Cleared Traditional

K854768 - TERUMO SENSIBEAD EIA HPRL KIT

K854768 is an FDA 510(k) clearance for TERUMO SENSIBEAD EIA HPRL KIT, manufactured by Terumo Medical Corp.. The device is a Class 1 Chemistry device with product code CFT cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K854768 · Terumo Medical Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1986
Decision
47d
Days
Class 1
Risk

K854768 is an FDA 510(k) clearance for the TERUMO SENSIBEAD EIA HPRL KIT. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on January 13, 1986 after a review of 47 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K854768

510(k) Number K854768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1985
Decision Date January 13, 1986
Days to Decision 47 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
41d faster than avg
Panel avg: 88d · This submission: 47d
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 57
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K854768.
LEE-BEAD PROLACTIN (EIA)
K861945 · Leeco Diagnostics, Inc. · Jun 1986
ENCORE PROLACTIN REAGENT
K860221 · Hybritech, Inc. · Mar 1986
ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM
K854805 · Nichols Institute Diagnostics · Jan 1986
PRL QUIK RIA KIT
K850383 · Pacific Biotech, Inc. · Mar 1985
TANDEM - EPRL
K843804 · Hybritech, Inc. · Nov 1984
PROLACTIN RIABEAD PROLACTIN RADIOIMM
K841118 · Abbott Laboratories · May 1984