Cleared Traditional

K854177 - IN-VITRO TEST FOR THE DETERMINATION OF ...

K854177 is the FDA 510(k) clearance for IN-VITRO TEST FOR THE DETERMINATION OF ... by Clinical Data, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K854177 · Clinical Data, Inc. · Chemistry device
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Nov 1985
Decision
41d
Days
Class 2
Risk

K854177 is an FDA 510(k) clearance for the IN-VITRO TEST FOR THE DETERMINATION OF GLUCOSE. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on November 25, 1985 after a review of 41 days - a notably fast clearance 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: 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 Clinical Data, Inc. devices

Submission Details

510(k) Number K854177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date November 25, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
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 128
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K854177.
GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER
K861303 · Miles Laboratories, Inc. · Jul 1986
GLUCOSE HK PROCEDURE
K861653 · Data Medical Associates, Inc. · May 1986
GLUCOSE OXIDASE PROCEDURE
K861204 · Data Medical Associates, Inc. · Apr 1986
QCA ENZYMATIC GLUCOSE
K853656 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1985
GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT
K851703 · Miles Laboratories, Inc. · Aug 1985
ACCU-CHEK II
K851456 · Boehringer Mannheim Corp. · Aug 1985