Cleared Traditional

K931523 - QUANTIMETRIX C-CLEAR(TM)

K931523 is an FDA 510(k) clearance for QUANTIMETRIX C-CLEAR(TM), manufactured by Quantimetrix Corp.. The device is a Class 1 Chemistry device with product code JMA cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K931523 · Quantimetrix Corp. · Chemistry device
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Jun 1993
Decision
91d
Days
Class 1
Risk

K931523 is an FDA 510(k) clearance for the QUANTIMETRIX C-CLEAR(TM). Classified as Acid, Ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric) (product code JMA), Class I - General Controls.

Submitted by Quantimetrix Corp. (Hawthorne, US). The FDA issued a Cleared decision on June 25, 1993 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1095 - 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 Quantimetrix Corp. devices

FDA 510(k) Submission Details - K931523

510(k) Number K931523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1993
Decision Date June 25, 1993
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 88d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

JMA Device Classification - Class 1, General Controls

Product Code JMA Acid, Ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1095
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.