Cleared Traditional

K782013 - GONO-CELL

K782013 is an FDA 510(k) clearance for GONO-CELL, manufactured by Abbott Laboratories. The device is a Class 1 Microbiology device with product code JSX cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K782013 · Abbott Laboratories · Microbiology device
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Apr 1979
Decision
139d
Days
Class 1
Risk

K782013 is an FDA 510(k) clearance for the GONO-CELL. Classified as Kit, Identification, Neisseria Gonorrhoeae (product code JSX), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 23, 1979 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K782013

510(k) Number K782013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1978
Decision Date April 23, 1979
Days to Decision 139 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
37d slower than avg
Panel avg: 102d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

JSX Device Classification - Class 1, General Controls

Product Code JSX Kit, Identification, Neisseria Gonorrhoeae
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.