Cleared Traditional

K964152 - UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964152 · Pharmacia, Inc. · Immunology device
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Apr 1997
Decision
189d
Days
Class 2
Risk

K964152 is an FDA 510(k) clearance for the UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Westervillle, US). The FDA issued a Cleared decision on April 23, 1997 after a review of 189 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 Pharmacia, Inc. devices

Submission Details

510(k) Number K964152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1996
Decision Date April 23, 1997
Days to Decision 189 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 104d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DGC Ige, 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.