Cleared Traditional

K962919 - VITROS IMMUNODIAGNOSTIC SYSTEM

K962919 is the FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC SYSTEM by Johnson & Johnson Clinical Diagnostics, Inc.. It is a Class 1 Chemistry device (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

Submission Details

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.

Device Classification

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 25
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K962919.
TRIAGE STATMETER
K973547 · Biosite Incorporated · Jan 1998
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
K971103 · Tosoh Medics, Inc. · Jun 1997
FLUOROSCAN NEONATAL
K950415 · Isolab, Inc. · Sep 1995
OPUS MAGNUM ANALYZER
K926131 · Pb Diagnostic Systems, Inc. · Jun 1993
MICROLITE MICROTITER PLATE LUMINOMETER ML2200
K920888 · Dynatech Laboratories, Inc. · Mar 1992
STRATUS IINTELLECT IMMUNOASSAY SYSTEM
K913130 · Baxter Healthcare Corp · Sep 1991