Cleared Traditional

K864170 - LEECO VIS-CUBE STREP A (EIA)

K864170 is the FDA 510(k) clearance for LEECO VIS-CUBE STREP A (EIA) by Leeco Diagnostics, Inc.. It is a Class 1 Microbiology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K864170 · Leeco Diagnostics, Inc. · Microbiology device
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Feb 1987
Decision
102d
Days
Class 1
Risk

K864170 is an FDA 510(k) clearance for the LEECO VIS-CUBE STREP A (EIA). Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Leeco Diagnostics, Inc. (Southfield, US). The FDA issued a Cleared decision on February 3, 1987 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - the FDA microbiology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Leeco Diagnostics, Inc. devices

Submission Details

510(k) Number K864170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1986
Decision Date February 03, 1987
Days to Decision 102 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 102d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTZ Antisera, All Groups, Streptococcus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
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.

Regulatory Peers - GTZ Antisera, All Groups, Streptococcus Spp.

All 62
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