Cleared Traditional

K913672 - PREALBUMIN IMMUNOLOGICAL NL TEST KIT

K913672 is an FDA 510(k) clearance for PREALBUMIN IMMUNOLOGICAL NL TEST KIT, manufactured by The Binding Site, Ltd.. The device is a Class 1 Immunology device with 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

FDA 510(k) Submission Details - K913672

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
18d slower than avg
Panel avg: 105d · This submission: 123d
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 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
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