(191 days)
Not Found
No
The summary describes a standard in-vitro diagnostic kit for coagulation testing and does not mention any AI or ML components. The performance studies compare the new kit to a predicate device using traditional metrics.
No.
The device is an in-vitro diagnostic product used for monitoring hemostasis and is not intended for treating or alleviating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "gbACT+ Kit is an in-vitro diagnostic product." It also details its use for "global hemostasis monitoring" and screening for various conditions, which are diagnostic purposes.
No
The device description explicitly states that the kit contains physical components (glass bead cuvettes, probes, instructions for use, magnetic stir bar) and is an in-vitro diagnostic product designed for use with a separate hardware system (Sonoclot Coagulation & Platelet Function Analyzer System). This indicates it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The description explicitly states "The gbACT+ Kit is an in-vitro diagnostic product..." and details its use for "general purpose global hemostasis monitoring" using blood samples.
- Device Description: It describes a kit containing components (cuvettes, probes) designed for use with an analyzer system to perform a diagnostic test on biological samples (whole blood or plasma).
- Performance Studies: The document includes a section on "Performance Comparison" and provides "Typical Results and Examples," which are characteristic of documentation for diagnostic devices.
- Key Metrics: It lists "Quantitative results" and "Qualitative and quantitative information" related to the test, indicating it provides diagnostic data.
- Predicate Device(s): The mention of a "Predicate Device(s)" with a K number (K952560) is a strong indicator that this device is being submitted for regulatory clearance as a diagnostic device, often compared to a previously cleared predicate.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The gbACT+ Kit is an in-vitro diagnostic product designed for use with the Sonoclot Coagulation & Platelet Function Analyzer System. The gbACT+ test is an activated whole blood clotting time test. It may also be used with citrated whole blood or plasma. The gbACT+ Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management at low to moderate heparin levels (1 to 2 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening.
Product codes (comma separated list FDA assigned to the subject device)
JBP
Device Description
The gbACT+ Kit is an in-vitro diagnostic product designed for use with the Sonoclot Coagulation & Platelet Function Analyzer System. Each kit contains glass bead cuvettes, probes and instructions for use. Current package sizes of 100 (#800-0412) and 24 (#800-0411) tests are available. The lidded pink cuvettes contain a controlled amount of the glass bead activator and a magnetic stir bar. A mason box is used for the kit package.
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)
Performance Comparison of the gbACT+ Kit to the standard SonACT Kitt Expected values for the gbACT+ Kit and the standard SonACT to estandard values for the gDACT+ Tric and the standard Somro-Print as pro-SonACT test are also included.
gbACT+ Typical Results and Examples
Native Whole Blood - Normal Population, No Heparin
Result: ACT/Onset, Normal Range: 125 - 220 seconds
Result: Clot RATE, Normal Range: 10-45 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
MAY 28 1000 Sienco, Inc. 4892 Van Gordon St. - Unit 203 Wheat Ridge, CO USA 80033 303/420-2204(Fax) 303/420-1148 800/432-1624
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: _K 984 141
- (1) Contact Person: Barbara DeBiase, Director, Sienco Inc. Summary Preparation Date: 1 November 1998
- (2) Device Trade Name: gbACT+ Kit Common Name: Activated Clotting Time (ACT) Test Classification Name: Activate Whole Blood Clotting Time Test Classification: Class II, 21 CFR 864.7140
- (3) Identification of predicate device to which substantial equivalence is being claimed: SonACT Kit, 510(k) # K952560
- (4) and (5) Device Description and Intended Use: The gbACT+ Kit is an in-vitro diagnostic product designed for use with the Sonoclot Coagulation & Platelet Function Analyzer System. Each kit contains glass bead cuvettes, probes and instructions for use. Current package sizes of 100 (#800-0412) and 24 (#800-0411) tests are available. The lidded pink cuvettes contain a controlled amount of the glass bead activator and a magnetic stir bar. A mason box is used for the kit package.
The gbACT+ test is an activated whole blood clotting time test. It may also be used with citrated whole blood or plasma. The gbACT+ Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management at low to moderate heparin levels (1 to 2 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening.
. "
1
(6) Technological Characteristic Comparison of the gbACT+ Kit to the standard SonACT Kit:
| ITEM | gbACT+ | 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 | General purpose global hemostasis | |
| monitoring, hypercoagulable and | ||
| hyperfibrinolysis screening, | ||
| platelet function assessment, | ||
| anticoagulation management (low | ||
| to moderate heparin levels) | 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 (Onset /ACT Time). | ||
| Qualitative and quantitative fibrin | ||
| formation information (Clot RATE, | ||
| Sonoclot Signature). Qualitative | ||
| and quantitative platelet function | ||
| information from Sonoclot | ||
| Signature. Qualitative and | ||
| quantitative hyperfibrinolysis | ||
| information from Sonoclot | ||
| Signature. | Quantitative results for Activated | |
| Clotting Time (Onset/ACT Time). | ||
| Qualitative and quantitative fibrin | ||
| formation information (Clot RATE | ||
| Sonoclot Signature). Qualitative | ||
| and quantitative platelet function | ||
| information from Sonoclot | ||
| Signature. Qualitative and | ||
| quantitative hyperfibrinolysis | ||
| information from Sonoclot | ||
| Signature. | ||
| Test Design | Pink plastic lidded cuvette | |
| containing contact activator (glass | ||
| beads ) and magnetic stir bar | Colorless plastic lidded cuvette | |
| containing contact activator (celite) | ||
| and magnetic stir bar | ||
| Kit Contents | Cuvettes, probes and instructions | |
| for use | Cuvettes, probes and instructions | |
| for use | ||
| Quality Control | Reference Plasma Quality Control | |
| Kit, Sienco part #900-1318 | Reference Plasma Quality Control | |
| Kit, Sienco part #900-1318 |
510(k) Summary - Page 2 of 3
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- (7) Performance Comparison of the gbACT+ Kit to the standard SonACT Kitt Expected
Performance Comparison of the goACT The to the standard SonACT in the lables below.
values for the gbACT+ Kit and the standard SonACT to estandard values for the gDACT+ Tric and the standard Somro-Print as pro-SonACT test are also included.
gbACT+ Typical Results and Examples
| gbACT+ Test (#800-0411, 800-0412)
| Native Whole Blood - Normal Population, No Heparin | |
|---|---|
| Result | Normal Range |
| ACT/Onset | 125 - 220 seconds |
| Clot RATE | 10-45 Clot Signal Units / minute |
| Time to Peak | |
| ----------------------------------------- | -------------------------------------------- |
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K984141 |
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | _________________ |
|---|---|
| (Optional Format 1-2-96) |