Cleared Traditional

K991498 - ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL (FDA 510(k) Clearance)

Class I Chemistry device.

K991498 · Neometrics, Inc. · Chemistry device
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Jun 1999
Decision
48d
Days
Class 1
Risk

K991498 is an FDA 510(k) clearance for the ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL. Classified as Enzymatic Methods, Galactose (product code JIA), Class I - General Controls.

Submitted by Neometrics, Inc. (E. Northport, US). The FDA issued a Cleared decision on June 16, 1999 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1310 - 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 Neometrics, Inc. devices

Submission Details

510(k) Number K991498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1999
Decision Date June 16, 1999
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIA Enzymatic Methods, Galactose
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1310
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.