Cleared Traditional

EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN (K954933) - FDA 510(k) Clearance

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

K954933 · Johnson & Johnson Clinical Diagnostics, Inc. · Toxicology device
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Dec 1995
Decision
52d
Days
Class 2
Risk

K954933 is an FDA 510(k) clearance for the EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on December 18, 1995 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3030 - the FDA toxicology 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.

View all Johnson & Johnson Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K954933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1995
Decision Date December 18, 1995
Days to Decision 52 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 87d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDP Colorimetry, Acetaminophen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3030
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 Toxicology devices follow this clearance model.

Regulatory Peers - LDP Colorimetry, Acetaminophen

All 35
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K954933.
Acetaminophen
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DIMENSION VISTA FLEX REAGENT CARTRIDGES
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SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
K011465 · Beckman Coulter, Inc. · Jun 2001
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K002974 · Dade Behring, Inc. · Oct 2000