Cleared Traditional

COLORMATE III (K964590) - FDA 510(k) Clearance

Class I Chemistry device.

K964590 · Chromatics Color Sciences Intl., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
251d
Days
Class 1
Risk

K964590 is an FDA 510(k) clearance for the COLORMATE III. Classified as Bilirubin (total And Unbound) In The Neonate Test System (product code MQM), Class I - General Controls.

Submitted by Chromatics Color Sciences Intl., Inc. (Rockville, US). The FDA issued a Cleared decision on July 24, 1997 after a review of 251 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1113 - 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 Chromatics Color Sciences Intl., Inc. devices

Submission Details

510(k) Number K964590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1996
Decision Date July 24, 1997
Days to Decision 251 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 88d · This submission: 251d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQM Bilirubin (total And Unbound) In The Neonate Test System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1113
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.