Cleared Traditional

K850686 - ANTISERUM TO HUMAN PREALBUMIN

K850686 is an FDA 510(k) clearance for ANTISERUM TO HUMAN PREALBUMIN, manufactured by Kent Laboratories, Inc.. The device is a Class 1 Immunology device with product code JZJ cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K850686 · Kent Laboratories, Inc. · Immunology device
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Nov 1985
Decision
253d
Days
Class 1
Risk

K850686 is an FDA 510(k) clearance for the ANTISERUM TO HUMAN PREALBUMIN. Classified as Prealbumin, Antigen, Antiserum, Control (product code JZJ), Class I - General Controls.

Submitted by Kent Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on November 1, 1985 after a review of 253 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5060 - 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 - K850686

510(k) Number K850686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1985
Decision Date November 01, 1985
Days to Decision 253 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
148d slower than avg
Panel avg: 105d · This submission: 253d
Pathway characteristics
Predicate-based equivalence.

JZJ Device Classification - Class 1, General Controls

Product Code JZJ Prealbumin, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5060
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JZJ Prealbumin, Antigen, Antiserum, Control

All 10
Devices cleared under the same product code (JZJ) and FDA review panel - the closest regulatory comparables to K850686.
SPQ(TM) TEST SYSTEM FOR PREALBUMIN
K884297 · Atlantic Antibodies · Nov 1988
SPQ(TM) TEST SYSTEM FOR MICROALBUMIN
K884298 · Atlantic Antibodies · Nov 1988
QM300 PREALBUMIN ANTIBODY PACK
K883002 · Kallestad Diag, A Div. of Erbamont, Inc. · Sep 1988
LASER PREALBUMIN TEST
K851912 · Behring Diagnostics, Inc. · Jun 1985
PREALBUMIN ENZYME IMMUNOASSAY
K821135 · Abbott Laboratories · May 1983
LAS-R HUMAN PREALBUMIN TEST
K772329 · Hyland Therapeutic Div., Travenol Laboratories · Feb 1978