Cleared Traditional

K831989 - VISIDEX II REAGENT STRIPS

K831989 is the FDA 510(k) clearance for VISIDEX II REAGENT STRIPS by Miles Laboratories, Inc.. It is a Class 2 Toxicology device (product code CGA) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K831989 · Miles Laboratories, Inc. · Toxicology device
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Aug 1983
Decision
48d
Days
Class 2
Risk

K831989 is an FDA 510(k) clearance for the VISIDEX II REAGENT STRIPS. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 8, 1983 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1345 - the FDA toxicology 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K831989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1983
Decision Date August 08, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 87d · This submission: 48d
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 Toxicology devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 190
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K831989.
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
GLUCOSE OXIDASE/PEROXIDASE TEST
K831411 · King Diagnostics, Inc. · Jul 1983
GLUCOSCAN METER MODEL II
K822699 · Lifescan, Inc. · Nov 1982
LANCER MSH GLUCOSE DIAG. KIT
K822958 · Sherwood Medical Co. · Nov 1982