Cleared Traditional

K781504 - 125I-ALDOSTERONE RIA DIAG. KIT

K781504 is an FDA 510(k) clearance for 125I-ALDOSTERONE RIA DIAG. KIT, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CJM cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K781504 · Abbott Laboratories · Chemistry device
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Nov 1978
Decision
84d
Days
Class 2
Risk

K781504 is an FDA 510(k) clearance for the 125I-ALDOSTERONE RIA DIAG. KIT. Classified as Radioimmunoassay, Aldosterone (product code CJM), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 22, 1978 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1045 - 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.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K781504

510(k) Number K781504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1978
Decision Date November 22, 1978
Days to Decision 84 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
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJM Device Classification - Class 2, Special Controls

Product Code CJM Radioimmunoassay, Aldosterone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1045
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 - CJM Radioimmunoassay, Aldosterone

All 7
Devices cleared under the same product code (CJM) and FDA review panel - the closest regulatory comparables to K781504.
DSL ACTIVE ALDOSTERONE RIA (DSL 8600)
K943397 · Diagnostic Systems Laboratories, Inc. · Feb 1995
DSL ACTIVE ALDOSTERONE (DSL 8600)
K921205 · Diagnostic Systems Laboratories, Inc. · Jul 1992
COAT-A-COUNT NO-EXTRACTION ALDOSTERONE
K831178 · Diagnostic Products Corp. · May 1983
125 I ALDOSTERONE RIA KIT
K771526 · Diagnostic Products Corp. · Aug 1977