Cleared Traditional

K863216 - NEIS NZY

K863216 is an FDA 510(k) clearance for NEIS NZY, manufactured by Carr-Scarborough Microbiologicals, Inc.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K863216 · Carr-Scarborough Microbiologicals, Inc. · Microbiology device
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Sep 1986
Decision
26d
Days
Class 1
Risk

K863216 is an FDA 510(k) clearance for the NEIS NZY. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Carr-Scarborough Microbiologicals, Inc. (Stone Mountain, US). The FDA issued a Cleared decision on September 15, 1986 after a review of 26 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.

View all Carr-Scarborough Microbiologicals, Inc. devices

FDA 510(k) Submission Details - K863216

510(k) Number K863216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1986
Decision Date September 15, 1986
Days to Decision 26 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
76d faster than avg
Panel avg: 102d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

JTO Device Classification - Class 1, General Controls

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
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 - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 196
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