Cleared Traditional

K813413 - LECTIN H (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K813413 · American Dade · Pathology device
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Mar 1982
Decision
87d
Days
Class 2
Risk

K813413 is an FDA 510(k) clearance for the LECTIN H. Classified as Lectins And Protectins (product code KSI), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on March 4, 1982 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.9550 - the FDA pathology 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 American Dade devices

Submission Details

510(k) Number K813413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1981
Decision Date March 04, 1982
Days to Decision 87 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 77d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KSI Lectins And Protectins
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9550
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 Pathology devices follow this clearance model.