Cleared Traditional

PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM (K881774) - FDA 510(k) Clearance

Class I Chemistry device.

K881774 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Jun 1988
Decision
43d
Days
Class 1
Risk

K881774 is an FDA 510(k) clearance for the PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on June 8, 1988 after a review of 43 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K881774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1988
Decision Date June 08, 1988
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 22
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K881774.
ABBOTT IMX PROLACTIN
K896162 · Abbott Laboratories · Jan 1990
MILENIA(TM) PROLACTIN (MKPR1,5)
K895003 · Diagnostic Products Corp. · Sep 1989
IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES
K883747 · Diagnostic Products Corp. · Nov 1988
BECKMAN EPSILON(TM) PROLACTIN TEST KIT
K864439 · Beckman Instruments, Inc. · Jan 1987
PROLACTIN RIABEAD II DIAGNOSTIC KIT
K863240 · Abbott Laboratories · Sep 1986
TERUMO SENSIBEAD EIA HPRL KIT
K854768 · Terumo Medical Corp. · Jan 1986