Cleared Traditional

K790710 - ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN

K790710 is an FDA 510(k) clearance for ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN, manufactured by Kent Laboratories, Inc.. The device is a Class 2 Immunology device with product code DDY cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K790710 · Kent Laboratories, Inc. · Immunology device
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Aug 1979
Decision
113d
Days
Class 2
Risk

K790710 is an FDA 510(k) clearance for the ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN. Classified as Alpha-2-macroglobulin, Fitc, Antigen, Antiserum, Control (product code DDY), Class II - Special Controls.

Submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5620 - 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 Kent Laboratories, Inc. devices

FDA 510(k) Submission Details - K790710

510(k) Number K790710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1979
Decision Date August 03, 1979
Days to Decision 113 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 105d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDY Device Classification - Class 2, Special Controls

Product Code DDY Alpha-2-macroglobulin, Fitc, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5620
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.