Cleared Traditional

K954933 - EKTACHEM CLINICAL CHEMISTRY SLIDE FOR A...

K954933 is the FDA 510(k) clearance for EKTACHEM CLINICAL CHEMISTRY SLIDE FOR A... by Johnson & Johnson Clinical Diagnostics, Inc.. It is a Class 2 Toxicology device (product code LDP) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

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
Combination Product No
PCCP Authorized No
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 28
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K954933.
ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30.
K981059 · Diagnostic Chemicals , Ltd. · May 1998
ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10
K980031 · Diagnostic Chemicals , Ltd. · Mar 1998
ACETAMINOPHEN SERUM TOX EIA ASSAY
K961373 · Diagnostic Reagents, Inc. · Jul 1996
ACETAMINOPHEN ASSAY
K952949 · Diagnostic Chemicals , Ltd. · Sep 1995
AXSYM ACETAMINOPHEN
K953094 · Abbott Laboratories · Aug 1995
ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13
K885097 · Diagnostic Chemicals, Ltd. (Usa) · Jan 1989