Cleared Traditional

VITAMIN B12/FOLATE DUAL RADIOASSAY KITS (K812979) - FDA 510(k) Clearance

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

K812979 · Amersham Corp. · Chemistry device
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Nov 1981
Decision
32d
Days
Class 2
Risk

K812979 is an FDA 510(k) clearance for the VITAMIN B12/FOLATE DUAL RADIOASSAY KITS. Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Amersham Corp. (Mchenry, US). The FDA issued a Cleared decision on November 24, 1981 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1295 - the FDA in vitro diagnostics and chemistry 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 Amersham Corp. devices

Submission Details

510(k) Number K812979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1981
Decision Date November 24, 1981
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGN Acid, Folic, Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1295
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 Chemistry devices follow this clearance model.

Regulatory Peers - CGN Acid, Folic, Radioimmunoassay

All 32
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K812979.
RADIAS FOLATE ENZYME IMMUNOASSAY
K933571 · Bio-Rad · Oct 1993
MILENIA FOLIC ACID
K921614 · Diagnostic Products Corp. · Jun 1992
SOLID PHASE SIMUL TRAC VITAMIN B12
K822728 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1982
QUANTA PHASE VITAMIN B-12/FOLATE RAD
K811177 · Bio-Rad · May 1981
'NO-BOIL' DUALCOUNT KIT
K810001 · Diagnostic Products Corp. · Jan 1981
125 I FOLATE SOLID PHASE RADIOASSAY
K792167 · Abbott Laboratories · Nov 1979