Cleared Traditional

K831345 - RIANEN PROLACTIN 125I KIT

K831345 is an FDA 510(k) clearance for RIANEN PROLACTIN 125I KIT, manufactured by New England Nuclear. The device is a Class 1 Chemistry device with product code CFT cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K831345 · New England Nuclear · Chemistry device
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Jun 1983
Decision
44d
Days
Class 1
Risk

K831345 is an FDA 510(k) clearance for the RIANEN PROLACTIN 125I KIT. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by New England Nuclear (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1625 - 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 New England Nuclear devices

FDA 510(k) Submission Details - K831345

510(k) Number K831345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1983
Decision Date June 08, 1983
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 88d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

CFT Device Classification - Class 1, General Controls

Product Code CFT Radioimmunoassay, Prolactin (lactogen)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1625
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.

Regulatory Peers - CFT Radioimmunoassay, Prolactin (lactogen)

All 65
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K831345.
TANDEM - EPRL
K843804 · Hybritech, Inc. · Nov 1984
PROLACTIN RIABEAD PROLACTIN RADIOIMM
K841118 · Abbott Laboratories · May 1984
COAT-A-COUNT NHS-PROLACTIN KIT AND
K833925 · Diagnostic Products Corp. · Jan 1984
RADIOIMMUNOASSAY TEST SYSTEM PRL
K830412 · Monobind · Apr 1983
ABBOTT LABORATORIES PROLACTIN EIA
K822759 · Abbott Laboratories · Oct 1982
TANDEM PROLACTIN KIT
K821545 · Hybritech, Inc. · Jun 1982