Cleared Traditional

K862665 - NOVACYTE-U

K862665 is an FDA 510(k) clearance for NOVACYTE-U, manufactured by Xsirius Medical, Inc.. The device is a Class 1 Pathology device with product code KDT cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K862665 · Xsirius Medical, Inc. · Pathology device
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Sep 1986
Decision
52d
Days
Class 1
Risk

K862665 is an FDA 510(k) clearance for the NOVACYTE-U. Classified as Container, Specimen Mailer And Storage, Sterile (product code KDT), Class I - General Controls.

Submitted by Xsirius Medical, Inc. (Rolling Hills Estates, US). The FDA issued a Cleared decision on September 4, 1986 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3250 - the FDA pathology 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 - K862665

510(k) Number K862665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1986
Decision Date September 04, 1986
Days to Decision 52 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 78d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

KDT Device Classification - Class 1, General Controls

Product Code KDT Container, Specimen Mailer And Storage, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3250
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 - KDT Container, Specimen Mailer And Storage, Sterile

All 8
Devices cleared under the same product code (KDT) and FDA review panel - the closest regulatory comparables to K862665.
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K822870 · American Scientific Products · Nov 1982
PREFILLED SPECIMEN CONTAINER
K820246 · Sage Products, Inc. · Feb 1982
K862665 · NOVACYTE-U
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