Cleared Traditional

AMERLITE PROLACTIN-30 ASSAY (K922170) - FDA 510(k) Clearance

Class I Chemistry device.

K922170 · Eastman Kodak Company · Chemistry device
Download Printable Device Report (PDF)
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Sep 1992
Decision
117d
Days
Class 1
Risk

K922170 is an FDA 510(k) clearance for the AMERLITE PROLACTIN-30 ASSAY. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on September 2, 1992 after a review of 117 days - within the typical 510(k) review window.

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 Eastman Kodak Company devices

Submission Details

510(k) Number K922170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1992
Decision Date September 02, 1992
Days to Decision 117 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 88d · This submission: 117d
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 21
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K922170.
COBAS CORE PROLACTIN EIA
K930305 · Roche Diagnostic Systems, Inc. · Aug 1993
VISTA PROLACTIN ASSAY
K926386 · Syva Co. · Mar 1993
IMMULITE PROLACTIN
K925846 · Diagnostic Products Corp. · Mar 1993
AFFINITY PROLACTIN TEST SYSTEM
K902698 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1990
PROLACTIN (LACTOGEN) TEST SYSTEM
K901673 · Baxter Healthcare Corp · Jun 1990
COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2
K901578 · Diagnostic Products Corp. · Apr 1990