Cleared Traditional

K000701 - HUMAN IGG SUBCLASS KIT USE WITH THE BEC...

K000701 is the FDA 510(k) clearance for HUMAN IGG SUBCLASS KIT USE WITH THE BEC... by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code CFN) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K000701 · The Binding Site, Ltd. · Immunology device
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Apr 2000
Decision
57d
Days
Class 2
Risk

K000701 is an FDA 510(k) clearance for the HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER. Classified as Method, Nephelometric, Immunoglobulins (g, A, M) (product code CFN), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on April 27, 2000 after a review of 57 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 K000701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2000
Decision Date April 27, 2000
Days to Decision 57 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
47d faster than avg
Panel avg: 104d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFN Method, Nephelometric, 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 - CFN Method, Nephelometric, Immunoglobulins (g, A, M)

All 51
Devices cleared under the same product code (CFN) and FDA review panel - the closest regulatory comparables to K000701.
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
K012296 · The Binding Site, Ltd. · Aug 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
K012291 · The Binding Site, Ltd. · Aug 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T
K012295 · The Binding Site, Ltd. · Aug 2001
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB
K993547 · Beckman Coulter, Inc. · Feb 2000
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR
K993549 · Beckman Coulter, Inc. · Feb 2000
WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
K993924 · Wako Chemicals USA, Inc. · Jan 2000