Cleared Traditional

K823507 - TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY

K823507 is the FDA 510(k) clearance for TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY by Hybritech, Inc.. It is a Class 2 Chemistry device (product code DGC) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K823507 · Hybritech, Inc. · Chemistry device
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Dec 1982
Decision
34d
Days
Class 2
Risk

K823507 is an FDA 510(k) clearance for the TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Hybritech, Inc. (Walker, US). The FDA issued a Cleared decision on December 28, 1982 after a review of 34 days - a notably fast clearance 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: 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

Submission Details

510(k) Number K823507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1982
Decision Date December 28, 1982
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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
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