Cleared Traditional

K955286 - EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCO...

K955286 is the FDA 510(k) clearance for EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCO... by Johnson & Johnson Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K955286 · Johnson & Johnson Clinical Diagnostics, Inc. · Chemistry device
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May 1996
Decision
183d
Days
Class 2
Risk

K955286 is an FDA 510(k) clearance for the EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU). Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on May 17, 1996 after a review of 183 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Johnson & Johnson Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K955286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1995
Decision Date May 17, 1996
Days to Decision 183 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
95d slower than avg
Panel avg: 88d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CGA Glucose Oxidase, Glucose

All 196
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K955286.
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K944459 · Boehringer Mannheim Corp. · Apr 1996
ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS
K952875 · Boehringer Mannheim Corp. · Nov 1995
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K952621 · Radiometer America, Inc. · Oct 1995