Cleared Traditional

K021081 - HUMAN IGG SUBCLASS LIQUID REAGENT KITS ...

K021081 is the FDA 510(k) clearance for HUMAN IGG SUBCLASS LIQUID REAGENT KITS ... by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code DFZ) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K021081 · The Binding Site, Ltd. · Immunology device
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Jun 2002
Decision
75d
Days
Class 2
Risk

K021081 is an FDA 510(k) clearance for the HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBID.... Classified as Igg (gamma Chain Specific), Antigen, Antiserum, Control (product code DFZ), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on June 17, 2002 after a review of 75 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 K021081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2002
Decision Date June 17, 2002
Days to Decision 75 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
29d faster than avg
Panel avg: 104d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFZ Igg (gamma Chain Specific), 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 - DFZ Igg (gamma Chain Specific), Antigen, Antiserum, Control

Devices cleared under the same product code (DFZ) and FDA review panel - the closest regulatory comparables to K021081.
DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG
K092283 · Siemens Healthcare Diagnostics · Oct 2009
BOEHRINGER MANNHEIM IGG ASSAY
K955906 · Boehringer Mannheim Corp. · Feb 1996
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K940422 · The Binding Site, Ltd. · May 1994
AUTOMATED IMMUNOPRECIPITIN METHOD/ICG
K803272 · Icl Scientific · Jan 1981
ANTISERUM TO RABBIT IMMUNOGLOBULIN
K790709 · Kent Laboratories, Inc. · Aug 1979
ANTISERA TO RABBIT IMMUNOGLOBULIN
K790720 · Kent Laboratories, Inc. · Aug 1979