Cleared Traditional

K982100 - IGG AND IGG SUBCLASS NEPHELOMETRIC DIAG...

K982100 is the FDA 510(k) clearance for IGG AND IGG SUBCLASS NEPHELOMETRIC DIAG... by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code CFN) cleared through the Traditional 510(k) pathway after a 553-day FDA review.

K982100 · The Binding Site, Ltd. · Immunology device
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Dec 1999
Decision
553d
Days
Class 2
Risk

K982100 is an FDA 510(k) clearance for the IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS. 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 20, 1999 after a review of 553 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all The Binding Site, Ltd. devices

Submission Details

510(k) Number K982100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1998
Decision Date December 20, 1999
Days to Decision 553 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
449d slower than avg
Panel avg: 104d · This submission: 553d
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 K982100.
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K982382 · Roche Diagnostic Systems, Inc. · Sep 1998
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