Cleared Traditional

LEAP STREP TEST KIT (K833738) - FDA 510(k) Clearance

Class I Immunology device.

K833738 · Cooper Biomedical, Inc. · Immunology device
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Dec 1983
Decision
63d
Days
Class 1
Risk

K833738 is an FDA 510(k) clearance for the LEAP STREP TEST KIT. Classified as Exoenzymes, Multiple, Streptococcal (product code GTP), Class I - General Controls.

Submitted by Cooper Biomedical, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3720 - 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 Cooper Biomedical, Inc. devices

Submission Details

510(k) Number K833738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1983
Decision Date December 27, 1983
Days to Decision 63 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 104d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTP Exoenzymes, Multiple, Streptococcal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3720
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.