Cleared Traditional

K845026 - AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY...

K845026 is an FDA 510(k) clearance for AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY..., manufactured by Amersham Corp.. The device is a Class 1 Chemistry device with product code JLS cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K845026 · Amersham Corp. · Chemistry device
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Feb 1985
Decision
36d
Days
Class 1
Risk

K845026 is an FDA 510(k) clearance for the AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on February 1, 1985 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1620 - 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 - K845026

510(k) Number K845026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1984
Decision Date February 01, 1985
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

JLS Device Classification - Class 1, General Controls

Product Code JLS Radioimmunoassay, Progesterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1620
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 - JLS Radioimmunoassay, Progesterone

All 32
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K845026.
DSL ANDROSTENEDIONE RIA (DSL #4200)
K854675 · Diagnostic Systems Laboratories, Inc. · Jan 1986
DSL PROGESTERONE RIA (DSL #3400)
K854649 · Diagnostic Systems Laboratories, Inc. · Dec 1985
LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT
K850056 · Leeco Diagnostics, Inc. · Feb 1985
IMMO PHASE DIRECT PROGESTERONE RADIO-
K830880 · Corning Medical & Scientific · Apr 1983
COAT-A-COUNT PROGESTERONE KIA KIT
K820534 · Diagnostic Products Corp. · Mar 1982
PROGESTERONE DIRECT RIA KIT (125I)
K811907 · Immunalysis Corporation · Jul 1981