Cleared Traditional

K832926 - ENZYMATIC GLUCOSE DETERMINATION

K832926 is the FDA 510(k) clearance for ENZYMATIC GLUCOSE DETERMINATION by Seragen Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K832926 · Seragen Diagnostics, Inc. · Chemistry device
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Oct 1983
Decision
70d
Days
Class 2
Risk

K832926 is an FDA 510(k) clearance for the ENZYMATIC GLUCOSE DETERMINATION. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Seragen Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983 after a review of 70 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 Seragen Diagnostics, Inc. devices

Submission Details

510(k) Number K832926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1983
Decision Date October 28, 1983
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 88d · This submission: 70d
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 197
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K832926.
REFLOCHECK & GLUCOSE TEST STRIP SYS
K834271 · Boehringer Mannheim Corp. · Feb 1984
WAKO GLUCOSE C
K833257 · Wako Chemicals USA, Inc. · Dec 1983
TDX GLUCOSE
K833069 · Abbott Laboratories · Nov 1983
UNITIZED ENZYMATIC GLUCOSE TEST SET
K832159 · Stanbio Laboratory · Aug 1983
VISIDEX II REAGENT STRIPS
K831989 · Miles Laboratories, Inc. · Aug 1983
GLUCOSE OXIDASE/PEROXIDASE TEST
K831411 · King Diagnostics, Inc. · Jul 1983