Cleared Traditional

K850053 - BACI 6 -ADRENOCORTICOTROOP HORMONE

K850053 is the FDA 510(k) clearance for BACI 6 -ADRENOCORTICOTROOP HORMONE by Euro-Diagnostics BV. It is a Class 2 Chemistry device (product code CKG) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K850053 · Euro-Diagnostics BV · Chemistry device
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Apr 1985
Decision
90d
Days
Class 2
Risk

K850053 is an FDA 510(k) clearance for the BACI 6 -ADRENOCORTICOTROOP HORMONE. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Euro-Diagnostics BV (Old Greenwich, US). The FDA issued a Cleared decision on April 8, 1985 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1025 - 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 Euro-Diagnostics BV devices

Submission Details

510(k) Number K850053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1985
Decision Date April 08, 1985
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CKG Radioimmunoassay, Acth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1025
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 - CKG Radioimmunoassay, Acth

All 13
Devices cleared under the same product code (CKG) and FDA review panel - the closest regulatory comparables to K850053.
INCSTAR ACTH IRMA
K940271 · Incstar Corp. · Aug 1994
MODIFIED DSL-2300 ACTH RIA
K900147 · Diagnostic Systems Laboratories, Inc. · Mar 1990
ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES
K882741 · Nichols Institute Diagnostics · Aug 1988
ACTH RIA
K844181 · Syncor Intl. Corp. · Nov 1984
ACTH NORMAL RANGE
K842249 · Diagnostic Systems Laboratories, Inc. · Aug 1984
DPC ACTH KIT
K840018 · Diagnostic Products Corp. · Mar 1984