Cleared Traditional

K791749 - INDIRECT IMMUNO ENZYME

K791749 is the FDA 510(k) clearance for INDIRECT IMMUNO ENZYME by Clinical Sciences, Inc.. It is a Class 2 Immunology device (product code DAA) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K791749 · Clinical Sciences, Inc. · Immunology device
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Oct 1979
Decision
37d
Days
Class 2
Risk

K791749 is an FDA 510(k) clearance for the INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL. Classified as Igg, Peroxidase, Antigen, Antiserum, Control (product code DAA), Class II - Special Controls.

Submitted by Clinical Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979 after a review of 37 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 Clinical Sciences, Inc. devices

Submission Details

510(k) Number K791749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1979
Decision Date October 17, 1979
Days to Decision 37 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 104d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DAA Igg, Peroxidase, 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.