Cleared Traditional

K920372 - ACS TOTAL IGE IMMUNOASSAY

K920372 is an FDA 510(k) clearance for ACS TOTAL IGE IMMUNOASSAY, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K920372 · Ciba Corning Diagnostics Corp. · Immunology device
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Apr 1992
Decision
71d
Days
Class 2
Risk

K920372 is an FDA 510(k) clearance for the ACS TOTAL IGE IMMUNOASSAY. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on April 8, 1992 after a review of 71 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K920372

510(k) Number K920372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1992
Decision Date April 08, 1992
Days to Decision 71 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
33d faster than avg
Panel avg: 104d · This submission: 71d
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 86
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K920372.
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PHARMACIA SPECIFIC IGE CONTROL
K911631 · Pharmacia, Inc. · Apr 1991
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K910082 · Quidel Corp. · Mar 1991