Cleared Traditional

K962919 - VITROS IMMUNODIAGNOSTIC SYSTEM

K962919 is an FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC SYSTEM, manufactured by Johnson & Johnson Clinical Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code KHO cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K962919 · Johnson & Johnson Clinical Diagnostics, Inc. · Chemistry device
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Oct 1996
Decision
84d
Days
Class 1
Risk

K962919 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC SYSTEM. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on October 18, 1996 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2560 - the FDA in vitro diagnostics and chemistry 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 Johnson & Johnson Clinical Diagnostics, Inc. devices

FDA 510(k) Submission Details - K962919

510(k) Number K962919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1996
Decision Date October 18, 1996
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

KHO Device Classification - Class 1, General Controls

Product Code KHO Fluorometer, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2560
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 - KHO Fluorometer, For Clinical Use

All 31
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