Cleared Traditional

K864855 - AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT

K864855 is an FDA 510(k) clearance for AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT, 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 76-day FDA review.

K864855 · Amersham Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Feb 1987
Decision
76d
Days
Class 1
Risk

K864855 is an FDA 510(k) clearance for the AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT. 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 25, 1987 after a review of 76 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 - K864855

510(k) Number K864855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1986
Decision Date February 25, 1987
Days to Decision 76 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
12d faster than avg
Panel avg: 88d · This submission: 76d
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 40
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K864855.
AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144
K884100 · Amersham Corp. · Nov 1988
MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT
K880934 · Amersham Corp. · Apr 1988
PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH
K873431 · Serono Diagnostics, Inc. · Oct 1987
IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS
K854094 · Immuchem Corp. · Feb 1986
DSL ANDROSTENEDIONE RIA (DSL #4200)
K854675 · Diagnostic Systems Laboratories, Inc. · Jan 1986
DSL PROGESTERONE RIA (DSL #3400)
K854649 · Diagnostic Systems Laboratories, Inc. · Dec 1985