Cleared Traditional

K842966 - RENIN RADIOIMMUNOASSAY TEST KIT

K842966 is an FDA 510(k) clearance for RENIN RADIOIMMUNOASSAY TEST KIT, manufactured by Serono Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CIB cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K842966 · Serono Diagnostics, Inc. · Chemistry device
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Oct 1984
Decision
76d
Days
Class 2
Risk

K842966 is an FDA 510(k) clearance for the RENIN RADIOIMMUNOASSAY TEST KIT. Classified as Radioimmunoassay, Angiotensin I And Renin (product code CIB), Class II - Special Controls.

Submitted by Serono Diagnostics, Inc. (Bramtree, US). The FDA issued a Cleared decision on October 11, 1984 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1085 - 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.

FDA 510(k) Submission Details - K842966

510(k) Number K842966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1984
Decision Date October 11, 1984
Days to Decision 76 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
13d faster than avg
Panel avg: 89d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIB Device Classification - Class 2, Special Controls

Product Code CIB Radioimmunoassay, Angiotensin I And Renin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1085
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 - CIB Radioimmunoassay, Angiotensin I And Renin

All 15
Devices cleared under the same product code (CIB) and FDA review panel - the closest regulatory comparables to K842966.
AI-PHOTODIAGNOSTIC
K940004 · Pharmarceutical Discovery Corp. · Aug 1995
ACTIVE RENIN IMMUNORADIOMETRIC ASSAY
K925998 · Nichols Institute Diagnostics · Jan 1993
RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI
K850054 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1985
ANGIOTENSIN CONVERTING ENZYME
K833777 · Immuno-Diagnostic Laboratories · Jan 1984
RENAK
K831694 · Hoffmann-La Roche, Inc. · Jul 1983
ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY
K820616 · E. R. Squibb & Sons, Inc. · Mar 1982
K842966 · RENIN RADIOIMMUNOASSAY TEST KIT
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