Cleared Traditional

K923832 - PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION

K923832 is an FDA 510(k) clearance for PHARMACIA CAP SYSTEM IGE FEIA -- MODIFI..., manufactured by Kabi Pharmacia, Inc.. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K923832 · Kabi Pharmacia, Inc. · Immunology device
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Nov 1992
Decision
120d
Days
Class 2
Risk

K923832 is an FDA 510(k) clearance for the PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Kabi Pharmacia, Inc. (New Brunswick, US). The FDA issued a Cleared decision on November 25, 1992 after a review of 120 days - within the typical 510(k) review window.

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 Kabi Pharmacia, Inc. devices

FDA 510(k) Submission Details - K923832

510(k) Number K923832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1992
Decision Date November 25, 1992
Days to Decision 120 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
15d slower than avg
Panel avg: 105d · This submission: 120d
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 91
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K923832.
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ACS TOTAL IGE IMMUNOASSAY
K920372 · Ciba Corning Diagnostics Corp. · Apr 1992
KALLESTEAD TOTAL IGE MICROPLATE KIT
K912800 · Bio-Rad Laboratories, Inc. · Jul 1991