Cleared Traditional

K964590 - COLORMATE III

K964590 is an FDA 510(k) clearance for COLORMATE III, manufactured by Chromatics Color Sciences Intl., Inc.. The device is a Class 1 Chemistry device with product code MQM cleared through the Traditional 510(k) pathway after a 251-day FDA review.

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

FDA 510(k) Submission Details - K964590

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 88d · This submission: 251d
Pathway characteristics
Predicate-based equivalence.

MQM Device Classification - Class 1, General Controls

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.