Cleared Traditional

K780355 - ATROXIN (FDA 510(k) Clearance)

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

K780355 · Sigma Chemical Co. · Hematology device
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Apr 1978
Decision
46d
Days
Class 2
Risk

K780355 is an FDA 510(k) clearance for the ATROXIN. Classified as Bothrops Atrox Reagent (product code JCO), Class II - Special Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1978 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8100 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K780355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1978
Decision Date April 18, 1978
Days to Decision 46 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 113d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JCO Bothrops Atrox Reagent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8100
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.