Cleared Traditional

K854178 - IN-VITRO TEST FOR THE DETERMINATION OF CREATININE

K854178 is an FDA 510(k) clearance for IN-VITRO TEST FOR THE DETERMINATION OF ..., manufactured by Clinical Data, Inc.. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K854178 · Clinical Data, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
41d
Days
Class 2
Risk

K854178 is an FDA 510(k) clearance for the IN-VITRO TEST FOR THE DETERMINATION OF CREATININE. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), 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 862.1225 - 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

FDA 510(k) Submission Details - K854178

510(k) Number K854178 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
Combination Product No
PCCP Authorized No
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.

CGX Device Classification - Class 2, Special Controls

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - CGX Alkaline Picrate, Colorimetry, Creatinine

All 140
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K854178.
CREATININE REAGENT SET
K860418 · Sterling Diagnostics, Inc. · Feb 1986
CREATININE REAGENT SET
K855193 · Technostics Intl. · Jan 1986
VISION CREATININE
K854846 · Abbott Laboratories · Jan 1986
AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 &
K853888 · American Research Products Co. · Oct 1985
TECHNICON CHEMI
K852565 · Technicon Instruments Corp. · Jul 1985
CRE BUFFER CRE DYE
K851993 · Alpkem Corp. · May 1985