Cleared Traditional

GLUCOSE TEST (K781342) - FDA 510(k) Clearance

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

K781342 · Wako Intl., Inc. · Chemistry device
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Aug 1978
Decision
27d
Days
Class 2
Risk

K781342 is an FDA 510(k) clearance for the GLUCOSE TEST. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Wako Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1978 after a review of 27 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 Intl., Inc. devices

Submission Details

510(k) Number K781342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1978
Decision Date August 31, 1978
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
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 59
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K781342.
REFLOCHECK & GLUCOSE TEST STRIP SYS
K834271 · Boehringer Mannheim Corp. · Feb 1984
TDX GLUCOSE
K833069 · Abbott Laboratories · Nov 1983
LANCER MSH GLUCOSE DIAG. KIT
K822958 · Sherwood Medical Co. · Nov 1982
STATTEK-GLUCOSE LOW LEVEL
K781075 · Boehringer Mannheim Corp. · Aug 1978
MULTISTAT III GLUCOSE TEST
K771471 · Instrumentation Laboratory CO · Sep 1977
GO/HPO-GLUCOSE REAGENT (TRINDER)
K770200 · Beckman Instruments, Inc. · Feb 1977