Cleared Traditional

K854094 - IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS

K854094 is an FDA 510(k) clearance for IMMUCHEM COVALENT COAT A SOLID PHASE RA..., manufactured by Immuchem Corp.. The device is a Class 1 Chemistry device with product code JLS cleared through the Traditional 510(k) pathway after a 144-day FDA review.

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

FDA 510(k) Submission Details - K854094

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 88d · This submission: 144d
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 K854094.
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
DSL ANDROSTENEDIONE RIA (DSL #4200)
K854675 · Diagnostic Systems Laboratories, Inc. · Jan 1986
DSL PROGESTERONE RIA (DSL #3400)
K854649 · Diagnostic Systems Laboratories, Inc. · Dec 1985
LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT
K850056 · Leeco Diagnostics, Inc. · Feb 1985