Cleared Traditional

K760881 - FEBRILE ANTIGEN CONTROL SERA (FDA 510(k) Clearance)

Class I Immunology device.

K760881 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Immunology device
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Nov 1976
Decision
19d
Days
Class 1
Risk

K760881 is an FDA 510(k) clearance for the FEBRILE ANTIGEN CONTROL SERA. Classified as Antigens, Febrile (weil-felix), All Groups (product code GSZ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on November 9, 1976 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3410 - the FDA immunology 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.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K760881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1976
Decision Date November 09, 1976
Days to Decision 19 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 104d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GSZ Antigens, Febrile (weil-felix), All Groups
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3410
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.