Cleared Abbreviated

BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA (K043451) - FDA 510(k) Clearance

Also marketed or referenced as:
BIOPHEN PLASMA CALIBRATOR

Class II Hematology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K043451 · Hyphen Biomed · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
93d
Days
Class 2
Risk

K043451 is an FDA 510(k) clearance for the BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Hyphen Biomed (Mason, US). The FDA issued a Cleared decision on March 17, 2005 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Hyphen Biomed devices

Submission Details

510(k) Number K043451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2004
Decision Date March 17, 2005
Days to Decision 93 days
Submission Type Abbreviated
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 113d · This submission: 93d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - GGN Plasma, Coagulation Control

All 98
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K043451.
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