Cleared Traditional

K850683 - 72 DETERM. SIZE RADIAL IMMUNODIFFUSION ...

K850683 is the FDA 510(k) clearance for 72 DETERM. SIZE RADIAL IMMUNODIFFUSION ... by Kent Laboratories, Inc.. It is a Class 2 Immunology device (product code DEB) cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K850683 · Kent Laboratories, Inc. · Immunology device
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Nov 1985
Decision
279d
Days
Class 2
Risk

K850683 is an FDA 510(k) clearance for the 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2. Classified as Alpha-2-macroglobulin, Antigen, Antiserum, Control (product code DEB), Class II - Special Controls.

Submitted by Kent Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on November 27, 1985 after a review of 279 days - an extended review cycle.

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

Submission Details

510(k) Number K850683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1985
Decision Date November 27, 1985
Days to Decision 279 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
175d slower than avg
Panel avg: 104d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEB Alpha-2-macroglobulin, 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.

Regulatory Peers - DEB Alpha-2-macroglobulin, Antigen, Antiserum, Control

All 10
Devices cleared under the same product code (DEB) and FDA review panel - the closest regulatory comparables to K850683.
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
K974564 · Beckman Instruments, Inc. · Feb 1998
ALPHA-2 MACROGLOBULIN TEST RID KIT
K914389 · The Binding Site, Ltd. · Dec 1991
QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK
K896483 · Kallestad Diag, A Div. of Erbamont, Inc. · Dec 1989
IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO
K812493 · Dako Corp. · Sep 1981
HUMAN ALPHA2 MACROGLOBULIN
K791340 · Beckman Instruments, Inc. · Aug 1979
ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY
K772246 · Kallestad Laboratories, Inc. · Dec 1977