Coacute Antithrombin Chromogenic Assay
510(k) K902393
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK902393 | Date25 Sep 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JBQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7060
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Coacute Antithrombin Chromogenic Assay is an in vitro diagnostic device classified as an Antithrombin III Quantitation assay. It measures plasma antithrombin III levels using chromogenic substrate technology, enabling quantitative assessment of this anticoagulant protein. Antithrombin III plays a critical role in regulating blood coagulation by inhibiting activated clotting factors, and its deficiency is associated with thrombotic disorders. This assay provides objective results to support clinical management of conditions linked to antithrombin deficiency.
This assay is supplied as a single-use reagent kit for laboratory use, requiring no special storage conditions beyond refrigeration. It is intended for use in hematology laboratories and is not MRI-compatible. The device is authorized under FDA 510(k) clearance (K902393) and falls under Class II regulatory classification (JBQ). No additional sterilization or reprocessing is required, as it is designed for one-time use per test. Compliance with 21 CFR 864.7060 applies, ensuring adherence to in vitro diagnostic device standards.
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Questions
AI-generated answers, 1 Oct 2026
What clinical conditions does the Coacute Antithrombin Chromogenic Assay help evaluate?
This assay quantifies plasma antithrombin III levels, a key anticoagulant protein that inhibits activated clotting factors. Low levels are linked to thrombotic disorders, so the test supports clinical decision-making for conditions like hereditary antithrombin deficiency or acquired deficiencies (e.g., from liver disease or severe infections). By providing objective measurements, it aids in risk stratification and treatment planning for patients at risk of venous thromboembolism.
How is the Coacute Antithrombin Chromogenic Assay supplied, and what storage requirements apply?
The assay is supplied as a single-use reagent kit designed for laboratory use. No additional sterilization or reprocessing is required, as it is intended for one-time use per test. Standard refrigeration (2–8°C) is the only specified storage condition, ensuring stability without specialized handling. Always check the packaging label for expiration dates before use.
Is this device reusable, or is it intended for single-use only?
The Coacute Antithrombin Chromogenic Assay is explicitly designed for single-use per test. It is a reagent kit with no components intended for reuse or reprocessing, which aligns with its classification as an in vitro diagnostic device under 21 CFR 864.7060. Reusing the kit could compromise accuracy and patient safety, so each kit must be discarded after completion of the assay.
What regulatory pathway does this assay follow, and which advisory committee oversees its classification?
The Coacute Antithrombin Chromogenic Assay was cleared via the FDA 510(k) pathway under Traditional review (K-number: K902393) and is classified as Class II. Its regulatory classification falls under the Hematology specialty, with oversight by the Hematology (HE) Advisory Committee. The device is also compliant with 21 CFR 864.7060, which governs in vitro diagnostic assays for quantitation purposes.
Can this assay be used outside a hematology laboratory, or are there specific facility requirements?
The Coacute Antithrombin Chromogenic Assay is intended exclusively for use in hematology laboratories. While it does not require specialized infrastructure beyond standard laboratory equipment (e.g., spectrophotometer for chromogenic substrate analysis), its clinical application—quantifying antithrombin III—is most relevant in settings where coagulation disorders are diagnosed and managed. Facilities lacking hematology expertise or proper workflows for anticoagulant assays should not use this device.