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510(k) Data Aggregation
(191 days)
GBACT + KIT
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.
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 provided text describes the gbACT+ Kit and claims substantial equivalence to the predicate device, the SonACT Kit. However, it does not include detailed "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the way typically expected for a modern medical device submission with specific performance metrics and statistical analysis.
Instead, the submission primarily focuses on technological characteristic comparison and typical results for both the new device (gbACT+) and the predicate device (SonACT). The implicit acceptance criteria seems to be that the gbACT+ Kit produces "normal ranges" of results that are comparable or acceptable within the context of activated whole blood clotting time tests, and that its performance characteristics are similar to the predicate device.
Here's an attempt to extract and present the information based on the provided text, acknowledging its limitations regarding explicit acceptance criteria and detailed study methodology:
1. Table of acceptance criteria and the reported device performance
Since explicit "acceptance criteria" (e.g., "sensitivity must be >X%, specificity >Y%") are not provided, I'll infer them from the "Normal Range" values presented for both devices and their intended use. The performance reported for the gbACT+ is its "Normal Range" in comparison to the predicate.
| Performance Metric | Acceptance Criteria (Inferred from Predicate's Normal Range and Intended Use) | Reported Device Performance (gbACT+ Normal Range) |
|---|---|---|
| ACT/Onset (Native Whole Blood - Normal Population, No Heparin) | Produce an ACT/Onset within a clinically acceptable range for activated whole blood clotting time, comparable to or improving upon the predicate. Predicate range: 85-145 seconds. | 125 - 220 seconds |
| Clot RATE (Native Whole Blood - Normal Population, No Heparin) | Produce a Clot RATE within a clinically acceptable range. Predicate range: 15-45 Clot Signal Units / minute. | 10-45 Clot Signal Units / minute |
| Time to Peak (Native Whole Blood - Normal Population, No Heparin) | Produce a Time to Peak within a clinically acceptable range. Predicate range: |
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