Cleared Traditional

K013397 - PACIFIC HEMOSTASIS REFERENCE EMULSION

K013397 is the FDA 510(k) clearance for PACIFIC HEMOSTASIS REFERENCE EMULSION by Fisher Diagnostics. It is a Class 2 Hematology device (product code JIX) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K013397 · Fisher Diagnostics · Hematology device
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Feb 2002
Decision
123d
Days
Class 2
Risk

K013397 is an FDA 510(k) clearance for the PACIFIC HEMOSTASIS REFERENCE EMULSION. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Fisher Diagnostics (Middletown, US). The FDA issued a Cleared decision on February 15, 2002 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1150 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K013397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2001
Decision Date February 15, 2002
Days to Decision 123 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 113d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 202
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K013397.
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K012250 · Hemagen Diagnostics, Inc. · Sep 2001