Cleared Traditional

K914135 - AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086

K914135 is an FDA 510(k) clearance for AMERLITE(TM) PROLACTIN-30 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 155-day FDA review.

K914135 · Amersham Corp. · Chemistry device
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Feb 1992
Decision
155d
Days
Class 1
Risk

K914135 is an FDA 510(k) clearance for the AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086. 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 February 18, 1992 after a review of 155 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Amersham Corp. devices

FDA 510(k) Submission Details - K914135

510(k) Number K914135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1991
Decision Date February 18, 1992
Days to Decision 155 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 88d · This submission: 155d
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 K914135.
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