Cleared Traditional

K991787 - N LATEX IGE MONO REAGENT

K991787 is the FDA 510(k) clearance for N LATEX IGE MONO REAGENT by Dade Behring, Inc.. It is a Class 2 Immunology device (product code DGC) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K991787 · Dade Behring, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
43d
Days
Class 2
Risk

K991787 is an FDA 510(k) clearance for the N LATEX IGE MONO REAGENT. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on July 7, 1999 after a review of 43 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K991787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1999
Decision Date July 07, 1999
Days to Decision 43 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
61d faster than avg
Panel avg: 104d · This submission: 43d
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.

Regulatory Peers - DGC Ige, Antigen, Antiserum, Control

All 75
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K991787.
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
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RANDOX IGE
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SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
K002560 · The Binding Site, Ltd. · Oct 2000
BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
K983185 · Boehringer Mannheim Corp. · Nov 1998
UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
K964152 · Pharmacia, Inc. · Apr 1997
HY-TEC TOTAL IGE ENZYME IMMUNOASSAY
K940183 · Hycor Biomedical, Inc. · May 1994