Cleared Traditional

ROMEO(TM) MODEL 1000 (K872889) - FDA 510(k) Clearance

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

K872889 · Diva Medical Systems, Inc. · Chemistry device
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Apr 1988
Decision
265d
Days
Class 2
Risk

K872889 is an FDA 510(k) clearance for the ROMEO(TM) MODEL 1000. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Diva Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 13, 1988 after a review of 265 days - an extended review cycle.

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 Diva Medical Systems, Inc. devices

Submission Details

510(k) Number K872889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1987
Decision Date April 13, 1988
Days to Decision 265 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 88d · This submission: 265d
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 61
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K872889.
ROCHE CHLORIDE ELECTRODE
K890528 · Roche Diagnostic Systems, Inc. · Mar 1989
ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM
K883817 · Boehringer Mannheim Corp. · Dec 1988
TRACER(TM) II BLOOD GLUCOSE SYSTEM
K881908 · Boehringer Mannheim Corp. · Jul 1988
MODIFICATION OF ACCU-CHEK II
K863481 · Boehringer Mannheim Corp. · Apr 1987
ABBOTT SPECTRUM GLUCOSE REAGENT
K864224 · Abbott Laboratories · Jan 1987
TRACKER SYSTEM
K860948 · Boehringer Mannheim Corp. · Dec 1986