Cleared Traditional

K822115 - SERAGAN ACTH125 I-RIA KIT

K822115 is an FDA 510(k) clearance for SERAGAN ACTH125 I-RIA KIT, manufactured by Seragen Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CKG cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K822115 · Seragen Diagnostics, Inc. · Chemistry device
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Oct 1982
Decision
91d
Days
Class 2
Risk

K822115 is an FDA 510(k) clearance for the SERAGAN ACTH125 I-RIA KIT. Classified as Radioimmunoassay, Acth (product code CKG), Class II - Special Controls.

Submitted by Seragen Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 18, 1982 after a review of 91 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 Seragen Diagnostics, Inc. devices

FDA 510(k) Submission Details - K822115

510(k) Number K822115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1982
Decision Date October 18, 1982
Days to Decision 91 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
3d slower than avg
Panel avg: 88d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CKG Device Classification - Class 2, Special Controls

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.