Cleared Traditional

K844135 - PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU

K844135 is an FDA 510(k) clearance for PLASMA CYCLIC ADENOSINE MONOPHOSPHATE B..., manufactured by Immuno Nuclear Corp.. The device is a Class 2 Chemistry device with product code CHO cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K844135 · Immuno Nuclear Corp. · Chemistry device
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Mar 1985
Decision
133d
Days
Class 2
Risk

K844135 is an FDA 510(k) clearance for the PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU. Classified as Radioimmunoassay, Cyclic Amp (product code CHO), Class II - Special Controls.

Submitted by Immuno Nuclear Corp. (Stillwater, US). The FDA issued a Cleared decision on March 5, 1985 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1230 - 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 Immuno Nuclear Corp. devices

FDA 510(k) Submission Details - K844135

510(k) Number K844135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date March 05, 1985
Days to Decision 133 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 slower than avg
Panel avg: 88d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CHO Device Classification - Class 2, Special Controls

Product Code CHO Radioimmunoassay, Cyclic Amp
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1230
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CHO Radioimmunoassay, Cyclic Amp

Devices cleared under the same product code (CHO) and FDA review panel - the closest regulatory comparables to K844135.
AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT)
K860253 · Amersham Corp. · Mar 1986
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K823504 · Immuno Nuclear Corp. · Jan 1983
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K811746 · King Diagnostics, Inc. · Jul 1981
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K811273 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1981