Cleared Traditional

K792588 - TERRITIN RIA KIT

K792588 is the FDA 510(k) clearance for TERRITIN RIA KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Immunology device (product code JMG) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K792588 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Immunology device
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Jan 1980
Decision
25d
Days
Class 2
Risk

K792588 is an FDA 510(k) clearance for the TERRITIN RIA KIT. Classified as Radioimmunoassay (two-site Solid Phase), Ferritin (product code JMG), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on January 11, 1980 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5340 - 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 K792588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1979
Decision Date January 11, 1980
Days to Decision 25 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 104d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JMG Radioimmunoassay (two-site Solid Phase), Ferritin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
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 Immunology devices follow this clearance model.

Regulatory Peers - JMG Radioimmunoassay (two-site Solid Phase), Ferritin

All 17
Devices cleared under the same product code (JMG) and FDA review panel - the closest regulatory comparables to K792588.
DELFIA(TM) FERRITIN KIT
K872955 · Lkb Instruments, Inc. · Aug 1987
CORNINGS MAGIC FERRITIN RADIOIMMUNO-
K840460 · Corning Medical & Scientific · Mar 1984
QUANTIMUNE FERRITIN IRMA
K810799 · Bio-Rad · Apr 1981
RADIOIMMUNOASSAY TEST SYSTEM
K791096 · Corning Medical & Scientific · Aug 1979
RIA KIT, FERRITIN SOLID PHASE
K781946 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1979
RIA SYSTEM FOR HUMAN FE-RITIN
K781527 · Calbiochem-Behring Corp. · Oct 1978