Cleared Traditional

K950481 - NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT

K950481 is an FDA 510(k) clearance for NEONATAL CHEMISTRY SYSTEM, manufactured by Isolab, Inc.. The device is a Class 1 Chemistry device with product code JIA cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K950481 · Isolab, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
363d
Days
Class 1
Risk

K950481 is an FDA 510(k) clearance for the NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT. Classified as Enzymatic Methods, Galactose (product code JIA), Class I - General Controls.

Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on February 1, 1996 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Isolab, Inc. devices

FDA 510(k) Submission Details - K950481

510(k) Number K950481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1995
Decision Date February 01, 1996
Days to Decision 363 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
275d slower than avg
Panel avg: 88d · This submission: 363d
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

All 8
Devices cleared under the same product code (JIA) and FDA review panel - the closest regulatory comparables to K950481.
QUANTASE TOTAL GALACTOSE SCREENING ASSAY
K990644 · Quantase , Ltd. · Jun 1999
QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
K990654 · Quantase , Ltd. · Jun 1999
ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
K991498 · Neometrics, Inc. · Jun 1999
IMMUCHEM GAL-MW EA
K951329 · Icn Pharmaceuticals, Inc. · Nov 1995