Cleared Traditional

RELIEF PLUS ONE REAGENT STRIP MODIFICATION (K934892) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

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 59
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K934892.
ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM
K944459 · Boehringer Mannheim Corp. · Apr 1996
ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS
K952875 · Boehringer Mannheim Corp. · Nov 1995
SIGMA GLUCOSE REAGENT
K933694 · Sigma Chemical Co. · Nov 1994
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM
K930979 · Boehringer Mannheim Corp. · Sep 1993
ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM
K923048 · Boehringer Mannheim Corp. · Oct 1992
ACCUDATA GLUCOSE TEST STATION
K924475 · Boehringer Mannheim Corp. · Oct 1992