Cleared Traditional

VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) (K964721) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964721 · Johnson & Johnson Clinical Diagnostics, Inc. · Chemistry device
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Dec 1996
Decision
23d
Days
Class 2
Risk

K964721 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 C.... Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 18, 1996 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 K964721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1996
Decision Date December 18, 1996
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 85
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K964721.
ACCESS TOTAL T4 ASSAY
K023369 · Beckman Coulter, Inc. · Dec 2002
ABBOTT ARCHITECT TOTAL T4
K983440 · Abbott Laboratories · Nov 1998
SYNCHRON SYSTEMS THYROXINE REAGENT
K971203 · Beckman Instruments, Inc. · May 1997
RADIAS NEONATAL T4 ENZYME IMMUNOASSAY
K951321 · Bio-Rad · Aug 1995
RADIAS TOTAL T4 ENZYME IMMUNOASSAY
K946163 · Bio-Rad · Feb 1995
COBAS (R) CORE T4 EIA
K932605 · Roche Diagnostic Systems, Inc. · Jan 1994