Cleared Traditional

K894049 - IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT

K894049 is an FDA 510(k) clearance for IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSA..., manufactured by Pantex, Div. Bio-Analysis, Inc.. The device is a Class 1 Chemistry device with product code JLS cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K894049 · Pantex, Div. Bio-Analysis, Inc. · Chemistry device
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Sep 1989
Decision
93d
Days
Class 1
Risk

K894049 is an FDA 510(k) clearance for the IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Pantex, Div. Bio-Analysis, Inc. (Santa Monica, US). The FDA issued a Cleared decision on September 8, 1989 after a review of 93 days - within the typical 510(k) review window.

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: 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 Pantex, Div. Bio-Analysis, Inc. devices

FDA 510(k) Submission Details - K894049

510(k) Number K894049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1989
Decision Date September 08, 1989
Days to Decision 93 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 88d · This submission: 93d
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 41
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K894049.
SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)
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K911512 · Diagnostic Products Corp. · May 1991
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
AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144
K884100 · Amersham Corp. · Nov 1988