Cleared Traditional

IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS (K854094) - FDA 510(k) Clearance

Class I Chemistry device.

K854094 · Immuchem Corp. · Chemistry device
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Feb 1986
Decision
144d
Days
Class 1
Risk

K854094 is an FDA 510(k) clearance for the IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Immuchem Corp. (Carson, US). The FDA issued a Cleared decision on February 28, 1986 after a review of 144 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 Immuchem Corp. devices

Submission Details

510(k) Number K854094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1985
Decision Date February 28, 1986
Days to Decision 144 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 88d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 10
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K854094.
AFFINITY PRG
K920230 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
MILENIA PROGESTERONE
K911512 · Diagnostic Products Corp. · May 1991
ENZYMUN-TEST PROGESTERONE
K910683 · Boehringer Mannheim Corp. · Apr 1991
COAT-A-COUNT PROGESTERONE KIA KIT
K820534 · Diagnostic Products Corp. · Mar 1982
REAGENT SYSTEM, PROGESTERONE, ARIA
K770732 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1977