Cleared Traditional

GOAR ANTI-HUMAN LAMBODA CHAIN (K791115) - FDA 510(k) Clearance

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

K791115 · Protos Laboratories · Toxicology device
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Aug 1979
Decision
49d
Days
Class 2
Risk

K791115 is an FDA 510(k) clearance for the GOAR ANTI-HUMAN LAMBODA CHAIN. Classified as Lambda, Antigen, Antiserum, Control (product code DEH), Class II - Special Controls.

Submitted by Protos Laboratories (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 866.5550 - the FDA toxicology 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 Protos Laboratories devices

Submission Details

510(k) Number K791115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1979
Decision Date August 03, 1979
Days to Decision 49 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 87d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEH Lambda, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 Toxicology devices follow this clearance model.