Cleared Traditional

K002561 - SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRA...

K002561 is the FDA 510(k) clearance for SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRA... by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code CZJ) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K002561 · The Binding Site, Ltd. · Immunology device
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Oct 2000
Decision
70d
Days
Class 2
Risk

K002561 is an FDA 510(k) clearance for the SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT. 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 October 26, 2000 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Binding Site, Ltd. devices

Submission Details

510(k) Number K002561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2000
Decision Date October 26, 2000
Days to Decision 70 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
34d faster than avg
Panel avg: 104d · This submission: 70d
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 K002561.
IGD DIAGNOSTIC TEST KITS
K051299 · The Binding Site, Ltd. · Nov 2005
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