Cleared Traditional

K964152 - UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH

K964152 is an FDA 510(k) clearance for UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL ..., manufactured by Pharmacia, Inc.. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K964152 · Pharmacia, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K964152

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 105d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGC Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DGC Ige, Antigen, Antiserum, Control

All 90
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K964152.
N LATEX IGE MONO REAGENT
K991787 · Dade Behring, Inc. · Jul 1999
BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
K983185 · Boehringer Mannheim Corp. · Nov 1998
AIA-PACK IGE II ASSAY
K972697 · Tosoh Medics, Inc. · Oct 1997
HY-TEC TOTAL IGE ENZYME IMMUNOASSAY
K940183 · Hycor Biomedical, Inc. · May 1994
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K934594 · Ciba Corning Diagnostics Corp. · Apr 1994
COBAS(R) CORE IGE TOTAL EIA
K930890 · Roche Diagnostic Systems, Inc. · Aug 1993