Cleared Traditional

K870117 - NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST

K870117 is an FDA 510(k) clearance for NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST, manufactured by Pro-Lab, Inc.. The device is a Class 1 Microbiology device with product code JSX cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K870117 · Pro-Lab, Inc. · Microbiology device
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Mar 1987
Decision
67d
Days
Class 1
Risk

K870117 is an FDA 510(k) clearance for the NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST. Classified as Kit, Identification, Neisseria Gonorrhoeae (product code JSX), Class I - General Controls.

Submitted by Pro-Lab, Inc. (Scarborough Ont, CA). The FDA issued a Cleared decision on March 20, 1987 after a review of 67 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K870117

510(k) Number K870117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1987
Decision Date March 20, 1987
Days to Decision 67 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
35d faster than avg
Panel avg: 102d · This submission: 67d
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.

Regulatory Peers - JSX Kit, Identification, Neisseria Gonorrhoeae

All 15
Devices cleared under the same product code (JSX) and FDA review panel - the closest regulatory comparables to K870117.
VISI-NEISSERIA
K913456 · Kev Connecticut Diagnostics, Inc. · Oct 1991
XACT NEISSERIA
K880511 · Austin Biological Laboratories · Aug 1988
MODIFIED IDS RAPID NH SYSTEM
K881501 · Innovative Diagnostic Systems, Inc. · May 1988
QUAD FERM +
K853544 · Analytical Products, Inc. · Sep 1985
NEISSERIA - KWIK PLUS
K852998 · Micro-Bio-Logics · Jul 1985
GONI-KIT
K852582 · Culture Kits, Inc. · Jul 1985
K870117 · NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST
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