Cleared Traditional

K913672 - PREALBUMIN IMMUNOLOGICAL NL TEST KIT

K913672 is the FDA 510(k) clearance for PREALBUMIN IMMUNOLOGICAL NL TEST KIT by The Binding Site, Ltd.. It is a Class 1 Immunology device (product code JZJ) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K913672 · The Binding Site, Ltd. · Immunology device
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Dec 1991
Decision
123d
Days
Class 1
Risk

K913672 is an FDA 510(k) clearance for the PREALBUMIN IMMUNOLOGICAL NL TEST KIT. Classified as Prealbumin, Antigen, Antiserum, Control (product code JZJ), Class I - General Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on December 20, 1991 after a review of 123 days - within the typical 510(k) review window.

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 The Binding Site, Ltd. devices

Submission Details

510(k) Number K913672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1991
Decision Date December 20, 1991
Days to Decision 123 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 104d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 8
Devices cleared under the same product code (JZJ) and FDA review panel - the closest regulatory comparables to K913672.
RANDOX PREALBUMIN
K000661 · Randox Laboratories, Ltd. · Apr 2000
TINA-QUANT PREALBUMIN
K972638 · Boehringer Mannheim Corp. · Jan 1998
HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT
K951966 · Kent Laboratories, Inc. · Jun 1995
QM300 PREALBUMIN ANTIBODY PACK
K883002 · Kallestad Diag, A Div. of Erbamont, Inc. · Sep 1988
ANTISERUM TO HUMAN PREALBUMIN
K850686 · Kent Laboratories, Inc. · Nov 1985
LASER PREALBUMIN TEST
K851912 · Behring Diagnostics, Inc. · Jun 1985