Cleared Traditional

TDX GLUCOSE (K833069) - FDA 510(k) Clearance

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

K833069 · Abbott Laboratories · Toxicology device
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Nov 1983
Decision
60d
Days
Class 2
Risk

K833069 is an FDA 510(k) clearance for the TDX GLUCOSE. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 7, 1983 after a review of 60 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 Abbott Laboratories devices

Submission Details

510(k) Number K833069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1983
Decision Date November 07, 1983
Days to Decision 60 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
27d faster than avg
Panel avg: 87d · This submission: 60d
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 101
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K833069.
REFLOCHECK-S
K840962 · Boehringer Mannheim Corp. · Jun 1984
REFLOCHECK & GLUCOSE TEST STRIP SYS
K834271 · Boehringer Mannheim Corp. · Feb 1984
WAKO GLUCOSE C
K833257 · Wako Chemicals USA, Inc. · Dec 1983
VISIDEX II REAGENT STRIPS
K831989 · Miles Laboratories, Inc. · Aug 1983
LANCER MSH GLUCOSE DIAG. KIT
K822958 · Sherwood Medical Co. · Nov 1982
ACCUDEX REAGENT STRIPS
K821247 · Miles Laboratories, Inc. · May 1982