Cleared Traditional

K880934 - MODIFIED AMERLEX-M PROGESTERONE RADIOIM...

K880934 is an FDA 510(k) clearance for MODIFIED AMERLEX-M PROGESTERONE RADIOIM..., 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 42-day FDA review.

K880934 · Amersham Corp. · Chemistry device
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Apr 1988
Decision
42d
Days
Class 1
Risk

K880934 is an FDA 510(k) clearance for the MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. 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 April 18, 1988 after a review of 42 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 - K880934

510(k) Number K880934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1988
Decision Date April 18, 1988
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
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 K880934.
ENZYMUN-TEST PROGESTERONE
K910683 · Boehringer Mannheim Corp. · Apr 1991
DELFIA PROGESTERONE KIT
K890428 · Pharmacia, Inc. · Feb 1989
AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144
K884100 · Amersham Corp. · Nov 1988
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT
K864855 · Amersham Corp. · Feb 1987
DSL ANDROSTENEDIONE RIA (DSL #4200)
K854675 · Diagnostic Systems Laboratories, Inc. · Jan 1986
DSL PROGESTERONE RIA (DSL #3400)
K854649 · Diagnostic Systems Laboratories, Inc. · Dec 1985