Cleared Traditional

K965048 - VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)

K965048 is an FDA 510(k) clearance for VITROS IMMUNODDIAGNOSTICS PRODUCTS RE C..., manufactured by Johnson & Johnson Clinical Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K965048 · Johnson & Johnson Clinical Diagnostics, Inc. · Chemistry device
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Jan 1997
Decision
40d
Days
Class 1
Risk

K965048 is an FDA 510(k) clearance for the VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015). Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on January 27, 1997 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 - K965048

510(k) Number K965048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1996
Decision Date January 27, 1997
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

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