Cleared Traditional

K831411 - GLUCOSE OXIDASE/PEROXIDASE TEST

K831411 is an FDA 510(k) clearance for GLUCOSE OXIDASE/PEROXIDASE TEST, manufactured by King Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code CGA cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K831411 · King Diagnostics, Inc. · Microbiology device
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Jul 1983
Decision
65d
Days
Class 2
Risk

K831411 is an FDA 510(k) clearance for the GLUCOSE OXIDASE/PEROXIDASE TEST. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by King Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1983 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1345 - the FDA microbiology 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 King Diagnostics, Inc. devices

FDA 510(k) Submission Details - K831411

510(k) Number K831411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1983
Decision Date July 06, 1983
Days to Decision 65 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 102d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

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 Microbiology devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 302
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K831411.
UNITIZED ENZYMATIC GLUCOSE TEST SET
K832159 · Stanbio Laboratory · Aug 1983
VISIDEX II REAGENT STRIPS
K831989 · Miles Laboratories, Inc. · Aug 1983
GLUCOSE REAGENT B6360-11
K831634 · American Scientific Products · Jul 1983
GLUCOSE REAGENT KITS-B6370-10A
K831624 · American Scientific Products · Jul 1983
ENZYMATIC GLUCOSE DETERMINATION
K823474 · The Dow Chemical Co. · Dec 1982
GLUCOSCAN METER MODEL II
K822699 · Lifescan, Inc. · Nov 1982