Cleared Traditional

K990654 - QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT

K990654 is an FDA 510(k) clearance for QUANTASE TOTAL GALACTOSE SCREENING ASSA..., manufactured by Quantase , Ltd.. The device is a Class 1 Chemistry device with product code JIA cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K990654 · Quantase , Ltd. · Chemistry device
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Jun 1999
Decision
112d
Days
Class 1
Risk

K990654 is an FDA 510(k) clearance for the QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT. Classified as Enzymatic Methods, Galactose (product code JIA), Class I - General Controls.

Submitted by Quantase , Ltd. (Perth, Scotland, GB). The FDA issued a Cleared decision on June 21, 1999 after a review of 112 days - within the typical 510(k) review window.

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: 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 Quantase , Ltd. devices

FDA 510(k) Submission Details - K990654

510(k) Number K990654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1999
Decision Date June 21, 1999
Days to Decision 112 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
24d slower than avg
Panel avg: 88d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

JIA Device Classification - Class 1, General Controls

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.

Regulatory Peers - JIA Enzymatic Methods, Galactose

Devices cleared under the same product code (JIA) and FDA review panel - the closest regulatory comparables to K990654.
GSP Neonatal Total Galactose kit
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K991498 · Neometrics, Inc. · Jun 1999
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K950481 · Isolab, Inc. · Feb 1996
IMMUCHEM GAL-MW EA
K951329 · Icn Pharmaceuticals, Inc. · Nov 1995