Cleared Traditional

K850683 - 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2

K850683 is an FDA 510(k) clearance for 72 DETERM. SIZE RADIAL IMMUNODIFFUSION ..., manufactured by Kent Laboratories, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K850683

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
174d slower than avg
Panel avg: 105d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEB Device Classification - Class 2, Special Controls

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 11
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
RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI
K851282 · Cooper Biomedical, Inc. · May 1985
IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO
K812493 · Dako Corp. · Sep 1981
HUMAN ALPHA2 MACROGLOBULIN
K791340 · Beckman Instruments, Inc. · Aug 1979