Cleared Traditional

K981912 - HUMAN IGA SUBCLASS BNII COMBI KIT

K981912 is an FDA 510(k) clearance for HUMAN IGA SUBCLASS BNII COMBI KIT, manufactured by The Binding Site, Ltd.. The device is a Class 2 Immunology device with product code CFN cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K981912 · The Binding Site, Ltd. · Immunology device
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Dec 1998
Decision
186d
Days
Class 2
Risk

K981912 is an FDA 510(k) clearance for the HUMAN IGA SUBCLASS BNII COMBI KIT. 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 December 4, 1998 after a review of 186 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

FDA 510(k) Submission Details - K981912

510(k) Number K981912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1998
Decision Date December 04, 1998
Days to Decision 186 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
81d slower than avg
Panel avg: 105d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFN Device Classification - Class 2, Special Controls

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 56
Devices cleared under the same product code (CFN) and FDA review panel - the closest regulatory comparables to K981912.
WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
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K981784 · The Binding Site, Ltd. · Dec 1999
IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
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COBAS INTEGRA REAGENT CASSETTES
K982382 · Roche Diagnostic Systems, Inc. · Sep 1998
N-ASSAY TIA IGM
K933970 · Crestat Diagnostics, Inc. · Mar 1994
N-ASSAY TIA IGA
K933971 · Crestat Diagnostics, Inc. · Mar 1994