Cleared Traditional

K051299 - IGD DIAGNOSTIC TEST KITS

K051299 is the FDA 510(k) clearance for IGD DIAGNOSTIC TEST KITS by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code CZJ) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K051299 · The Binding Site, Ltd. · Immunology device
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Nov 2005
Decision
189d
Days
Class 2
Risk

K051299 is an FDA 510(k) clearance for the IGD DIAGNOSTIC TEST KITS. Classified as Igd, Antigen, Antiserum, Control (product code CZJ), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on November 23, 2005 after a review of 189 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

Submission Details

510(k) Number K051299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2005
Decision Date November 23, 2005
Days to Decision 189 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
85d slower than avg
Panel avg: 104d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZJ Igd, Antigen, Antiserum, Control
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 - CZJ Igd, Antigen, Antiserum, Control

Devices cleared under the same product code (CZJ) and FDA review panel - the closest regulatory comparables to K051299.
SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT
K002561 · The Binding Site, Ltd. · Oct 2000
HUMAN IGD IMMUNOLOGICAL NL TEST KIT
K913671 · The Binding Site, Ltd. · Dec 1991
QM300 CALIBRATOR D PACK
K883001 · Kallestad Diag, A Div. of Erbamont, Inc. · Sep 1988
TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410
K872834 · Helena Laboratories · Aug 1987
DETERM. SIZE 72 RADIAL-HUMAN IGD
K831956 · Kent Laboratories, Inc. · Jul 1983
LAS-R HUMAN IGD TEST
K772327 · Hyland Therapeutic Div., Travenol Laboratories · Feb 1978