Cleared Traditional Expedited

TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION (K981914) - FDA 510(k) Clearance

Class I Immunology device.

K981914 · The Binding Site, Ltd. · Immunology device
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Nov 1999
Decision
543d
Days
Class 1
Risk

K981914 is an FDA 510(k) clearance for the TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on November 26, 1999 after a review of 543 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - 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 K981914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1998
Decision Date November 26, 1999
Days to Decision 543 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
439d slower than avg
Panel avg: 104d · This submission: 543d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

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