Cleared Traditional

ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A (K071255) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K071255 · Hyphen Biomed · Hematology device
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Sep 2007
Decision
126d
Days
Class 2
Risk

K071255 is an FDA 510(k) clearance for the ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A. Classified as Platelet Factor 4 Radioimmunoassay (product code LCO), Class II - Special Controls.

Submitted by Hyphen Biomed (Mason, US). The FDA issued a Cleared decision on September 7, 2007 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7695 - 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.

View all Hyphen Biomed devices

Submission Details

510(k) Number K071255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2007
Decision Date September 07, 2007
Days to Decision 126 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 113d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCO Platelet Factor 4 Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7695
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 - LCO Platelet Factor 4 Radioimmunoassay

All 12
Devices cleared under the same product code (LCO) and FDA review panel - the closest regulatory comparables to K071255.
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HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
K170854 · Instrumentation Laboratory CO · Sep 2017
HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls
K153137 · Instrumentation Laboratory CO · Jul 2016