Cleared Traditional

WAKO GLUCOSE C (K842221) - FDA 510(k) Clearance

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

K842221 · Wako Pure Chemical Industries, Ltd. · Chemistry device
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Jul 1984
Decision
37d
Days
Class 2
Risk

K842221 is an FDA 510(k) clearance for the WAKO GLUCOSE C. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Wako Pure Chemical Industries, Ltd. (Mchenry, US). The FDA issued a Cleared decision on July 12, 1984 after a review of 37 days - a notably fast clearance 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: 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 Wako Pure Chemical Industries, Ltd. devices

Submission Details

510(k) Number K842221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1984
Decision Date July 12, 1984
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
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 74
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K842221.
DIATROL BLOOD GLUCOSE TEST SYS
K842684 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984
SYSTEMATE GLUCOSE 67215
K843151 · Em Diagnostic Systems, Inc. · Aug 1984
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE
K842393 · Boehringer Mannheim Corp. · Aug 1984
REFLOCHECK-S
K840962 · Boehringer Mannheim Corp. · Jun 1984
REFLOCHECK & GLUCOSE TEST STRIP SYS
K834271 · Boehringer Mannheim Corp. · Feb 1984
TDX GLUCOSE
K833069 · Abbott Laboratories · Nov 1983