Cleared Traditional

K884100 - AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144

K884100 is an FDA 510(k) clearance for AMERLITE PROGESTERONE ASSAY, 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 43-day FDA review.

K884100 · Amersham Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Nov 1988
Decision
43d
Days
Class 1
Risk

K884100 is an FDA 510(k) clearance for the AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144. 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 November 10, 1988 after a review of 43 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 - K884100

510(k) Number K884100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1988
Decision Date November 10, 1988
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
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 K884100.
ENZYMUN-TEST PROGESTERONE
K910683 · Boehringer Mannheim Corp. · Apr 1991
DELFIA PROGESTERONE KIT
K890428 · Pharmacia, Inc. · Feb 1989
PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY
K884794 · Serono-Baker Diagnostics, Inc. · Feb 1989
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
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT
K864855 · Amersham Corp. · Feb 1987