Cleared Traditional

K863327 - IMMPULSE IGE ASSAY REAGENTS

K863327 is an FDA 510(k) clearance for IMMPULSE IGE ASSAY REAGENTS, manufactured by Sclavo, Inc.. The device is a Class 2 Immunology device with product code DGP cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K863327 · Sclavo, Inc. · Immunology device
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Dec 1986
Decision
98d
Days
Class 2
Risk

K863327 is an FDA 510(k) clearance for the IMMPULSE IGE ASSAY REAGENTS. Classified as Ige, Fitc, Antigen, Antiserum, Control (product code DGP), Class II - Special Controls.

Submitted by Sclavo, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 3, 1986 after a review of 98 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 Sclavo, Inc. devices

FDA 510(k) Submission Details - K863327

510(k) Number K863327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1986
Decision Date December 03, 1986
Days to Decision 98 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 105d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGP Device Classification - Class 2, Special Controls

Product Code DGP Ige, Fitc, 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.