Cleared Traditional

K802913 - TAN DEM* - IGE KIT

K802913 is an FDA 510(k) clearance for TAN DEM* - IGE KIT, manufactured by Hybritech, Inc.. The device is a Class 2 Chemistry device with product code DGC cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K802913 · Hybritech, Inc. · Chemistry device
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May 1981
Decision
192d
Days
Class 2
Risk

K802913 is an FDA 510(k) clearance for the TAN DEM* - IGE KIT. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Hybritech, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 29, 1981 after a review of 192 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5510 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Hybritech, Inc. devices

FDA 510(k) Submission Details - K802913

510(k) Number K802913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1980
Decision Date May 29, 1981
Days to Decision 192 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 88d · This submission: 192d
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 Chemistry 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 K802913.
PHADEBAS/PHADEZYM IGE REAGENTS
K813189 · Pharmacia, Inc. · Dec 1981
VENTRE/SEP IGE RIA TEST SET
K811559 · Ventrex Laboratories, Inc. · Jul 1981
KALLESTAD QUANTITOPE LOW LEVEL IGE REAG
K811545 · Kallestad Laboratories, Inc. · Jun 1981
PHADEZYM IGE PRIST TEST
K810507 · Pharmacia, Inc. · Mar 1981
RIA KIT, QUANTITOPE IGE
K781904 · Kallestad Laboratories, Inc. · Feb 1979
LAS-R HUMAN IGE TEST
K780753 · Hyland Therapeutic Div., Travenol Laboratories · Jun 1978