Cleared Traditional

K883878 - AMERLITE PROLACTIN ASSAY

K883878 is an FDA 510(k) clearance for AMERLITE PROLACTIN ASSAY, manufactured by Amersham Corp.. The device is a Class 1 Chemistry device with product code CFT cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K883878 · Amersham Corp. · Chemistry device
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Nov 1988
Decision
49d
Days
Class 1
Risk

K883878 is an FDA 510(k) clearance for the AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144). Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on November 1, 1988 after a review of 49 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 Amersham Corp. devices

FDA 510(k) Submission Details - K883878

510(k) Number K883878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1988
Decision Date November 01, 1988
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
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 52
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K883878.
CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY
K894988 · Ciba Corning Diagnostics Corp. · Oct 1989
MILENIA(TM) PROLACTIN (MKPR1,5)
K895003 · Diagnostic Products Corp. · Sep 1989
IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES
K883747 · Diagnostic Products Corp. · Nov 1988
PRL-QUANT
K883269 · Leeco Diagnostics, Inc. · Sep 1988
PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM
K881774 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1988
BINAX PROLACTIN IRMA DIAGNOSTIC KIT
K880218 · Binax, Inc. · Mar 1988