | Quantitative results for Activated | |
| Clotting Time (Sonoclot Onset | ||
| Time) and rate of fibrin | ||
| polymerization (Sonoclot Clot | ||
| Rate). | Quantitative results for Activated | |
| Clotting Time (Sonoclot Onset | ||
| Time) and rate of fibrin | ||
| polymerization (Sonoclot Clot | ||
| Rate). Qualitative and quantitative | ||
| platelet function information (time | ||
| to peak, clot retraction). | ||
| Test Design | Yellow plastic lidded cuvette | |
| containing contact activator and | ||
| magnetic stir bar | Colorless plastic lidded cuvette | |
| containing contact activator and | ||
| magnetic stir bar | ||
| Kit Contents | Cuvettes, probes and instructions | |
| for use | Cuvettes, probes and instructions | |
| for use | ||
| Quality Control | Reference plasma quality control | Reference plasma quality control |
2
- (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)
| 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)
| 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 |