Cleared Traditional

K782157 - IRMA TEST

K782157 is the FDA 510(k) clearance for IRMA TEST by Nordiclab Intl.. It is a Class 2 Microbiology device (product code JMG) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K782157 · Nordiclab Intl. · Microbiology device
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Jan 1979
Decision
26d
Days
Class 2
Risk

K782157 is an FDA 510(k) clearance for the IRMA TEST, NORDICLAB FERRITIN. Classified as Radioimmunoassay (two-site Solid Phase), Ferritin (product code JMG), Class II - Special Controls.

Submitted by Nordiclab Intl. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1979 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5340 - the FDA microbiology 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 Nordiclab Intl. devices

Submission Details

510(k) Number K782157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1978
Decision Date January 17, 1979
Days to Decision 26 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 102d · This submission: 26d
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 Microbiology devices follow this clearance model.

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

All 18
Devices cleared under the same product code (JMG) and FDA review panel - the closest regulatory comparables to K782157.
QUANTIMUNE FERRITIN IRMA
K810799 · Bio-Rad · Apr 1981
TERRITIN RIA KIT
K792588 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1980
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