Cleared Traditional

K924769 - IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC

K924769 is an FDA 510(k) clearance for IMMUNOGLOBULINS G, manufactured by The Binding Site, Ltd.. The device is a Class 2 Immunology device with product code CFF cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K924769 · The Binding Site, Ltd. · Immunology device
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Feb 1993
Decision
153d
Days
Class 2
Risk

K924769 is an FDA 510(k) clearance for the IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC. Classified as Immunoelectrophoretic, Immunoglobulins, (g, A, M) (product code CFF), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on February 23, 1993 after a review of 153 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 - K924769

510(k) Number K924769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1992
Decision Date February 23, 1993
Days to Decision 153 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
48d slower than avg
Panel avg: 105d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFF Device Classification - Class 2, Special Controls

Product Code CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)

All 26
Devices cleared under the same product code (CFF) and FDA review panel - the closest regulatory comparables to K924769.
HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS
K960669 · Morax · Jul 1996
N-ASSAY TIA IGG
K933972 · Crestat Diagnostics, Inc. · Mar 1994
IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC
K924767 · The Binding Site, Ltd. · Feb 1993
REP IMMUNOFIX
K923658 · Helena Laboratories · Nov 1992
REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178
K892424 · Helena Laboratories · Jun 1989
PARAGON IMMUNOELECTROPHORESIS REAGENT
K823884 · Beckman Instruments, Inc. · Mar 1983