Cleared Traditional

K802913 - TAN DEM* - IGE KIT

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

K802913 · Hybritech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 Chemistry devices follow this clearance model.

Regulatory Peers - DGC Ige, Antigen, Antiserum, Control

All 83
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