Cleared Traditional

K982307 - WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000 (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K982307 · Wallac, Inc. · Chemistry device
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Feb 1999
Decision
216d
Days
Class 2
Risk

K982307 is an FDA 510(k) clearance for the WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000. Classified as Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine (product code JNB), Class II - Special Controls.

Submitted by Wallac, Inc. (Norton, US). The FDA issued a Cleared decision on February 2, 1999 after a review of 216 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1555 - 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 Wallac, Inc. devices

Submission Details

510(k) Number K982307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1998
Decision Date February 02, 1999
Days to Decision 216 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
128d slower than avg
Panel avg: 88d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JNB Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1555
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.