Cleared Traditional

K934892 - RELIEF PLUS ONE REAGENT STRIP MODIFICATION

K934892 is an FDA 510(k) clearance for RELIEF PLUS ONE REAGENT STRIP MODIFICATION, manufactured by Diagnostic Solutions, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K934892 · Diagnostic Solutions, Inc. · Chemistry device
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Jan 1994
Decision
113d
Days
Class 2
Risk

K934892 is an FDA 510(k) clearance for the RELIEF PLUS ONE REAGENT STRIP MODIFICATION. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Diagnostic Solutions, Inc. (Irvine, US). The FDA issued a Cleared decision on January 11, 1994 after a review of 113 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Solutions, Inc. devices

FDA 510(k) Submission Details - K934892

510(k) Number K934892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1993
Decision Date January 11, 1994
Days to Decision 113 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 88d · This submission: 113d
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 Chemistry devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 312
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K934892.
SIGMA GLUCOSE REAGENT
K933694 · Sigma Chemical Co. · Nov 1994
DMA GLUCOSE (OXIDASE) PROCEDURE
K943241 · Data Medical Associates, Inc. · Oct 1994
GLUCOFILM TEST STRIPS
K936212 · Heraeus Kulzer, Inc. · May 1994
GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION
K934898 · Heraeus Kulzer, Inc. · Dec 1993
GLUCOSTIX REAGENT STRIPS
K926362 · Heraeus Kulzer, Inc. · Nov 1993
CHOLESTECH L.D.X. SYSTEM
K932727 · Cholestech Corp. · Nov 1993