Cleared Traditional

K791284 - ANTI-HUMAN KAPPA SERUM

K791284 is the FDA 510(k) clearance for ANTI-HUMAN KAPPA SERUM by Diagnostica, Inc.. It is a Class 2 Immunology device (product code DFH) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K791284 · Diagnostica, Inc. · Immunology device
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Nov 1979
Decision
140d
Days
Class 2
Risk

K791284 is an FDA 510(k) clearance for the ANTI-HUMAN KAPPA SERUM. Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1979 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostica, Inc. devices

Submission Details

510(k) Number K791284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1979
Decision Date November 27, 1979
Days to Decision 140 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 104d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFH Kappa, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 Immunology devices follow this clearance model.

Regulatory Peers - DFH Kappa, Antigen, Antiserum, Control

All 40
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K791284.
DAKO PAP KIT K504
K812485 · Dako Corp. · Feb 1982
IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA
K812661 · Dako Corp. · Sep 1981
ANTISERA TO HUMAN FREE KAPPA CHAINS
K802283 · Kallestad Laboratories, Inc. · Oct 1980
ANTISERUM TO RABBIT IGG H & L CHAIN
K790706 · Kent Laboratories, Inc. · Sep 1979
KAPPA SERUM (FREE) ANTI-HUMAN
K781027 · Icl Scientific · Jul 1978
KAPPA SERUM (FREE & BOUND) ANTI-HUMAN
K781028 · Icl Scientific · Jul 1978