Cleared Traditional

K863858 - TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE--

K863858 is an FDA 510(k) clearance for TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE--, manufactured by Hybritech, Inc.. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K863858 · Hybritech, Inc. · Immunology device
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Nov 1986
Decision
31d
Days
Class 2
Risk

K863858 is an FDA 510(k) clearance for the TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE--. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on November 3, 1986 after a review of 31 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 Hybritech, Inc. devices

FDA 510(k) Submission Details - K863858

510(k) Number K863858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1986
Decision Date November 03, 1986
Days to Decision 31 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
74d faster than avg
Panel avg: 105d · This submission: 31d
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 K863858.
IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064
K874406 · Medix Biotech, Inc. · Nov 1987
ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5
K872913 · Diagnostic Products Corp. · Sep 1987
UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE
K864142 · United Biotech, Inc. · Dec 1986
ENZYMUN-TEST(R) IGE
K863822 · Boehringer Mannheim Corp. · Oct 1986
TIMOTHY ALLERGEN DISC
K862174 · Immuno Nuclear Corp. · Aug 1986
QUIDEL ALLERGY SCREEN
K861171 · Quidel Corp. · Apr 1986