Cleared Traditional

K800775 - ALDOCTK-125

K800775 is the FDA 510(k) clearance for ALDOCTK-125 by Sorin Biomedica, Fiat, USA, Inc.. It is a Class 2 Chemistry device (product code CJM) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K800775 · Sorin Biomedica, Fiat, USA, Inc. · Chemistry device
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Apr 1980
Decision
14d
Days
Class 2
Risk

K800775 is an FDA 510(k) clearance for the ALDOCTK-125. Classified as Radioimmunoassay, Aldosterone (product code CJM), Class II - Special Controls.

Submitted by Sorin Biomedica, Fiat, USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1980 after a review of 14 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 Sorin Biomedica, Fiat, USA, Inc. devices

Submission Details

510(k) Number K800775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1980
Decision Date April 21, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (CJM) and FDA review panel - the closest regulatory comparables to K800775.
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
125I-ALDOSTERONE RIA DIAG. KIT
K781504 · Abbott Laboratories · Nov 1978
125 I ALDOSTERONE RIA KIT
K771526 · Diagnostic Products Corp. · Aug 1977