Cleared Traditional

K092450 - HUMAN IGD KIT FOR USE ON SPAPLUS

K092450 is an FDA 510(k) clearance for HUMAN IGD KIT FOR USE ON SPAPLUS, manufactured by The Binding Site. The device is a Class 2 Immunology device with product code CZJ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K092450 · The Binding Site · Immunology device
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Dec 2009
Decision
140d
Days
Class 2
Risk

K092450 is an FDA 510(k) clearance for the HUMAN IGD KIT FOR USE ON SPAPLUS. Classified as Igd, Antigen, Antiserum, Control (product code CZJ), Class II - Special Controls.

Submitted by The Binding Site (Los Angeles, US). The FDA issued a Cleared decision on December 28, 2009 after a review of 140 days - within the typical 510(k) review window.

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 devices

FDA 510(k) Submission Details - K092450

510(k) Number K092450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2009
Decision Date December 28, 2009
Days to Decision 140 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 104d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CZJ Device Classification - Class 2, Special Controls

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

All 7
Devices cleared under the same product code (CZJ) and FDA review panel - the closest regulatory comparables to K092450.
IGD DIAGNOSTIC TEST KITS
K051299 · The Binding Site, Ltd. · Nov 2005
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