Cleared Traditional

K791284 - ANTI-HUMAN KAPPA SERUM

K791284 is an FDA 510(k) clearance for ANTI-HUMAN KAPPA SERUM, manufactured by Diagnostica, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K791284

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
35d slower than avg
Panel avg: 105d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFH Device Classification - Class 2, Special Controls

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 56
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