Pacific Hemostasis Reference Emulsion
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K013397 FDA 510(k)
- FDA Product Code
- JIX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1150 FDA 510(k)
- Regulation Number
- 862.1150 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Pacific Hemostasis Reference Emulsion is a calibrator, multi-analyte mixture used as a reagent for in vitro coagulation studies. It functions as a standardized reference material for laboratory coagulation testing and assists in assessing patient coagulation status.
The device is intended to be used as a priming solution on Instrumentation Laboratory ACLTM coagulation analyzers. It is operated by laboratory technicians in clinical settings, with output used to calibrate or verify analyzer performance. The device received FDA 510(k) clearance (K013397) as a Class 2 hematology device with product code JIX through the traditional pathway.
Frequently asked questions
What is Pacific Hemostasis Reference Emulsion used for?
It is used as a calibrator and multi-analyte mixture reagent for in vitro coagulation studies, serving as a standardized reference material to assess patient coagulation status and verify analyzer performance on Instrumentation Laboratory ACLTM systems.
How is Pacific Hemostasis Reference Emulsion supplied and used?
It is supplied as a priming solution intended for use by laboratory technicians in clinical settings to calibrate or verify the performance of Instrumentation Laboratory ACLTM coagulation analyzers.
Is Pacific Hemostasis Reference Emulsion sterile or single-use?
The device data does not specify sterility or single-use status; it is described as a calibrator reagent for laboratory use, so users should consult the manufacturer's labeling for handling and usage instructions.
What regulatory pathway was used for Pacific Hemostasis Reference Emulsion?
It received FDA 510(k) clearance (K013397) through the traditional pathway as a Class 2 hematology device with product code JIX, based on a determination of substantial equivalence.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K013397 FDA 510 (k) - PACIFIC HEMOSTASIS REFERENCE EMULSION, PACIFIC HEMOSTASIS REFERENCE EMULSION (K013397) — FDA 510(k ..., Pacific Hemostasis Reference Emulsion 100240
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K013397 | Class II | Active |
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Manufacturer
- Manufacturer
- Fisher Diagnostics
Sources (1)
- FDA 510(k) K013397 24 fields · synced Sep 22, 2026